Registration Dossier
Registration Dossier
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EC number: 931-434-7 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (non-GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 6 animals used, no analytical purity of test substance reported, only readings at 24 and 72 hours
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan stearate
- EC Number:
- 215-664-9
- EC Name:
- Sorbitan stearate
- Cas Number:
- 1338-41-6
- Molecular formula:
- C24H46O6
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped/abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance was applied to each test site. - Duration of treatment / exposure:
- 4 h
- Observation period:
- observation after 4, 24, and 72 h
- Number of animals:
- 6 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: Two test sides located lateral to the midline of the back (approx. 10 cm apart) were selected. One of the two sites was abraded, while the other test site remained intact.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean of readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: intact skin, 48 h-value extrapolated from 24 h-value
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean of readings at
- Time point:
- other: 24,48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: no data
- Remarks on result:
- other: intact skin, 48 h-value extrapolated from 24 h-value
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of the remaining 4 animals and mean of readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin, 48 h-value extrapolated from 24 h-value
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals and mean of readings at
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: intact skin, 48 h-value extrapolated from 24 h-value
Any other information on results incl. tables
Table 1: Irritation Scores, abraded skin
Animal # |
4 h |
24 h |
48 h* |
72 h |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
6 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*No 48 h values were obtained in the study. The 48 h-values are extrapolated from the 24 h-value (worst case) for the calculation of the mean values relevant for classification.
Table 2: Irritation Scores, intact skin
Animal # |
4 h |
24 h |
48 h* |
72 h |
||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
4 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
6 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*No 48 h values were obtained in the study. The 48 h-values are extrapolated from the 24 h-value (worst case) for the calculation of the mean values relevant for classification.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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