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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study well documented
Principles of method if other than guideline:
GPMT according to Klecak 1977 and Klecak and Geleick 1977
GLP compliance:
not specified
Type of study:
Freund's complete adjuvant test
Species:
guinea pig
Strain:
other: Himalayan white spotted outbred strain and Dunkin-Hartley outbred strain
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Himalayan white spotted outbred strain: Inst. for Biomedical Research, Füllinsdorf, CH; Dunkin-Hartley outbred strain: Olac Ltd., Bicester, GB
- Weight at study initiation: 350 - 450 g
- Housing: in pairs
- Diet (e.g. ad libitum): pellet diet containing vitamin C
Route:
intradermal
Vehicle:
other: Freund´s Complete Adjuvant
Concentration / amount:
0.5 M
Route:
epicutaneous, open
Vehicle:
other: Freund´s Complete Adjuvant
Concentration / amount:
0.5 M
No. of animals per dose:
8 (control 4-6)
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5 times 0.1 mL on d0, d2, d4, d7 and d9

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: d21 and d35
- Evaluation (hr after challenge): readings after 24 and 48 h
Reading:
other: 1st challange after 21 d
Group:
test group
Dose level:
0.5 M , 0.1 ml
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: other: 1st challange after 21 d. Group: test group. Dose level: 0.5 M , 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Reading:
other: 2nd challange after 35 d
Group:
test group
Dose level:
0.5 M , 0.1 ml
No. with + reactions:
0
Total no. in group:
8
Clinical observations:
no data
Remarks on result:
other: Reading: other: 2nd challange after 35 d. Group: test group. Dose level: 0.5 M , 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 8.0. Clinical observations: no data.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A publication is available which asesses the potential of the test substance to induce delayed contact hypersensitivity was assessed using the guinea pig maximization test (GPMT) based on the method of Magnusson and Kligman in a non-GLP conform study and in the Freund's complete adjuvant test (FCAT) (van der Walle et al., 1982).

The concentrations of the test substance suitable for use in the main experiment were determined in a pretest. The minimum irritant concentration was determined in FCA pretreated animals. The maximum non-irritant concentration also was determined. The used vehicle was Aramek (oleum arachidis/methylethylketone). The intradermal induction was carried out with 0.5 M test substance on day 0 and epicutaneous induction with 1 M (the concentration giving a slight to moderate irritation) on day 7. The challenge was performed on day 21 and day 35 thereafter. The highest concentration tested was the maximum non-irritating concentration. The results were graded according to the classification of Magnusson & Kligman. Both challenges exhibited no positive reactions (0/10 animals). The FCAT was carried out with eight animals in parallel which also showed no sensitising effects (0/8 animals).

 Based on the results of this study it was concluded that t-butyl methacrylate does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen.


Migrated from Short description of key information:
The test item did not have a sensitising effect on the skin of guinea pigs in the Guinea Pig Maximisation Test.

Justification for selection of skin sensitisation endpoint:
Most suitable study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, the test substance is not classified as a skin sensitiser according to the criteria of Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP).