Registration Dossier

Toxicological information

Eye irritation

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Administrative data

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

Data source

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

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

Executive summary:

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