(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Contact sensitivity to acrylate compounds in guinea pigs

Author:

Parker D, Turk JL

Year:

1983

Bibliographic source:

Contact Dermatitis 9: 55-60

Materials and methods

GLP compliance:

no

Type of study:

other: Contact skin reactions in guinea pigs immunized by the Polak method

Justification for non-LLNA method:

At the time of the study, the LLNA method has not been established.

Test material

Test material information

Constituent 1

Reference substance name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

EC Number:

256-032-2

EC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

Cas Number:

42978-66-5

Molecular formula:

C15 H24 O6

IUPAC Name:

(1-methyl-1,2-ethanediyl)bis[oxy(methyl-2,1-ethanediyl)] diacrylate

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Royal College of Surgeons or David Hall, Newchurch, Staffordshire, England
- Weight at study initiation: 400-500 g
- Diet (e.g. ad libitum): Labsure RGP diet liberally supplemented with cabbage and hay

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal

Vehicle:

other: ethanol:saline 1:4 or acetone:olive oil 4:1

Challenge

Route:

epicutaneous, open

Vehicle:

other: ethanol:saline 1:4 or acetone:olive oil 4:1

No. of animals per dose:

6 animals were used in total

Results and discussion

In vivo (non-LLNA)

Results

Reading:

other: Time of first positive skin test

Group:

test chemical

Dose level:

0.5%, 1%

Total no. in group:

6

Remarks on result:

other: Results are expressed as the average intensity of the skin reactions at a certain skin test concentration, of all the animals .

Any other information on results incl. tables

The skin test concentrations were 0.5% and 1%. The first positive skin test was observed after 28 days. The test substance was judged to be a weak sensitizer.

			Skin test concentrations
Compound	No. of animals	Time^a)	0.5%	1%
Test substance	6	28 days	0.4	1.1^b)

a)    Time of first positive skin test

b)    Results are expressed as the average intensity of the skin reactions at a certain skin test concentration, of all the animals .

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Based on the study results the test substance is a skin sensitizer Cat. 1.

Executive summary:

In this non GLP study, contact skin reactions were investigated using guinea-pigs that were immunized by the Polak method (1983a). On day 7, the animals received 4 footpad injections of 0.1 ml of an emulsion containing 2 mg/ml of the chemical, in ethanol:saline (1:4), in Freund's complete adjuvant (FCA - Difco mycobacterium butyricum). In addition, 0.1 ml of the emulsion was injected into the nape of the neck . The guinea pigs received a total of 1 mg of chemical. On day 7, open skin testing was performed by dropping 0.02 ml of a solution of the chemical in acetone:olive oil (4:1) onto the shaved flank. The concentration of the skin test solution varied with the chemical and those used were dilutions of 5% or the maximum concentration which gave no non-specific irritation. Skin tests were repeated weekly at different sites on the flank for up to 12 weeks. The skin test concentrations were 0.4% and 1.1%. The first positive skin test was observed after 28 days. The test substance was judged to be a weak sensitizer.