1-chloro-2,3-epoxypropane

Eye irritation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1945

Report date:

1945

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1963

Reference 3

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

Test material information

Constituent 1

Reference substance name:

1-chloro-2,3-epoxypropane

EC Number:

203-439-8

EC Name:

1-chloro-2,3-epoxypropane

Cas Number:

106-89-8

Molecular formula:

C3H5ClO

IUPAC Name:

2-(chloromethyl)oxirane

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:

24 h

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:

Category 1 (irreversible effects on the eye) based on GHS criteria

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.