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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: study well documented

Data source

Reference
Reference Type:
publication
Title:
Sensitizing potential of 14 mono (meth) acrylates in the guinea pig
Author:
Van der Walle HB, Klecak G, Geleick H, Bensink T
Year:
1982
Bibliographic source:
Contact Dermatitis: 8, 223-235

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Freund´s Complete Adjuvant
Concentration / amount:
0.5 M
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information