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Registration Dossier
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EC number: 949-892-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1970s-1980s
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Esterification products of alcohols C12-13 linear and branched with lauric acid
- EC Number:
- 949-892-1
- IUPAC Name:
- Esterification products of alcohols C12-13 linear and branched with lauric acid
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- male, albino
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- two test sites left intact and two scarified
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 4 h, 24 h, 48 h, 72h, 7 d
- Number of animals:
- 6 albino male rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.17
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.83
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.17
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.33
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The irritation index in rabbits exposed to esterification products of alcohols C12-13 linear and branched with lauric acid was 0.305. The conclusion is that the test substance can be considered non-irritant under the conditions of this study.
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