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

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Healthy female New Zealand White rabbits were obtained from Froxfield Farms (UK) Limited, Froxfield, Hampshire. The rabbits were individually housed in grid bottomed metal cages. An antibiotic free rabbit diet (SQC Standard rabbit pellets produced by Special Diet Services, Witham, Essex) and mains drinking water via an automatic watering system were freely available.

The rabbit holding room was air conditioned with temperature in the range 10-20°C and relative humidity in the range 47-65% during the acelimatisation and study periods. The room was illuminated by fluorescent lighting which was controlled to give an artificial cycle of 12 hours light l2 hours darkness per day. The aAnimals were allowed an acclimatisation period of at least 5 days before being placed on study. .

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 gram.

Duration of treatment / exposure:

4 hr

Observation period:

72 hr

Number of animals:

3

Details on study design:

The day before dosing, the dorsal surfaces of the trunk of the rabbits with healthy skin was clipped free of hair using an Oster Model A2 clipper with Angra blade. The following day, the animalr were placed in a restraining stock and a 0.5gm aliquot of the test substance , moistened with water, was placed evenly over a 2.5cm. square of surgical lint which was then applied to the skin site, on the flank and caudal to the last rib, so that the test substance was in contact with the skin. This test patch was held in position by encircling the trunk of the animals with a length of ‘Elastoplast’ elastic adhesive bandage. The animals were then returned to their cages. After 4 hours the bandages were removed and the treated area gently cleaned using cotton wool soaked in warm water. One hour after the removal of the patches and test substance, the treated sites were assessed for signs of reaction to treatment. Similar examinations were made 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1, 24, 48 and 72 hr post exposure.

Score:

ca. 0.3

Reversibility:

fully reversible

Remarks on result:

other: One animal had an erythemia score of 0.3 that was reversible within 48 hr.

Irritant / corrosive response data:

There was little or no evidence of skin irritation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The test substance was non-rritating to rabbit skin under the conditions of the study.

Executive summary:

The test substance, Bisphenol A, epichlorohydrin polymer, 2-methylimidazole condensate, was evaluated for potential skin irritation by an O.E.C.D. test guideline 404 rabbit study. There was little or no evidence of skin irritation observed in the study. Therefore, the test substance was non-rritating to rabbit skin under the conditions of the study.