Reaction products of 2-methylimidazole and 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the O.E.C.D. test guideline 405 with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

EC Number:

701-436-0

Molecular formula:

(C15H16O2.C4H6N2.C3H5ClO)x

IUPAC Name:

Reaction products of 2-methylimidazole and 2,2'-[(1- methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

As per IUCLID5 Sections 1.1. 1.2. 1.4. and 4.1.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy female New Zealand White rabbits were obtained from Froxfield Farms (UK) Limited, Froxfield, Hampshire. The animals were individually housed in grid bottomed metal cages. The rabbit room was air-conditioned with temperature maintained within the range 17-20°C and relative humidity within the range 39-56% during the acclimatisation and study periods. Fluorescent lighting was controlled to give an artificial cycle of 12 hours lightIl2 hours darkness per day. An antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diets Services, Witham, Essex) and mains drinking water via an automatic watering system were freely available. The rabbits were acclimated for at least five days before being placed on study.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 gm

Duration of treatment / exposure:

72 hr

Observation period (in vivo):

72 hr

Number of animals or in vitro replicates:

3

Details on study design:

A 0.1 gm aliquot of the powder test substance was administered to the right eye of each animal by gently pulling away the lower lid from the eyeball to form a cup into which the material was placed. The lids were then held shut for a few seconds and moved gently about to distribute the testsubstance around the surfaces of the eye and lids.

One, 24, 48 and 72 hours after dosing, the treated eyes were examined under a standard light source. Each eye was assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hr - 72 hr.

Remarks on result:

other: No evidence of eye irritation was observed in any of the rabbits.

Irritant / corrosive response data:

There was no apparent signs of irritation in the treated eye of any of the 3 rabbits at any of the examinations made during the 72 hour observation period.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Study report conclusion.

Conclusions:

The test substance is not irritating to the rabbit eye under the conditions of the study.

Executive summary:

The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was evaluated for eye irritation potential in an O.E.C.D. test guideline 405 study. The test substance was not irritating to the rabbit eye under the conditions of the study.