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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 specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was conducted prior to GLP as well as Guidelines; however, sufficient data is available for interpretation of study results.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1945
Report Date:
1945
Reference Type:
publication
Title:
Unnamed
Year:
1963
Reference Type:
publication
Title:
Unnamed
Year:
1946

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Neat material and diluted material was placed in the rabbit eye and observed for changes. The amount of neat material placed in the eye is less than current guidelines require but the effect observed makes this study relevant.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
epichlorohydrin

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Rabbits, number tested, strain, sex, age, source and weight at study initiation, unknown

Test system

Vehicle:
other: administered undiluted or as a 0.1% or 0.01% solution in water
Controls:
not specified
Amount / concentration applied:
0.001 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Scored at 24 hours post-dosing
Number of animals or in vitro replicates:
No data
Details on study design:
Examinations: Scoring system: as cited in Carpenter and Smyth, 1946; Tool Used to Assess Score: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hr
Score:
>= 4
Reversibility:
not specified
Remarks on result:
other: Score is based on Carpenter paper and is believed to be equivalent to a 3 using the EPA scale.
Irritant / corrosive response data:
In the rabbit eye, 0.001 ml produced severe necrosis. An excess of 0.1% solution in water also caused necrosis, but a 0.01% aqueous solution did not (as documented in original study report 8-28). Individual and total scores were not available in original study report 8-28. No data given as to reversibility.
Weil et al. (1963) published an injury grade of 4 out of a possible 10 (defined as: 0.02 ml undiluted gives injury of up to 5 points on a maximum scale of 20 points). This is inconsistent with the results cited in the original report.
Other effects:
No addtional information available.

Any other information on results incl. tables

Given the amount of test material applied to the rabbit eye is 1% of that required by current guidelines, the results are especially relevant.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Undiluted test material (0.001 ml) caused severe necrosis, 0.1% in water caused necrosis but 0.01% aqueous solution did not cause necrosis.

Executive summary:

In the rabbit eye, 0.001 ml produced severe necrosis, while an excess of a 0.1% solution in water caused necrosis but a 0.01% solution did not.