Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

Constituent 1
Chemical structure
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

Timea)

0.5%

1%

Test substance

6

28 days

0.4

1.1b)

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.