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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study (OECD TG 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
RALOX 46, batch number: 95041

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
once
Observation period (in vivo):
up to 72 h
Number of animals or in vitro replicates:
3 (1 male, 2 females)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: mean: animals and time points
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: mean: animals and time points
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 48 h
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: conjunctival redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: no effects

Any other information on results incl. tables

Residual test material was noted around all treated eyes during the study.

No corneal effects were noted during the study.

Iridial inflammation was noted in two treated eyes at the 1 -hour observation.

Minimal to moderate conjunctival irritation was noted in all treated eyes at the 1 -hour observation. Minimal irritation was apparent in two treated eyes at the 24 -hours observation. Treated eyes appeared normal 24 or 48 hours after treatment. No effects noted after 72 hours.

Maximum group mean score: of 14 1-hour after treatment (conjunctivae)

Maximum total score: 19 at 1 -hour after treatment (iris and conjunctivae) (remark: no effects on cornea)

The test material did not produce positive criteria in any rabbit according to EU labelling regulation.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not produce positive criteria in any rabbit according to EU labelling regulation.