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Administrative data

Description of key information

-The acute eye irritation study ((Henkel KGaA.  1980) indicates that Alcohols, C12-14 was not irritating. 
Result: not irritating to eye. Based on the Draize scores reported it is considered that Alcohols, C12-14 is not not an eye irritant according to either EU or GHS criteria.. C12-14 alcohol is not irritating to the eye when applied undiluted.
- The results of the study (Henkel KGaA.  1980) indicate that Alcohols, C12-14 is irritant to skin. Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2. According to  GHS criteria the test substance is mild irritant  (class 3) with all individual 24+48=72 hour erythema scores  between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.
 - Respiratory irritation 
There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation of the aliphatic alcohols.
.

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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
other: Draize Test
Principles of method if other than guideline:
Primary Irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the rabbits, clipped free of hair. The 6 rabbits are used in abraded and intact skin tests.
Single 24-hour application to two sites each on the intact skin of 6 rabbits. After 24 hours exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Rabbit
- Strain: New Zealand White
- Sex: Male
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6
- Controls: No
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: none
Controls:
no
Amount / concentration applied:
- Preparation of test substance: Undiluted
- Area of exposure: Not reported.
- Occlusion: Under plaster.
- Vehicle: None
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: Not reported.
Duration of treatment / exposure:
24 hour(s
Observation period:
- Examination time points: 24, 48 and 72 hours and 4, 5, 6, 7 and 8 days after exposure
Number of animals:
6
Details on study design:
ADMINISTRATION/EXPOSURE 24 hour occluded exposure
- Preparation of test substance: Undiluted
- Area of exposure: Not reported.
- Occlusion: Under plaster.
- Vehicle: None
- Total volume applied: 0.5 ml
- Postexposure period: 14 days
- Removal of test substance: Not reported.

EXAMINATIONS
- Scoring system: Draize
- Examination time points: 24, 48 and 72 hours and 4, 5, 6, 7 and 8 days after exposure.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6,
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24+48+72 hours
Score:
2.3
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24+48+72 hours
Score:
2.3
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #1
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #2
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #3
Time point:
other: 24+48+72 hours
Score:
1
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #4
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #5
Time point:
other: 24+48+72 hours
Score:
1.7
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
other: Oedema
Basis:
animal #6
Time point:
other: 24+48+72 hours
Score:
2
Reversibility:
not fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24+48+72 hour
Score:
2
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritation parameter:
other: Oedema
Basis:
mean
Time point:
other: 24+48+72 hours
Score:
1.4
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
3.6
Reversibility:
fully reversible within: 6 day
Remarks on result:
other: REVERSIBILITY: All scores were 0 by day 6, the study was terminated at day 8.
Irritant / corrosive response data:
The test material produced a primary irritation index of 3.6 at 24 hours.
Erythema: Individual 1.7, 2.3, 2.0, 1.7, 2.0, 2.3 Group mean 2.0
Oedema: Individua 1.0 ,1.0 ,1.0 , 1.7, 1.7, 2.0 Group mean 1.4
Other effects:
None reported
Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2.
According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.
Executive summary:

Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2. According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.

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
Qualifier:
according to guideline
Guideline:
other: Draize Test
Principles of method if other than guideline:
The effect of repeated application to the skin of hairless mice was investigated using different concentrations of the test substance in olive oil. Groups of 5 mice were used.
GLP compliance:
yes
Species:
mouse
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- mice
- Strain:no data
- Sex: no data
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 5
- Controls: No
Type of coverage:
occlusive
Preparation of test site:
other: hairless
Vehicle:
other: olive oil
Controls:
no
Amount / concentration applied:
The effect of repeated application to the skin of hairless mice was investigated using different concentrations of the test substance in olive oil.
Groups of 5 mice were used.

