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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No 187, §1500.42, p27019, 27 Sept 1973
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Initiator 554
- Analytical purity: >98%
- Physical state: crystalline
- Storage condition of test material: protected from light

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not reported
- Weight at study initiation: mean 2.60 kg for male, 2.94 for female
- Diet: Ssniff from the company INTERMAST, ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated left eye of the same animal
Amount / concentration applied:
TEST MATERIAL
Amount applied: 56 mg (corresponding to 0.1 ml bulk volume)
Duration of treatment / exposure:
test substance was not washed
Observation period (in vivo):
5 days
(observations after 24, 48, 72h, 5d)
Number of animals or in vitro replicates:
4 females and 2 males
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 test animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all test animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals #1,3,5,6
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: redness score was 2 in all test animals after 1 h
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals #2,4
Time point:
24/48/72 h
Score:
>= 0.6 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 72h
Remarks on result:
other: redness score was 2 in all test animals after 1 h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all test animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: chemosis score was 1 in all test animals after 1 h
Irritation parameter:
other: conjunctiva discharge
Basis:
mean
Remarks:
all test animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
other: conjunctiva discharge score was 2 in all test animals after 1 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information