Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation Basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: Only basic data given
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Weight at study initiation: 3556-4556 g

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): pure

Duration of treatment / exposure:
No Data
Observation period (in vivo):
3 d
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
2
Reversibility:
other: No effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
3
Reversibility:
other: No effects
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all three animals
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: No effects

Any other information on results incl. tables

No corneal or iridial effects were observed. Conjunctival effects included slight redness (one animal) and slight discharge (one animal) were transiently seen approx. one hour after dosing.

Applicant's summary and conclusion

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