2-3 drops of the test material or a dilution were applied to the dorsal skin as follows:
-100% and 50% twice daily for 4 days (8 applications)
-25% and 10% twice daily for 10 days (20 applications)
Duration of treatment / exposure:
4 days (8 applications)
10 days (20 applications)
Observation period:
24 hours,96 hours , 4 days, 10 days
Number of animals:
5
Details on study design:
The effect of repeated application to the skin of hairless mice was investigated using different concentrations of the test substance in olive oil.
Groups of 5 mice were used.

2-3 drops of the test material or a dilution were applied to the dorsal skin as follows:
-100% and 50% twice daily for 4 days (8 applications)
-25% and 10% twice daily for 10 days (20 applications)

Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Remarks on result:
other: Following a 24 hour occlusive exposure to mice skin a 100% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Remarks on result:
other: Following a 24 hour occlusive exposure to mice skin a 50% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 96 hours
Score:
0 - 2
Remarks on result:
other: Following a 96 hour occlusive exposure to mice skin a 50% and 100% solution of Alcohols, C12-14 is slightly irritating (after 8 aplications).
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 10 day
Score:
0
Remarks on result:
other: 25% and 10% solution of Alcohols, C12-14 (20 applications) is not irritant up to 10 days although slight effects were seen between days 3 and 6.
Irritant / corrosive response data:
100% and 50% non-irritant after 24 hours, slightly irritating at 96 hours (after 8 aplications).
The degree of irritation increased to 96 hours but there is no information on reversibility.
25% and 10% (20 applications) not irritant up to 10 days although slight effects were seen between days 3 and 6.
The concentration limit for no effect on the skin is 10%.
Other effects:
None reported
Interpretation of results:
other: slightly irritating
Remarks:
Following a 96 hour occlusive exposure to mice skin a 50% and 100% solution of Alcohols, C12-14 is slightly irritating (after 8 aplications). Criteria used for interpretation of results: EU
Conclusions:
Following a 24 hour occlusive exposure to mice skin a 100% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria.
Following a 24 hour occlusive exposure to mice skin a 50% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria
100% and 50% % solution of Alcohols, C12-14 are non-irritant after 24 hours.
Following a 96 hour occlusive exposure to mice skin a 50% and 100% solution of Alcohols, C12-14 is slightly irritating (after 8 aplications). The degree of irritation increased to 96 hours.
25% and 10% solution of Alcohols, C12-14 (20 applications) is not irritant up to 10 days although slight effects were seen between days 3 and 6.
Executive summary:

Following a 24 hour occlusive exposure to mice skin a 100% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria.

Following a 24 hour occlusive exposure to mice skin a 50% solution of Alcohols, C12-14 would not be considered irritant by either EU or GHS criteria

100% and 50% % solution of Alcohols, C12-14 are non-irritant after 24 hours.

Following a 96 hour occlusive exposure to mice skin a 50% and 100% solution of Alcohols, C12-14 is slightly irritating (after 8 aplications). The degree of irritation increased to 96 hours.

25% and 10% solution of Alcohols, C12-14 (20 applications) is not irritant up to 10 days although slight effects were seen between days 3 and 6.

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:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: other: patch test based on OECD 404
The effect on human skin was investigated:
15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested.
Age was 22 - 53 years with an average of 34.9 years.

GLP compliance:
yes
Species:
human
Strain:
other: male and female
Details on test animals or test system and environmental conditions:
15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested. Age was 22 - 53 years with an average of 34.9 years.
Type of coverage:
semiocclusive
Preparation of test site:
other:
Vehicle:
other: undiluted
Controls:
not specified
Amount / concentration applied:
15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested. Age was 22 - 53 years with an average of 34.9 years.

