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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No information was available on the test substance, therefore read across was used to fill the endpoint.

For skin irritation, one key study was available conducted on palmitic acid in humans. Palmitic acid was found to be non-irritating to human skin in the patch test. Four supporting patch tests are also available conducted on oleic acid, stearic acid, palmitic acid and linoleic acid. Only linoleic acid was observed to be minimally irritating in the human patch test. A Klimisch 4 study was also available from the Cosmetics Ingredient Review conducted with glyceryl oleate in rabbits. Glyceryl oleate in corn oil was found to be minimally irritating in dermal irritation studies with rabbits.

Skin corrosion was assessed in Klimich 4 studies only. Four fatty acids (palmitic acid, stearic acid, linoleic acid and oleic acid) were assessed in 4 -hour patch test in the rabbit, and all found to be non-corrosive.

For eye irritation, only Klimisch 4 studies were available. Four fatty acids (palmitic acid, stearic acid, linoleic acid and oleic acid) were assessed in the rabbit and found to be a non-irritant to rabbit eye. A Klimisch 4 study was also available from the Cosmetics Ingredient Review conducted with glyceryl oleate in rabbits. Glyceryl oleate in corn oil was found to produce slight conjunctivitis in rabbit eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
7
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
7 d
Score:
6
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
other: 5 d
Score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
On treatment days 1 to 3, 0/10 men showed erythema; on treatment day 4, 1/10 men showed erythema; on treatment day 5, 4/10 men showed erythema; on treatment days 6 to 7, 6/10 men showed erythema, on treatment days 7 to 10, 7/10 men showed erythema.
Interpretation of results:
study cannot be used for classification
Conclusions:
Linoleic acid produced significant irritation (erythema) during a human patch test, therefore linoleic acid was classed as irritating.
Executive summary:

The relative irritancy of linoleic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M linoleic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml linoleic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. Significant irritation (erythema) was observed in 7/10 men on study days 7 through 10. Therefore, linoleic acid was classed as irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
0/10 men showed detectable erythema at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Oleic acid produced no irritation (erythema) during a human patch test, therefore oleic acid was classed as non-irritating.
Executive summary:

The relative irritancy of oleic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M oleic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml oleic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. No irritation (erythema) was observed in any men on study days 1 through 10. Therefore, oleic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Determine the skin irritation potential in the human 4-h patch test.
- Short description of test conditions: Patch tests with the test material are applied to human skin for up to 4 hours.
- Parameters analysed / observed: The presence of irritation is observed at 24, 48 and 72 hours after patch removal.
GLP compliance:
not specified
Species:
other: Human
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): Not specified
Duration of treatment / exposure:
Test materials applied progressively for 15 minutes, 30 minutes, 1, 2, 3 and 4 hours. Each progressive application is at a new skin site.
Observation period:
Treatment sites assessed at 24, 48 and 72 hours after patch removal.
Number of animals:
29
Details on study design:
TEST SITE
- Type of patch: 25 mm plain Hill Top Chamber containing a Webril pad
- Site of application: Skin of the upper outer arm
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Of the 29 skin patches applied to humans, none produced positive irritant reactions.
Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid was non-irritating in the human patch test.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Plain 25 mm Hill Top Chamber patches, containing a Webril pad, with 0.2 ml palmitic acid, were applied to the skin of the upper outer arm of 29 human volunteers for up to 4 hours. The patches were removed after 4 hours, and the skin reaction at each site was observed 24, 48 and 72 hours after patch removal. Of the 29 humans assessed, 0 showed positive irritancy reactions when treated with palmitic acid patch tests. Therefore, palmitic acid was considered non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 0.5 and 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
1.0 M
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Remarks:
0.5 M
Irritant / corrosive response data:
1/10 men showed detectable erythema at 0.5 M at the site of application on treatment days 6 to 10.
0/10 men showed detectable erythema at 1.0 M at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Palmitic acid produced minimal irritation (erythema) during a human patch test, therefore palmitic acid was classed as non-irritating.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Individual A1 -test patches, with 0.5 and 1.0 M palmitic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml palmitic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. Minimal irritation (erythema) was observed in one man on study days 6 to 10 at 0.5 M. No irritation (erythema) was observed in any men on study days 1 through 10 at 1.0 M. Therefore, palmitic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
0/10 men showed detectable erythema at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Stearic acid produced no irritation (erythema) during a human patch test, therefore stearic acid was classed as non-irritating.
Executive summary:

The relative irritancy of stearic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M stearic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml stearic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. No irritation (erythema) was observed in any men on study days 1 through 10. Therefore, stearic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
Not specified.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 50% and 100%

