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Diss Factsheets

Administrative data

Description of key information

Irritation / corrosion:
- skin: not irritating (OECD 404; Analogy CAS 57-10-3, CAS 57-11-4);
- eye: not irritating (OECD 405; Analogy CAS 57-10-3, CAS 57-11-4);

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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
29 Jan - 04 Feb 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
occlusive dressing; no details on reading time points
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Commission Directive 84/449/EEC
Deviations:
yes
Remarks:
occlusive dressing; no details on reading time points
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrusse, Chbb: HM
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae, Biberach, Germany
- Weight at study initiation: mean: 2452.5 g
- Housing: individually housed in rabbit batteries, Fa. Heinkel, Kuchen, Germany
- Diet: Zucht- /Haltungsdiät 20 ZH 5, Fa. Nohrlin GmbH, Bad Salzuflen, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 20 - 21
- Humidity (%): approx. 45 - 50
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
4 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area
- Type of wrap if used: The substance was applied to the intact skin using a patch (2.5x2.5 cm), which was covered by a plastic foil using adhesive plasters and an acrylastic band aid.

SCORING SYSTEM: Draize Scoring System
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3 and #4
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3 and #4
Time point:
other: mean over all reading time points
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal:
Remarks:
#1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
no details on reading time points given
Irritation parameter:
edema score
Basis:
animal:
Remarks:
#1, #2, #3, #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other:
Remarks:
no details on reading time points given
Irritant / corrosive response data:
No skin reactions were observed.
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test procedure according to national standard standard methods performed with the source substance CAS 57-11-4. In accordance to the ECHA guidance document "Practical guide: How to use alternatives to animal testing" (July 2016), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
other: Patch test / Revised (1964) Federal Hazardous Substance Act
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Reading time points: 24 and 72 hours
Number of animals:
6
Details on study design:
Fur was removed from the back of each of six rabbits by clipping the saddle of the trunk area. One area of skin was abraded by making minor incisions with a hypodermic needle. 0.5 mL of test material was applied to 1 in2 gauze patches. The patches were placed on both intact skin and abraded skin of each rabbit and secured with adhesive tape, rubber dental damming secured with staples, and gauze wound loosely around the trunk. The animals were then immobilized for 24 hours in wooden stocks. After 24 hours, the patches were removed and the skin cleaned by gently sponging with a moistened towel. The skin was examined immediately after removal of the patches (24 hours reading) and again at 72 hours. At each examination the skin was scored for presence and severity of erythema/eschar formation and edema formation.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact sites
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: intact sites
Irritant / corrosive response data:
No signs of skin irritation were observed on intact or abraded sites at either scoring time point.

Material (0.5 ml) was applied via a one-inch-square surgical gauze patch to intact and abraded-skin sites. Patches were held in place for 24 hours. Reactions were scored immediately after patch removal and two days later (72 hours).

Table 1: Scores for Skin Irritation

Observation time Rabbit no.
43 44 45 46 47 48
Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema
24 h 0 0 0 0 0 0 0 0 0 0 0 0
48 h No experimental data available; for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption)
72 h 0 0 0 0 0 0 0 0 0 0 0 0

Table 2: Calculation of mean scores

  Rabbit no.
43 44 45 46 47 48
Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema Erythema Edema
Mean value 24 + 48 + 72 h* 0 0 0 0 0 0 0 0 0 0 0 0

*No 48 h data are available: for calculation of mean scores, the 48 h values were assumed to be the same as those at 24 h (worst case assumption: persistence of effects seen at 24 h over 48 h).

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
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:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Qualifier:
according to guideline
Guideline:
other: Regulation for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Title 49, Department of Transportation Code of Federal Regulation, Section 173, 240 (Federal Register, February 12, 1973)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: effects noted in 2/6 animals
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects noted
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects noted
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects noted

Mild conjunctival erythema was shown in 2 of 6 animals at 24 and 48 hours while all signs of irritation hat subsided completely in 72 hours.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
26 Feb - 04 Mar 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance CAS 57-10-3. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
other: Kleinrussen Chbb
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HM / Fa. Thomae, Biberach, Germany
- Weight at study initiation: ca. 2640 g
- Housing: individually (Fa. Heinkel, Kuchen, Germany)
- Diet (ad libitum): Altromin diet 2023, Altromin GmbH, Lage, Germany
- Water (ad libitum): community tap water; ad libitum
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 20 - 21
- Humidity (%): 45 - 55
- Photoperiod (hrs dark / hrs light): 12 / 12
Vehicle:
unchanged (no vehicle)
Controls:
other: left eyes of the same animals were used for control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
permanent, without washing-off
Observation period (in vivo):
3 days (since only minor scores were observed that fully returned to normal within 3 days the experiment was cancelled due to animal welfare reasons; therefore the reduced observation period does not represent a deviation to the OECD guideline)
Number of animals or in vitro replicates:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
other: exudation
Basis:
mean
Remarks:
4 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects

Tab.1: Conjunctival reactions after application of 0.1 g Edenor C16 - 92/94 (undiluted, permanent, 4 male rabbits)

