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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Limited data given in the study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The albino rabbit was used. The substance was applied in a single dose to the skin of the animals (occlusive); one abraded and one non abraded area was used. The exposure period was 24 hours. The dose was 0.5ml. All animals were examined for signs of erythema and oedema 24 and 72 hours post-treatment. No data on the observation period.
GLP compliance:
no
Remarks:
The study was performed before the adoption of GLP.

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, dodecyl-, branched, compd. with 2-propanamine
EC Number:
290-709-3
EC Name:
Benzenesulfonic acid, dodecyl-, branched, compd. with 2-propanamine
Cas Number:
90218-35-2
IUPAC Name:
90218-35-2
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Witconate P1059 (data on the test material presented below were collected from an MSDS under the same trade name)
- Substance type: product
- Physical state: liquid
- Analytical purity: 90%
- Appearance: (25°C) Clear amber liquid at 25 C max
- Gardner: 0 - 7
- Moisture 4.0 - 5.0 %
- pH 20% in 25% IPA 4.5 - 5.5

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle used
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
24 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: no data
- % coverage: occlusive
- Type of wrap if used: cotton gauze, polyethylene film, a flannel cloth taped around the trunk of the animal

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 72 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 72 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 72 h
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean 24, 72 h
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean 24, 72 h
Score:
4
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean 24, 72 h
Score:
3.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean 24, 72 h
Score:
3
Max. score:
4
Reversibility:
no data
Remarks on result:
other: unabraded and abraded skin
Irritant / corrosive response data:
The results indicate skin irritation. No further information available.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, Witconate P1059 is irritating to the skin of rabbits.
Executive summary:

The skin irritation potential of Witconate P1059 (Benzenesulfonic acid, dodecyl-, branched, compd. with 2-propanamine, CAS No 90218-35-2) was tested on six male albino rabbits. Prior to exposure the hair was clippedfrom the abdomen of the animals; two areas of the abdomen were designated for application of the patches (one abraded and one unabraded). The test sample (0.5 ml) was placed on the skin under a small square of cotton gauze and maintained in contact with the skin under a larger square of polyethylene film and anchored to the skin with strips of adhesive tape. A square of flannel cloth was then taped around the trunk of the animal to further protect the patches from being dislodged. After 24 hours the vest and patches were removed and the skin examined for signs of irritation (erythema and/or edema). Examination was made again after 72 hours. Erythema irritation scores were between≥ 2.3 - ≤ 4.0 for all animals, and edema scores werebetween≥ 2.3 - ≤ 4.0 for the majority of the anilas tested.

Based on this result Witconate P1059 is irritating to the skin (Skin Irrit. 2, H315 Causes skin irritation) of the rabbit.