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Registration Dossier
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EC number: 939-654-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1977
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in humans at low %. Although it was not done according to current standard methods, it is considered to be relevant for weight of evidence, however less adequate for classification.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: A.M. Kligman and W. Wooding: A method for the measurement and evaluation of irritants on human skin. J. Invest. Derm. 49:1967
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite
- EC Number:
- 939-654-5
- Molecular formula:
- Molecular formula cannot be given as the substance is a mixture
- IUPAC Name:
- Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- human
- Details on test animals or test system and environmental conditions:
- Not applicable
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: normal skin, no preparation
- Controls:
- not required
- Amount / concentration applied:
- - Concentration (if solution): 1, 5 and 10% concentrations of [Trade name]
- Duration of treatment / exposure:
- 10 days
- Observation period:
- 10 days (during exposure)
- Number of animals:
- 10
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- 1% of test item
- Basis:
- mean
- Time point:
- other: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 days
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- 1% of [Trade name] produced no visible reaction in any of the subjects. By the 6th day, some individuals treated with 5% exhibited mild erythema which gradually worsened thereafter. The results from the 10% solution were similar to the 5% solution.
Any other information on results incl. tables
Table 1. [Trade name] 5% Concentration on Normal Skin
Subject No. |
Days |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
2 |
2 |
4 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
2 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
9 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
2 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
0= no reaction
1= mild erythema
2= moderate erythema
3= intense erythema and edema
Table 2. [Trade name] 10% Concentration on Normal Skin
Subject No. |
Days |
|||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
3 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
1 |
2 |
2 |
4 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
2 |
5 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
6 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
2 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
2 |
2 |
9 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
2 |
10 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
2 |
2 |
0= no reaction
1= mild erythema
2= moderate erythema
3= intense erythema and edema
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- Five and ten percent test item were mildly irritating when applied under continuous occlusion on normal skin. The latter mode of exposure is, of course, greatly exaggerated in relation to normal use.
- Executive summary:
The 10-day occlusive patch test method was used as follows: 1, 5 and 10% concentrations of the test item were applied daily to the forearms of 10 young-adult female college students. 1% of the test item produced no visible reaction in any of the subjects. By the sixth day, some of the volunteers treated with 5% of the test item began to exhibit mild erythema which gradually worsened thereafter. The results with 10% were indistinguishable from the 5% concentration. 5 and 10% test item are mildly irritating when applied under continuous occlusion. The latter mode of exposure is, of course, greatly exaggerated in relation to normal use.
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