Registration Dossier

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: scientifically acceptable and sufficient documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
Two rabbits were applied 500 µl of the test substance (Acilanbrillantblau FFR 200%) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 24 hours the skin areas were washed with water and soap/plant oil. Post observation period was 7 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
White New Zealand rabbits (3-4 kg) of both sexes, individual housing.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 and 48 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 and 48 hours
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritant / corrosive response data:
Acilanbrillantblau FFR 200% was not irritating (score = 0 at 0 and 48 hours).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Acilanbrillantblau FFR 200% was not irritating (score = 0 at 0 and 48 hours).
Executive summary:

Two rabbits were applied 500 µl of the test substance (Acilanbrillantblau FFR 200%) at the inner side of one of the ears. The test material was fixed by an adhesive bandage for 24 hours. After 24 hours the skin areas were washed with water and plant oil. Post observation period was 7 days. Acilanbrillantblau FFR 200% was not irritating (score = 0 at 0 and 48 hours).