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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:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 8 day observation period
Qualifier:
according to
Guideline:
other: according to Fed. Reg. 38, No. 187, § 1500 42, p 27019 of Sept. 27, 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 654
- Physical state: yellow liquid
- Expiration date of the lot/batch: Oct. 1983

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Acclimatization period: app. 8days
One animal per cage (stainless steel with wire mesh walk floor; floor area: 40 cm x 51 cm).
Source: Gaukler, Offenbach/Main, FRG
Average weight: males: 2.61kg, females: 2.81kg
Room temperature: 20 - 26°C
Relative humidity: conventionally (about 30 - 70%)
Day/night rhythm: 12 h/12 h (6.00 - 18.00 hours/18.00 - 6.00 hours)
Diet: Ovator Solikanin 4 mm; Muskator-Werke Düsseldorf, FRG (about 130 g per animal daily);
drinking water about 250 ml per animal daily - fully demineralized water (Monday - Friday) - tap water (Saturday/Sunday).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
Application site: Conjunctival sac of the right eyelid
Readings: 1 h, 24 h, 48 h, 72 h, and 8 d after instillation
Assessment according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.05
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 1-5
Time point:
24/48/72 h
Score:
>= 0.3 - <= 1.3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.1
Max. score:
4
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material failed to induce significant eye irritation under the conditions of the test.