VEHICLE
- Concentration (if solution): 0 and 50%
Duration of treatment / exposure:
Not specified.
Observation period:
2 and 24 hours after exposure.
Number of animals:
9
Details on study design:
Not specified.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
> 0.5 - <= 1
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Remarks on result:
not measured/tested
Irritation parameter:
primary dermal irritation index (PDII)
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Minimally irritating - produced erythema scores ranging from 0.5 to 1.
Other effects:
Not specified.
Conclusions:
Glyceryl oleate was found to be minimally irritating in rabbits.
Executive summary:

Glyceryl oleate was assessed in 5 dermal irritation studies in rabbits. The test substance, glyceryl oleate, was applied occlusively undiluted and 50% in corn oil to the clipped backs of 9 rabbits. Glyceryl oleate was found to be minimally irritating with erythema scores ranging from 0.5 to 1.

Endpoint:
skin corrosion: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
7
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
7 d
Score:
6
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
other: 5 d
Score:
4
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
On treatment days 1 to 3, 0/10 men showed erythema; on treatment day 4, 1/10 men showed erythema; on treatment day 5, 4/10 men showed erythema; on treatment days 6 to 7, 6/10 men showed erythema, on treatment days 7 to 10, 7/10 men showed erythema.
Interpretation of results:
study cannot be used for classification
Conclusions:
Linoleic acid produced significant irritation (erythema) during a human patch test, therefore linoleic acid was classed as irritating.
Executive summary:

The relative irritancy of linoleic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M linoleic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml linoleic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. Significant irritation (erythema) was observed in 7/10 men on study days 7 through 10. Therefore, linoleic acid was classed as irritating.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
0/10 men showed detectable erythema at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Oleic acid produced no irritation (erythema) during a human patch test, therefore oleic acid was classed as non-irritating.
Executive summary:

The relative irritancy of oleic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M oleic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml oleic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. No irritation (erythema) was observed in any men on study days 1 through 10. Therefore, oleic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Determine the skin irritation potential in the human 4-h patch test.
- Short description of test conditions: Patch tests with the test material are applied to human skin for up to 4 hours.
- Parameters analysed / observed: The presence of irritation is observed at 24, 48 and 72 hours after patch removal.
GLP compliance:
not specified
Species:
other: Human
Strain:
not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): Not specified
Duration of treatment / exposure:
Test materials applied progressively for 15 minutes, 30 minutes, 1, 2, 3 and 4 hours. Each progressive application is at a new skin site.
Observation period:
Treatment sites assessed at 24, 48 and 72 hours after patch removal.
Number of animals:
29
Details on study design:
TEST SITE
- Type of patch: 25 mm plain Hill Top Chamber containing a Webril pad
- Site of application: Skin of the upper outer arm
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Of the 29 skin patches applied to humans, none produced positive irritant reactions.
Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid was non-irritating in the human patch test.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Plain 25 mm Hill Top Chamber patches, containing a Webril pad, with 0.2 ml palmitic acid, were applied to the skin of the upper outer arm of 29 human volunteers for up to 4 hours. The patches were removed after 4 hours, and the skin reaction at each site was observed 24, 48 and 72 hours after patch removal. Of the 29 humans assessed, 0 showed positive irritancy reactions when treated with palmitic acid patch tests. Therefore, palmitic acid was considered non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 0.5 and 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Remarks:
1.0 M
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
1
Reversibility:
not specified
Remarks on result:
probability of weak irritation
Remarks:
0.5 M
Irritant / corrosive response data:
1/10 men showed detectable erythema at 0.5 M at the site of application on treatment days 6 to 10.
0/10 men showed detectable erythema at 1.0 M at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Palmitic acid produced minimal irritation (erythema) during a human patch test, therefore palmitic acid was classed as non-irritating.
Executive summary:

The relative irritancy of palmitic acid was assessed in a human patch test. Individual A1 -test patches, with 0.5 and 1.0 M palmitic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml palmitic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. Minimal irritation (erythema) was observed in one man on study days 6 to 10 at 0.5 M. No irritation (erythema) was observed in any men on study days 1 through 10 at 1.0 M. Therefore, palmitic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: To assess the relative irritancy of free fatty acids of different chain lengths.
- Short description of test conditions: The free fatty acids were applied daily under occlusive patch tests to human skin.
- Parameters analysed / observed: Patch tests applied until detectable erythema appeared.
GLP compliance:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material:
Analabs, New Haven, Conn.
Species:
other: Human
Strain:
other: White
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: Propanol
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.04 ml
- Concentration (if solution): 1.0 M
Duration of treatment / exposure:
24 hours for 10 days
Observation period:
30 minutes
Number of animals:
10 males per concentration
Details on study design:
TEST SITE
- Area of exposure: Interscapular area on back
- Type of patch: A1-test patches
- Type of tape: Blenderm tape
Irritation parameter:
other: Number of men showing erythema
Basis:
mean
Time point:
10 d
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
0/10 men showed detectable erythema at the site of application on treatment days 1 to 10.
Interpretation of results:
GHS criteria not met
Conclusions:
Stearic acid produced no irritation (erythema) during a human patch test, therefore stearic acid was classed as non-irritating.
Executive summary:

The relative irritancy of stearic acid was assessed in a human patch test. Individual A1 -test patches, with 1.0 M stearic acid, were applied to the interscapular area of the back of white males. Approximately 0.04 ml stearic acid was pipetted onto the test patch, and the patches were applied to the back and occluded with Blenderm tape. The patches were removed after 24 hours, and the skin reaction at each site was observed 30 minutes later. This process continued for 10 exposure days, until detectable erythema was observed at the site of the patch test. No irritation (erythema) was observed in any men on study days 1 through 10. Therefore, stearic acid was classed as non-irritating.

Endpoint:
skin irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
Not specified.
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 50% and 100%

VEHICLE
- Concentration (if solution): 0 and 50%
Duration of treatment / exposure:
Not specified.
Observation period:
2 and 24 hours after exposure.
Number of animals:
9
Details on study design:
Not specified.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
> 0.5 - <= 1
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Remarks on result:
not measured/tested
Irritation parameter:
overall irritation score
Remarks on result:
not measured/tested
Irritation parameter:
primary dermal irritation index (PDII)
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Minimally irritating - produced erythema scores ranging from 0.5 to 1.
Other effects:
Not specified.
Conclusions:
Glyceryl oleate was found to be minimally irritating in rabbits.
Executive summary:

Glyceryl oleate was assessed in 5 dermal irritation studies in rabbits. The test substance, glyceryl oleate, was applied occlusively undiluted and 50% in corn oil to the clipped backs of 9 rabbits. Glyceryl oleate was found to be minimally irritating with erythema scores ranging from 0.5 to 1.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
equivalent or similar to guideline
Guideline:
other: Draize eye test
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted and 50% in corn oil
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Not specified.
Other effects:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
Glyceryl oleate was found to be minimally irritating in the eyes of rabbits.
Executive summary:

Glyceryl oleate was assessed in 6 rabbits. The test substance, glyceryl oleate, was applied undiluted and 50% in corn oil to the eyes of 6 rabbits, and rabbits were observed for 2 days. Glyceryl oleate was found to be minimally irritating with irritation scores ranging from 0 to 1.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 0.3%; C16 = 13.0%; C18 = 4.1%; C18:1 = 23.3%; C18:2 = 53.0%; C18:3 = 6.2%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Mild conjunctival erythema with complete clearing in 72 hours.
Interpretation of results:
study cannot be used for classification
Conclusions:
Linoleic acid indicated mild signs of eye irritation in rabbits that were fully reversible within 72 hours.
Executive summary:

Six rabbits were used for this study. The test substance, linoleic acid, was tested for eye irritation in the rabbits. Linoleic acid showed mild conjunctival erythema in rabbits treated with linoleic acid, that was completely reversible within 72 hours. Therefore, linoleic acid was not classed as an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C12 = 0.4%; C14 = 2.7%; C14:1 = 1.0% C16 = 4.5%; C16:1 = 6.2%; C17 = 1.2%; C18 = 1.6%; C18:1 = 74.7%; C18:2 = 7.4%; C18:3 = 0.4%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Mild conjunctivitis with complete clearing in 72 hours.
Interpretation of results:
study cannot be used for classification
Conclusions:
Oleic acid indicated mild signs of eye irritation in rabbits that were fully reversible within 72 hours.
Executive summary:

Six rabbits were used for this study. The test substance, oleic acid, was tested for eye irritation in the rabbits. Oleic acid showed mild conjunctivitis in rabbits treated with oleic acid, that was completely reversible within 72 hours. Therefore, oleic acid was not classed as an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritation / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 2.0%; C16 = 95%; C18 = 3.0%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid indicated no signs of eye irritation in rabbits.
Executive summary:

Six rabbits were used for this study. The test substance, palmitic acid, was tested for eye irritation in the rabbits. Palmitic acid showed no signs of eye irritation in any rabbit tested.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 0.2%; C16 = 7.7%; C17 = 0.2%; C18 = 91.9%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Interpretation of results:
study cannot be used for classification
Conclusions:
Stearic acid indicated no signs of eye irritation in rabbits.
Executive summary:

