Registration Dossier

Administrative data

Description of key information

Valid in vivo studies in rabbits for skin irritation/corrosion and for eye irritation are available.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR
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.
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
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).
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).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.
GLP compliance:
no
Specific details on test material used for the study:
Acilanbrillantblau FFR 200% = Special Brilliant Blue FFR
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
White New Zealand rabbits (3-4 kg) of both sexes, individual housing.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
7 days (eyes were not washed).
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2 animals
Details on study design:
A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.16
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours), conjunctiva score was 2 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.
Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified.
Executive summary:

A single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days. Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.

Based on the conjunctiva score of 2 (24, 48 and 72 hours) a classification as Category 2 (irritating to eyes) based on GHS criteria is justified.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In the skin irritation/corrosion study no signs of skin irritation (score = 0) could be detected in any of the test animals, either at the end of the 24-hour application period or 48 hours later.

In the eye irritation study a single dose of 50 mg was applied into the conjunctival sac of 2 rabbits. Post observation time was 7 days. Cornea score was 0 at 24, 48 and 72 hours. Iris score was 0.16 (24, 48 and 72 hours) and chemosis score was 0.83 (24, 48 and 72 hours). The conjunctiva score was 2 (24, 48 and 72 hours). All effects were reversible within 7 days or earlier.

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Category 2 (irritating to eyes) is justified based on the conjunctiva score of 2 (24, 48 and 72 hours).