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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to scientifically accepted method; old study with limited documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not applicable
Remarks:
Study conducted 1974; limited documentation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Flectol H; purity not indicated

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72. 120, 168 h
Number of animals or in vitro replicates:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72, 120, 168 h
Score:
0
Max. score:
80
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72, 120, 168 h
Score:
0
Max. score:
10
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 h
Score:
5
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
4
Max. score:
20
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48, 72, 120, 168
Score:
0
Max. score:
20
Reversibility:
fully reversible
Other effects:
Immediate after dosing to 10 min after dosing: slight discomfort; 1 h after dosing moderate discharge; 24 h after dosing slight discomfort; 48 h and later-timepoints: all scored zero

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test compound was not irritating to the skin in an study equivalent to OECD TG 405 with 6 rabbits dosed with 100 mg TMQ.