Six rabbits were used for this study. The test substance, stearic acid, was tested for eye irritation in the rabbits. Stearic acid showed no signs of eye irritation in any rabbit tested.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
equivalent or similar to guideline
Guideline:
other: Draize eye test
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
other: Corn oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): Undiluted and 50% in corn oil
Observation period (in vivo):
2 days
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
1
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
Not specified.
Other effects:
Not specified.
Interpretation of results:
study cannot be used for classification
Conclusions:
Glyceryl oleate was found to be minimally irritating in the eyes of rabbits.
Executive summary:

Glyceryl oleate was assessed in 6 rabbits. The test substance, glyceryl oleate, was applied undiluted and 50% in corn oil to the eyes of 6 rabbits, and rabbits were observed for 2 days. Glyceryl oleate was found to be minimally irritating with irritation scores ranging from 0 to 1.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 0.3%; C16 = 13.0%; C18 = 4.1%; C18:1 = 23.3%; C18:2 = 53.0%; C18:3 = 6.2%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Mild conjunctival erythema with complete clearing in 72 hours.
Interpretation of results:
study cannot be used for classification
Conclusions:
Linoleic acid indicated mild signs of eye irritation in rabbits that were fully reversible within 72 hours.
Executive summary:

Six rabbits were used for this study. The test substance, linoleic acid, was tested for eye irritation in the rabbits. Linoleic acid showed mild conjunctival erythema in rabbits treated with linoleic acid, that was completely reversible within 72 hours. Therefore, linoleic acid was not classed as an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C12 = 0.4%; C14 = 2.7%; C14:1 = 1.0% C16 = 4.5%; C16:1 = 6.2%; C17 = 1.2%; C18 = 1.6%; C18:1 = 74.7%; C18:2 = 7.4%; C18:3 = 0.4%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritant / corrosive response data:
Mild conjunctivitis with complete clearing in 72 hours.
Interpretation of results:
study cannot be used for classification
Conclusions:
Oleic acid indicated mild signs of eye irritation in rabbits that were fully reversible within 72 hours.
Executive summary:

Six rabbits were used for this study. The test substance, oleic acid, was tested for eye irritation in the rabbits. Oleic acid showed mild conjunctivitis in rabbits treated with oleic acid, that was completely reversible within 72 hours. Therefore, oleic acid was not classed as an eye irritant.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritation / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 2.0%; C16 = 95%; C18 = 3.0%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Interpretation of results:
study cannot be used for classification
Conclusions:
Palmitic acid indicated no signs of eye irritation in rabbits.
Executive summary:

Six rabbits were used for this study. The test substance, palmitic acid, was tested for eye irritation in the rabbits. Palmitic acid showed no signs of eye irritation in any rabbit tested.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included under 'Attached justification' in IUCLID section 13 and 'Cross-reference'.
Reason / purpose for cross-reference:
read-across source
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: Test the eye irritation of fatty acids in rabbits.
- Parameters analysed / observed: Eye irritatiion / erythema.
GLP compliance:
not specified
Specific details on test material used for the study:
Composition:
C14 = 0.2%; C16 = 7.7%; C17 = 0.2%; C18 = 91.9%
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Not specified.
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Not specified.
Duration of treatment / exposure:
Not specified.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
Not specified.
Irritation parameter:
other: Level of irritancy
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: Not reported.
Interpretation of results:
study cannot be used for classification
Conclusions:
Stearic acid indicated no signs of eye irritation in rabbits.
Executive summary:

Six rabbits were used for this study. The test substance, stearic acid, was tested for eye irritation in the rabbits. Stearic acid showed no signs of eye irritation in any rabbit tested.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

One key study in humans (Klimisch 2) was available for the skin irritation endpoint, producing no adverse effects. Five supporting studies were also available, four human patch tests producing minimal effects and one in vivo study in rabbits. Although for glyceryl monoesters minimal irritation in dermal irritation studies with rabbits was observed, the results were below the trigger value for classification for skin irritation stated in the CLP guidance. All studies available for the skin corrosion endpoint were Klimisch 4 in vivo studies in rabbits, and showed no adverse effects for any fatty acid tested. All studies available for the eye irritation endpoint were Klimisch 4 in vivo studies in rabbits. For the fatty acids assessed, no adverse effects were observed. Although for glyceryl monoesters minimal irritation in eye irritation studies with rabbits was observed, the results were below the trigger value for classification for according to the CLP guidance. Therefore, according to CLP Regulation (EC) No 1272/2008, Guidance on the Application of the CLP Criteria" (ECHA 2017) and the 8th Adaptation to Technical Progress to CLP Regulation, the test item is not classified as a skin irritant or eye irritant.