2-3 drops of the test material or a dilution were applied to the dorsal skin as follows:
-100% and 50% twice daily for 4 days (8 applications)
-25% and 10% twice daily for 10 days (20 applications)
Duration of treatment / exposure:
4 hour(s
Observation period:
1, 24, 48 and 72 hours
Number of animals:
20 male and female volunteers were tested. Age was 22 - 53 years with an average of 34.9 years.
Details on study design:
The effect on human skin was investigated:
15 drops/plaster of undiluted test substance were added to a semi-occlusive plaster (diameter: 1.5 cm) and applied for 4 hours to the backs of healthy volunteers. Readings of erythema, edema, scaling and fissures were taken 1, 24, 48 and 72 hours after application. 20 male and female volunteers were tested.
Age was 22 - 53 years with an average of 34.9 years.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 hours
Score:
0
Remarks on result:
other: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Irritant / corrosive response data:
Result: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).
Other effects:
None reported
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Alcohols, C12-14 is not irritating to human skin following a 4 hour semi-occlusive exposure.
Executive summary:

Result: No irritation was observed following application to the human skin of undiluted test substance for 4 hours (patch test).

Endpoint:
skin irritation: in vitro / ex vivo
Remarks:
other: human
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: open epicutaneous test according to Burckhardt 1996
Principles of method if other than guideline:
Method: other: open epicutaneous test according to Burckhardt 1996
The effect on human skin was investigated:
Undiluted test substance was applied to the forearm with a glass rod for a total application period of 60 minutes.
Every 30 seconds, the test substance was gently swabbed with tissue and new test substance applied.
Objective findings (erythema, edema) and subjective sensations (e.g. itching, cauterization etc.) were recorded after 15, 30, 45 and 60 minutes.
20 male and female volunteers of average age 35.3 years were tested.

GLP compliance:
yes
Species:
human
Strain:
other: male and female
Details on test animals or test system and environmental conditions:
Undiluted test substance was applied to the forearm with a glass rod for a total application period of 60 minutes.
Every 30 seconds, the test substance was gently swabbed with tissue and new test substance applied.
Objective findings (erythema, edema) and subjective sensations (e.g. itching, cauterization etc.) were recorded after 15, 30, 45 and 60 minutes.
20 male and female volunteers of average age 35.3 years were tested.
Type of coverage:
semiocclusive
Preparation of test site:
other:
Vehicle:
other: undiluted
Controls:
not specified
Amount / concentration applied:
Undiluted test substance was applied to the forearm with a glass rod for a total application period of 60 minutes.
Every 30 seconds, the test substance was gently swabbed with tissue and new test substance applied.
Objective findings (erythema, edema) and subjective sensations (e.g. itching, cauterization etc.) were recorded after 15, 30, 45 and 60 minutes.
20 male and female volunteers of average age 35.3 years were tested.
Duration of treatment / exposure:
1 hour
Observation period:
15, 30, 45 and 60 minutes
Number of animals:
20 male and female volunteers of average age 35.3 years were tested.

Details on study design:
The effect on human skin was investigated:
Undiluted test substance was applied to the forearm with a glass rod for a total application period of 60 minutes.
Every 30 seconds, the test substance was gently swabbed with tissue and new test substance applied.
Objective findings (erythema, edema) and subjective sensations (e.g. itching, cauterization etc.) were recorded after 15, 30, 45 and 60 minutes.
20 male and female volunteers of average age 35.3 years were tested.

Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Alcohols, C12-14 was not irritating to human skin following repeated application to non-occluded skin over a period of 1 hour.
Value:
0
Remarks on result:
other: No irritation was observed following application to the human skin of undiluted test substance for 1 hour
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Alcohols, C12-14 was not irritating to human skin following repeated application to non-occluded skin over a period of 1 hour.

Executive summary:

Alcohols, C12-14 was not irritating to human skin following repeated application to non-occluded skin over a period of 1 hour.

Result: No irritating effects or subjective sensations were observed

Endpoint:
skin irritation: in vitro / ex vivo
Remarks:
other: human
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: open epicutaneous test according to Burckhardt
Principles of method if other than guideline:
Method: other: open epicutaneous test according to Burckhardt .
The effect on human skin was investigated:
Single 8 hour application as a 10% solution in ethanol (patch test). 5 volunteers were tested.
Single 24 hour patch test with 10% solution in ethanol Burckhardt test, repeated aplication (x60) within 30 minutes of 10% solution in ethanol.


