Registration Dossier

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:
1995-05-30 until 1995-06-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Scientifically reliable study, similar to current OECD guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EPA OPP 81-4 (Acute Eye Irritation)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Froxfield (U.K.) Ltd., Petersfield, Hampshire. England
- Age at study initiation: 11 - 14 weeks
- Weight at study initiation: 2.5 to 3.4 kg
- Housing: housed individually in metal cages with perforated floors
- Diet: a standard laboratory diet SDS Stanrab (P) Rabbit, ad libitum
- Water: drinking water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 19°C
- Humidity: 30 - 70 %
- Air changes: approximately 19 air changes per hour
- Photoperiod: 12 hours of artificial light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated as a control
Amount / concentration applied:
50 mg of the test substance
Duration of treatment / exposure:
Until end of the observation period
Observation period (in vivo):
1, 2, 3, 24, 48, 72 hours and 4 and 7 days after instillation
Number of animals or in vitro replicates:
7 rabbits
Details on study design:
SCORING SYSTEM: Draize scoring

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0.06
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(mean scores of animals 1-6)
Time point:
other: 24, 48, 72 hours
Score:
0.05
Max. score:
4
Reversibility:
fully reversible within: 48 hours

Any other information on results incl. tables

One animal was not considered in the results/scores presented above (results of 6 animals presented instead of 7) as the animal was not treated as the rest of the animals (pre test). The treated eye of this animal was washed, in opposite to the other treated eyes of the other animals. No irritation/ corrosion effects were observed in the washed eye of this animal.

Applicant's summary and conclusion

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