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Toxicological information

Skin irritation / corrosion

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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:
1977
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

Constituent 1
Chemical structure
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

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.