GLP compliance:
yes
Species:
human
Strain:
other: male and female
Details on test animals or test system and environmental conditions:
The effect on human skin was investigated:
Single 8 hour application as a 10% solution in ethanol (patch test). 5 volunteers were tested.
Single 24 hour patch test with 10% solution in ethanol Burckhardt test, repeated aplication (x60) within 30 minutes of 10% solution in ethanol.

Type of coverage:
semiocclusive
Preparation of test site:
other:
Vehicle:
other: ethanol
Controls:
not specified
Amount / concentration applied:
Single 8 hour application as a 10% solution in ethanol (patch test). 5 volunteers were tested.
Single 24 hour patch test with 10% solution in ethanol Burckhardt test, repeated aplication (x60) within 30 minutes of 10% solution in ethanol.


Duration of treatment / exposure:
8 hour(s
Observation period:
8, 24 hours
Number of animals:
5 volunteers
Details on study design:
The effect on human skin was investigated:
Single 8 hour application as a 10% solution in ethanol (patch test). 5 volunteers were tested.
Single 24 hour patch test with 10% solution in ethanol Burckhardt test, repeated aplication (x60) within 30 minutes of 10% solution in ethanol.

Irritation / corrosion parameter:
% tissue viability
Run / experiment:
No irritation was observed following application to the human skin of a 10% solution of the test substance in ethanol for 8 or 24 hours (patch test) or following repeated application in the Burhardt test.
Value:
0
Remarks on result:
other: No irritation was observed following application to the human skin of a 10% solution of the test substance in ethanol for 8 or 24 hours (patch test) or following repeated application in the Burhardt test.
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
No irritation was observed following application to the human skin of a 10% solution of the test substance in ethanol for 8 or 24 hours (patch test) or following repeated application in the Burhardt test.
Executive summary:

No irritation was observed following application to the human skin of a 10% solution of the test substance in ethanol for 8 or 24 hours (patch test) or following repeated application in the Burhardt test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye 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
Qualifier:
according to guideline
Guideline:
other: Draize Test
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TTEST ANIMALS:
-Rabbit
- Strain: New Zealand White
- Sex: Male
- Source: Not reported
- Age: Not reported
- Weight at study initiation: Not reported
- Number of animals: 6
- Controls: The untreated eye served as a control.




Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
6
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: Undiluted
- Amount of substance instilled: 0.1 ml
- Vehicle: none
- Postexposure period: 24 hours
- Controls: The untreated eye served as a control.

EXAMINATIONS
- Ophthalmoscopic examination: Not reported.
- Scoring system: Draize
- Observation period: 24 hours
- Tool used to assess score: Not reported.

Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hrs
Score:
0
Reversibility:
fully reversible
Remarks:
Fully reversible by 24 hours after instillation.
Remarks on result:
other: not rinsed. Draize scoring up to 24 hours post instillation. There was no involvement of the cornea or iris. Minimal conjunctival redness was noted (score <1) at 2 and 6 hours after instillation. All scores at 24 hours were 0.
Irritant / corrosive response data:
Draize scoring up to 24 hours post instillation. There was no involvement of the cornea or iris. Minimal conjunctival redness was noted (score <1) at 2 and 6 hours after instillation. All scores at 24 hours were 0.
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
This C12-14 alcohol is not irritating to the eye when applied undiluted.
Result: not irritating .

Executive summary:

This C12-14 alcohol is not irritating to the eye when applied undiluted.

Result: not irritating .

Endpoint:
eye irritation: in vivo
Type of information:
other: published data
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: New Zealand White
- Sex: male
- Source: David Perciva; Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.53-2.87kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet (ad libitum), (Special Diets Services Ltd., Witham, Essex, UK)
- Water: Mains drinking water (ad libitum)
- Acclimation period: Minimum of 5 days.
- Number of animals: 3
- Controls: Untreated eye used as control

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 45-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12




Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of each animal served as a control.
Amount / concentration applied:
TEST MATERIAL
- Preparation of test substance: the substance was a solid and was warmed in a warming bath to 40C prior to instillation.
- Amount of substance instilled: 0.1 ml
- Vehicle: None
- Postexposure period: 72 hours
- Concentration (if solution): undiluted
Duration of treatment / exposure:
A single instillation.
Observation period (in vivo):
1, 24, 48 and 72 hours.
Number of animals or in vitro replicates:
3, male
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): not rinsed.


