Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
A dose of 100 µl ( = ca. 32 mg) was placed into the conjunctival sac of one eye of 3 female adult New Zealand White rabbits (3-4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with normal saline. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of ocular reaction was recorded until day 7 according to Draize
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Pigment Yellow FC 26290; BALK-No.; 92/026-N

Test animals / tissue source

Species:
rabbit
Strain:
other: HC:NZW

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 female animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, score = 0 at any time point
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable, score = 0 at any time point
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible within: 7 days

Any other information on results incl. tables

Exposure of the test substance to the eye caused reactions of the mucous membranes and a discharge in all 3 animals. Signs proved to be fully reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

A dose of 100 µl was placed into the conjunctival sac of one eye of 3 female adult New Zealand White rabbits (3-4 kg) for an exposure period of 24 hours. Then the treated eyes were rinsed with normal saline. The contralateral eye remained untreated and served as a control. The eyes were examined and the grade of ocular reaction was recorded until day 7 according to Draize.

Exposure of the test substance to the eye caused reactions of the mucous membranes and a discharge in all 3 animals. Signs proved to be fully reversible within 7 days.

The findings indicates that the product may be considered as slight irritating to the eyes, but a classification is not justified.