Registration Dossier

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Administrative data

Description of key information

C.I. Direct Blue 264 is not irritating to the skin and has only slight effects on the eye.

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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted protocol; no GPL; conducted in 1976
Qualifier:
no guideline followed
Principles of method if other than guideline:
Compound was delivered to the inner-ear skin of 2 rabbits for 24 hours.
Dose: 500 mg/animal
semiocclusive treatment; compound fixed with an adhesive bandage for 24 hours; animals were observed for 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Type of coverage:
semiocclusive
Preparation of test site:
other: inner-ear skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs.
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs..
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs.
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0 at 24 and 48 hrs.
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
>= 0
Max. score:
4
Reversibility:
other: not measured/tested
Remarks on result:
not measured/tested

No irritation observed at any time point: 0, 24 and 48 h.

Interpretation of results:
GHS criteria not met
Conclusions:
No irritation observed at any time point: 0, 24 and 48 h.
Executive summary:

No irritation observed at any time point: 0, 24 and 48 h.

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
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted protocol; no GPL; conducted in 1976
Qualifier:
no guideline followed
Principles of method if other than guideline:
2 rabbits were used
50 mg/compound per eye
observation time 7 days.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
eyes are not washed
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
2.16
Max. score:
3
Reversibility:
other: see remarks on results
Remarks on result:
other: In one animal the conjunctive score was 0 after 7 days, the other animal revealed a score of 1 after 7 days. No data for later time points are available.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.16
Max. score:
4
Reversibility:
fully reversible
Executive summary:

C.I. Direct Blue 264 has only slight effects and is overall not irritating according to DSD or GHS.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are limited but valid data available to evaluate potential effects on skin or eye irritation. In these early studies no effect on skin irritation was observed in 2 rabbits after application to the inner ear. In an eye irritation study no effect on cornea or iris was observed in an early study in two rabbits after 24, 48 and/or 72 hours and only slight effects on conjunctivae and chemosis. All effects were reversible.

Justification for classification or non-classification

C.I. Direct Blue 264 is not irritating to the skin and has only slight effects on the eye. Thus C.I. Direct Blue 264 is considered as "not irritating" according to GHS or DSD.