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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Equivalent to OECD 404. No GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(no data recorded on body weights, the exposure period was 24 hours instead of 4 h, the applied amount of the test substance was lower than that recommended in the guidelines)
Principles of method if other than guideline:
Modification of the method described by Draize (1944).
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
EC Number:
309-913-1
EC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides
Cas Number:
101357-16-8
Molecular formula:
Not applicable. Multiconstituent substance.
IUPAC Name:
Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides

Test animals

Species:
rabbit
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: approx. 3 kg
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A solution of 0.4 g/ml of the test substance in distilled water was prepared. 0.5 ml of this solution were applied to the animals.
Duration of treatment / exposure:
24 hours
Observation period:
24, 48 and 72 hours
Number of animals:
Three males
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: sterile gauze and wax paper.

SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beefy redness) to eschar formation 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0.3
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the available results, the test substance is not classified as skin irritating.
Executive summary:

The test item was applied only once to the shaved skin of three animals. The exposure lasted 24 hours. Observations of the treated skin were performed at 24, 48 and 72 hours after the end of the exposure. Based on the available results, the test substance is not classified as skin irritating.