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" Kay & Callandra (modified).


TOOL USED TO ASSESS SCORE: Light source from a standard opthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
0
Remarks on result:
other: not rinsed, REVERSIBILITY: All scores were 0 at 48 and 72 hours.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
0
Remarks on result:
other: not rinsed, REVERSIBILITY: All scores were 0 at 48 and 72 hours.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h,48h,72h
Score:
0.1
Max. score:
0.3
Remarks on result:
other: not rinsed, REVERSIBILITY: All scores were 0 at 48 and 72 hours.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
0
Remarks on result:
other: not rinsed, REVERSIBILITY: All scores were 0 at 48 and 72 hours.
Irritant / corrosive response data:
DESCRIPTION OF LESIONS:
No corneal or iridial effects were noted suring the study.
Moderate conjunctival irritation was noted in two treated eyes with minimal conjunctival irritation in the remaining treated eye one hour after treatment.
Minimal conjunctival redness was noted in one treated eye at the 24 hour observation point.
Other effects:
Conjunctival discharge was noted in all animals one hour after instillation.
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Kalcol 2098 (Dodecan-1-ol (C12)) is not irritating to the rabbit eye using either EU or GHS criteria. Classification: not irritating
Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component.
Executive summary:

Kalcol 2098 (Dodecan-1-ol (C12)) is not irritating to the rabbit eye using either EU or GHS criteria. Classification: not irritating

Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component.

Endpoint:
eye irritation, other
Remarks:
When instilled into the rabbit eye as a 10% solution in polyethylene glycol 400, Kalcol 4098 (Tetradecanol (C14) ) was not classified as an eye irritant by either EU of GHS criteria.
Type of information:
other: published data
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS: Rabbit
- Strain: New Zealand White
- Sex: male
- Source: David Percival Ltd, Cheshire, UK
- Age: 12-16 weeks
- Weight at study initiation: 2.56-2.80 kg
- Number of animals: 3
- Controls: Untreated eye used as control

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-20
- Humidity (%): 45-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12




Vehicle:
other: polyethylene glycol 400
Controls:
other: Untreated eye used as control
Amount / concentration applied:
- Preparation of test substance: the substance was prepared as a 10% solution in polyethylene glycol 400,
- Amount of substance instilled: 0.1 ml
- Vehicle: polyethylene glycol 400
- Postexposure period: 72 hours
Duration of treatment / exposure:
A single instillation.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3, male
Details on study design:
- Washing (if done): not rinsed.
- Scoring system: Draize and modified Kay and Calandra.
- Observation period: 72 hours
- Tool used to assess score: Standard ophthalmoscope.

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
0
Remarks on result:
other: not rinsed, REVERSIBILITY: All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0
Max. score:
0
Remarks on result:
other: not rinsed, REVERSIBILITY: All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24h,48h,72h
Score:
0.2
Max. score:
0.3
Remarks on result:
other: not rinsed,REVERSIBILITY: All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24,48,72h
Score:
0.1
Max. score:
0.3
Remarks on result:
other: not rinsed, REVERSIBILITY: All treated eyes appeared normal 48 and 72 hours after instillation.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
8.7
Reversibility:
fully reversible
Remarks on result:
other: Described as a minimal eye irritant according to modified Kay & Calandra.
Irritant / corrosive response data:
DESCRIPTION OF LESIONS:
At 1 hour post instillation Grade 2 redness of the conjunctival membrane was noted in 2 treated eyes with grade 1 redness of the conjunctival membrane noted in the remaining treated eye.
Conjunctival redness (grade 1) persisted in in 2 treated eyes at the 24 hour observation.
Chemosis was also observed in all eyes at 1 hour post instillation (grade1 and 2) persisting in one treaed eye until 24 hours. Grade 3 discharge was noted in 1 treated eye with grade 1 noted in one other treated eye at the 1 hour observation. No other evidence of eye irritation was noted during the study.
Other effects:
REVERSIBILITY: All treated eyes appeared normal 48 and 72 hours after instillation

