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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:
24.8.1982-27.8.1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hylyne Rabbits Ltd., Marston, Northwich, Cheshire
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.26-2.85kg
- Housing: individual housing in suspended cages
- Diet: standard laboratory diet, ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 +/- 2.5
- Humidity (%): humidity was not controlled but remained within a range of 68-70%RH
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
Assessment of damage/irritation was made 1, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Draize 1959

TOOL USED TO ASSESS SCORE: UV light, opthalmoscope, fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.1
Max. score:
3
Remarks on result:
other: (redness)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The test material produced no evidence of positive ocular irritation in any rabbit. A dulling of the normal lustre of the cornea was observed in one rabbit at the one hour reading only. Mild conjunctival inflammation, with or without slight swelling was observed in all three rabbits at this reading. The reactions had ameliorated completely in two rabbits by the 48 hours reading. Mild conjunctival inflammation only was seen in the remaining rabbit until the 48 hour observation.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to the rabbit eye in a test carried out according to the appropriate OECD guideline, compliant with GLP.