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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:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): DM-8121

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand
Details on test animals or tissues and environmental conditions:
NDA

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye served as a control.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
2 seconds
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Nine males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): luke-warm water
- Time after start of exposure: three animals after two seconds; three animals after four seconds and three animals unwashed

SCORING SYSTEM: Draize (1956)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Score was the same for all rabbits at all time points.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: scores were the same for all rabbits at all time points
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
3
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scores were the same for all rabbits at all time points
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48 and 72 hours
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scores were the same for all rabbits at all time points
Irritant / corrosive response data:
The group mean score at 24 hours was 110/110. The group mean scores at 48 and 72 hours were 110/110. The Draize evaluation does not provide for the observation of hemorrhage which was noted in this test. One rabbit from each group was selected for autopsy following the 72 hour reading. Complete enucleation of the eye was noted in each animal examined.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dimethyltin dichloride was found to be a severe eye irritant.
Executive summary:

Dimethyltin dichloride was tested for eye irritation according to the method of Draize using albino rabbits. This method was similar to that detailed in the OECD 405 guideline.

9 male New Zealand rabbits were used. 100 mg of test substance was placed into the right eye of the rabbit, whilst the left eye served as a control.

The group mean score at 24 hours was 110/110. The group mean scores at 48 and 72 hours were 110/110. Complete enucleation of the eye was noted in each animal examined.

Dimethyltin dichloride was found to be a severe eye irritant.