Result:

AVERAGE SCORE (24+48+72 hour)

- Cornea: 0

- Iris: 0

- Conjunctivae (Redness): Individual scores 0.3, 0.3, 0 (group mean score 0.2)

- Conjunctivae (Chemosis): 0. 0, 0.3 (group mean score 0.1)

- Overall irritation score: maximum group mean score 8.7 at 1 hour post instillation. Described as a minimal eye irritant

according to modified Kay & Calandra.

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
When instilled into the rabbit eye as a 10% solution in polyethylene glycol 400, Kalcol 4098 (Tetradecanol (C14) ) was not classified as an eye irritant by either EU of GHS criteria.Classification: not irritating
Tetradecanol (C14) ) is supporting substance for Alcohols,C12-C14 and the one of the component in Alcohols,C12-C14 .
Executive summary:

When instilled into the rabbit eye as a 10% solution in polyethylene glycol 400, Kalcol 4098 (Tetradecanol (C14) ) was not classified as an eye irritant by either EU of GHS criteria.Classification: not irritating

Tetradecanol (C14) ) is supporting substance for Alcohols,C12-C14 and the one of the component in Alcohols,C12-C14 .

Endpoint:
eye irritation: in vivo
Type of information:
other: published data
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Sex: male
-Number of animals: 3
- Controls: Untreated eye used as control
- Weight at study initiation: 2.69-3.01kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet: STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: minimum of five days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 17-19C
- Humidity (%): 56-61%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12h/12h
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): A volume of 0.1ml of the test material which was found to weight approximately78mg was applied to the eye.


VEHICLE

-No vehicle.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
1h, 24h, 48h, 72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): No washing reported.


SCORING SYSTEM: Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the toxicity of Household Substances,National Academy of Sciences, Washington DC p. 48 to 49. Classification According to a Modified Version of the Kay and Calandra System

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard opthalmoscope.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Iridial inflammation
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #1
Time point:
other: mean 24h,48h,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #1
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Iridial infalmmation
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #2
Time point:
other: mean 24,48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Iridial inflammation.
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritation parameter:
other: Conjunctival redness
Basis:
animal #3
Time point:
other: mean 24, 48,72h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: Conjunctival chemosis
Basis:
animal #3
Time point:
other: mean 24,48,72h
Score:
0
Max. score:
0
Reversibility:
other: No initial effect.
Irritant / corrosive response data:
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letter E (degree of opacity) and F (area of opacity). For each tissue the score was calculated as follows:

Score for the conjunctivae - (A+B+C)x2
Score for iris - Dx5
Score for cornea - (ExF)x5

Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C, J.Soc.Cosmet Chem., 1962 13 281-289 wasused to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. If any rabbit shows irreversible oculardamage the test material will be classified as corrosive to the eye.

Overall irritation score: Maximum group mean score 15.3 at 1 hour post instillation. Classified as a mild irritant according to a modified Kay and
Calandra system.
Other effects:
DESCRIPTION OF LESIONS: Dulling of the cornea noted in 2 animals 1 hour after instillation, diffuse corneal opacity noted in 1 rabbit at 24 hours
post instillation. Iridial inflammation noted in 2 animals at 1 hour post instillation only. Moderate conjunctival irritation noted in all eyes at 1 hour
which reduced to minimal conjunctival irritation at 24 hours.
REVERSIBILITY: All eyes were normal at 48 and 72 hours post instillation.
OTHER EFFECTS: Residual test material noted around the treated eyes at 1 hour post instillation.
Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Kalcol 6098 (Hexadecan-1-ol (C16))is not an eye irritant according to EU or GHS criteria.Classification: not irritating.
-Hexadecan-1-ol (C16) is supporting substance for Alcohols,C12-C14 and the one of the component in Alcohols,C12-C14 .
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

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

Additional information

Eye irritation

 

-The acute eye irritation study ((Henkel KGaA. 1980) indicates that Alcohols, C12-14 was not irritating.