Time point after application

Redness

Chemosis

Exudation

Individual data

Average

Individual data

Average

Individual data

Average

60 min

1 / 1 / 1 / 1

1.00

0 / 1 / 1 /1

0.75

0 / 0 / 0 / 1

0.25

6 h

1 / 2/ 1 / 1

1.25

0 / 0 / 0 / 0

0

2 / 0 / 0 / 1

0.75

24 h

1 / 1 / 1 / 1

1.00

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

48 h

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

72 h

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

0 / 0 / 0 / 0

0

Animal No. (from left to right) 790, 796, 798, 799

Reactions on the cornea and iris were not observed. The conjunctival reactions were slight and disappeared totally within 48 hours. Palmitic acid is not irritating to eyes / mucosa under the test conditions.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
Conclusions:
CLP: not classified
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
29 Apr 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
The test item was applied to the chorioallantoic membrane (CAM) of a fertilized hen´s egg for 5 minutes. Afterwards, the CAM was evaluated for the development of lysis, hemorrhage, and coagulation to evaluate eye irritation.
GLP compliance:
yes
Species:
other: chicken egg
Strain:
other: White Leghorn
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Horst Geflügelzucht, Leverkusen, Germany
- Age at study initiation: 10 days
- Housing: The eggs were kept in an incubator before study inititation.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.6 ± 0.5 °C
- Humidity (%): ca. 50 - 60%


Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 µl


Duration of treatment / exposure:
5 min
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
Initial test: 3 fertilized eggs
Main study: 6 fertilized eggs
Details on study design:
TEST SYSTEM: HET-CAM (Hen´s egg test-chorioallantoic membrane): Fertilized eggs are incubated for 9 days. On the 10th day, the eggshield is opened and the chorioallantoic membrane is exposed to the test item.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The CAM was rinsed with physiological saline solution.
- Time after start of exposure: 5 min

SCORING SYSTEM: The scoring system differentiates between light, moderate and severe effects which are allocated in accordance to the reactions after exposure to the reference substance Texapon ASV in the concentrations of 0.5, 1 and 5%.

Irritation parameter:
other: hemorrhage
Remarks:
mean out of all 9 eggs
Run / experiment:
5 min
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No signs of hemorrhage were observed.
Irritation parameter:
other: coagulation
Remarks:
mean out of all 9 eggs
Run / experiment:
5 min
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No coagulation was observed.
Irritation parameter:
other: lysis
Remarks:
mean out of all 9 eggs
Run / experiment:
5 min
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No signs of hyperemia were observed.
Other effects / acceptance of results:
The test item did not induce hemorrhage, coagulation or lysis. Therefore, Aversin KFC is considered to be not irritating.
Interpretation of results:
other: not irritating
Conclusions:
Data are conclusive but not sufficient for classification.
Executive summary:

Regarding the CLP guidance document, negative results of the HET-CAM are not conclusive for a non-classification.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

Due to the lack of reliable data with fatty acids C16-18 on skin irritation, studies with two of the main constituents, C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid), are used for hazard assessment. Since fatty acids C16-18, palmitic acid, and stearic acid belong to the same category based on structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

Skin irritation by palmitic acid was evaluated in a study performed under GLP according to OECD guideline 404 with the exception, that the test was performed under occlusive condition (Kästner, 1988). Four Kleinrussen rabbits received an application of 0.5 g palmitic acid to the shaved skin under occlusion for 4 hours. The readings 24, 48, and 72 hours after application did not reveal any signs of irritation, thus resulting in mean scores of 0 for erythema and edema, respectively. As a consequence, test was cancelled due to welfare reasons. Based on the results, palmitic acid can be regarded as not irritating to skin.

In a study with human subjects, palmitic acid and 19 other substances were investigated with a closed epicutanous test. 10 µl of palmitic acid at a concentration of 50% was applied to the back of the volunteers for 24 hours using a Large Finn Chamber (Matthies, 1988). The reactions were scored for edema, erythema, scaling and fissures 1, 6, 24, 48, 72 and 144 hours after application. As result, for all readings the score 0 was found.

Skin irritation by stearic acid was evaluated in a study performed in accordance with federal guidelines (International Bio-Research, 1974). 0.5 mL of stearic acid was applied to the abraded skin of 6 New Zealand White rabbits under occlusion for 24 hours.at 24 and 72 hours after application revealed no signs of irritation. Although a longer application under occlusion than suggested according to actual guidelines, the resulting scores are 0, both for erythema and edema, respectively. Based on this, stearic acid can be regarded as not irritating to skin.

 

 

Eye

Due to the lack of reliable data with fatty acids C16-18 on eye irritation, studies with two of the main constituents, C16 fatty acid (palmitic acid) and C18 fatty acid (stearic acid), are used for hazard assessment. Since fatty acids C16-18, palmitic acid, and stearic acid belong to the same category based on structural and toxicological properties, this approach can be regarded as scientifically justified. Thus, read-across is performed based on a category approach (for details refer to IUCLID chapter 13).

Eye irritation by palmitic acid was analyzed in a study performed in accordance with GLP and according to OECD guideline 405 (Kästner, 1988). 0.1 g of palmitic was instilled into the rtights eyes of four Kleinrussen rabbits while the untreated left eyes served as control. The reactions were examined 1, 6, 24, 48, and 72 hour after administration and resulted in mean scores of 0, 0, 0.3, 0 and 0 for corneal opacity, iris, conjunctival redness and chemosis, and exudation, respectively. Since all signs were subsided on day three after instillation, the study was cancelled on that day due to animal welfare reasons. Based on the findings, palmitic acid can be regarded as not irritating to eyes.

In a published study performed according to national guidelines, stearic acid was instilled into the eyes of six rabbits (Briggs et al., 1976). Mild conjunctival erythema was found in 2 animals at 24 and 48 hours while all signs of irritation hat subsided completely in 72 hours. Thus, a mean score of 0.2 for conjunctival erythema could be calculated. Based on the results, stearic acid can be regarded as not irritating to eyes.

Justification for classification or non-classification

The substance may contain lauric acid (C12), which is classified as eye damage Cat 1. The specific concentration limit for the lauric acid is established as 73.6% based on reliable experimental data. According to CLP (1272/2008/EC) classification criteria for irritation/corrosion, fatty acids C16 -18 do not fulfill the criteria for classification and thus a non-classification is warranted for this endpoint, as the concentration of C12 is lower than 73.6%.