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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
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (purity not reported)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Fed. Reg. 38 No. 187 §1500.42
Deviations:
yes
Remarks:
3 animals were rinsed after 30 s, 3 were not rinsed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: solid
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG, CH; ad lib.
- Water (e.g. ad libitum): unspecified; ad lib.
- Acclimation period:

ENVIRONMENTAL CONDITIONS
not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
3 animals: without rinsing
3 animals: rinsed after 30 s
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
in total 6
Details on study design:
REMOVAL OF TEST SUBSTANCE
3 animals: without rinsing
3 animals: rinsed after 30 s

SCORING SYSTEM: OECD Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
6 animals (rinsed or not rinsed)
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Remarks:
6 animals (rinsed or not rinsed)
Time point:
other: 24 - 48 -72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
6 animals (rinsed or not rinsed)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects

Any other information on results incl. tables

Criteria for the valuation of chemosis and discharge effects were given in the report, but no detailed results were presented. It is assumed that the parameter "conjunctivae" covers conjunctivae redness and chemosis in combination.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information