Result: not irritating to eye. Based on the Draize scores reported it is considered that Alcohols, C12-14 is not not an eye irritant according to either EU or GHS criteria.. C12-14 alcohol is not irritating to the eye when applied undiluted.

The eye irritation potential for alcohols with a chain length of C12 and above has been shown to be minimal.

Result: not irritating.

Kalcol 2098 (Dodecan-1-ol (C12)) is not irritating to the rabbit eye using either EU or GHS criteria. Classification: not irritating

Dodecan-1-ol (C12) is supporting substance for Alcohols,C12-C14 and the main component.

Based on the descriptions of the lesions it is considered that Alcohols, C12-14 is not irritating to eye according to EU criteria or GHS criteria.

  

 Skin irritation

Linear Alcohols.The data demonstrate that lower members of the linear alcohols (C6 – C11) have a skin irritancy potential ranging from mild to irritant, when applied undiluted for 4 – 24 hours. Application of diluted materials resulted in a lower grade irritation. The skin irritation potential of linear alcohols in the range C12 and C16 is graded as mild - essentially non-irritant. Alcohols with a carbon chain length C18 and above were generally without evidence of a skin irritation potential.

Conclusion:Aliphatic alcohols in the range C6 – C11 are mild irritants, not anticipated to be corrosive.

 Aliphatic alcohols in the range C12 – C16 have a low degree of skin irritation potential; alcohols with chain lengths of C18 and above are non-irritant to skin.

-The results of the study (Henkel KGaA. 1980) indicate that Alcohols, C12-14 is irritant to skin. Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2. According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.

Result: irritating.

Based on the descriptions of the lesions it is considered that Alcohols, C12-14 is irritating to skin according to EU criteria and

mild irritant (class 3) according to GHS criteria

  

Respiratory irritation.

There is no information available from single or repeated inhalation exposures in laboratory animals or from human experience allowing a conclusion on potential respiratory tract irritation of the aliphatic alcohols.

 


Justification for selection of skin irritation / corrosion endpoint:
Alcohols, C12-14 is a skin irritant according to EU criteria based on a group 24+48+72 hour mean score for erythema of 2.
According to GHS criteria the test substance is mild irritant (class 3) with all individual 24+48=72 hour erythema scores between 1.7 - 2.3 (only 2/6 gave a reading of 2.3) following a 24 hour occluded application to rabbit skin.

Justification for selection of eye irritation endpoint:
The C12-14 alcohol is not irritating to the eye when applied undiluted.
Result: not irritating .

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the hazard assessment of  Alcohols, C12-14 in section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Skin Corrosivity C

R35 Causes severe burns

R34 Causes burns

Skin Irritation Xi

R38 Irritating to skin

R43 May cause sensitization by skin contact

Eye Irritation (Ocular Lesions) Xi

R36 Irritating to eyes

R37 irritating to respiratory system

R41 Risk of serious damage to eyes

CLP

 

Skin Corrosivity 

H314 Skin Corr 1A Causes severe skin burns and eye damage

H314 Skin Corr 1B Causes severe skin burns and eye damage

Skin Irritation 

H315 Skin Irrit. 2 Causes skin irritation

H317 Skin Sens. 1 May cause an allergic skin reaction

Eye Irritation (Ocular Lesions) Xi

H319 Eye Irrit. 2 Causes serious eye irritation

H318 Eye Dam. 1 Causes serious eye damage

H335 STOT SE 3 May cause respiratory irritation

 

 

It is concluded that the substance Alcohols, C12-14 meet the criteria to be classified for human health hazards for Dermal-local effect R38 Irritating to skin, H315 Skin Irrit. 2 Causes skin irritation

  

It is concluded that the substance Alcohols, C12-14 does not meet the criteria to be classified for human health hazards for respiratory irritation