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Toxicological information

Skin sensitisation

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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

Reference
Name:
Unnamed
Type:
Constituent

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 group
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.