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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Red 0106-PP1
IUPAC Name:
Red 0106-PP1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
100 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 76
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 77
Time point:
24/48/72 h
Score:
1.67
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: 78
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 76
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: 77
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal: 78
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
animal: 76, 77, 78
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 76, 77, 78
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 7 days
Other effects:
COLORATION:
Slight to marked violet discoloration of the treated eye by the test article was noted in all animals up to 24 hours and persisted in one animal up to 48 hours.
Violet remnants were seen in the eye or conjunctival sac of all animals one hour after treatment and in one animal until day.

MORTALITY/CLINICAL SIGNS:
No mortality and no clinical signs observed.

Any other information on results incl. tables

The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 1.11 redness of the conjunctivas and grade 0.44 chemosis of the conjunctivae.

The instillation of RED 0106-PP1 into the eye resulted in mild, early-onset and transient ocular changes, such as slight watery discharge, swelling and reddening of the conjunctivae and sclerae. A violet colored staining was also present in the treated eye of all animals up to 48 hours after treatment. These effects were however reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. No corrosion was observed at any of the measuring intervals.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
Not eye irritant