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EC number: 306-082-7 | CAS number: 95912-86-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 18 Mar 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. The exposure was performed under occlusive conditions, the analytical purity of the test substance was not specified.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive exposure
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Fatty acids, C8-10, C12-18-alkyl esters
- EC Number:
- 306-082-7
- EC Name:
- Fatty acids, C8-10, C12-18-alkyl esters
- Cas Number:
- 95912-86-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C8-10, C12-18 (even numbered)-alkyl esters
- Details on test material:
- - Name of test material (as cited in study report): coco caprylate/caprate
- Analytical purity: no data
- Physical state: clear liquid
- Lot/batch No.: 0907 D
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated skin site of the same animal served as the control
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
Reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated site was not washed after patch removal
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibilty not applicable
- Irritant / corrosive response data:
- 1 hour after exposure, all the animals had slight to well-defined erythema, while 2/3 had very slight to slight edema. These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema and slight edema. the edema persisted until the 48-hour reading time point.All skin irritation effects had cleared completely within 72 hours after the exposure ended.
Any other information on results incl. tables
Table 1: Erythema and edema scores for skin irritation of the individual animals at different reading time points:
Observation time |
Rabbit no. |
|||||
1 |
2 |
3 |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 h |
2 |
2 |
1 |
0 |
1 |
1 |
24 h |
1 |
2 |
0 |
0 |
0 |
0 |
48 h |
0 |
1 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h |
0.33 |
1.00 |
0 |
0 |
0 |
0 |
Mean value 24 + 48 + 72 h all animals |
0.11 |
0.33 |
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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