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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:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
GPMT test already available (conducted in 1991)
Test material information:
Composition 1
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd. (Bicester, Oxfordshire, England)
- Age at study initiation: ca. 4 weeks
- Weight at study initiation: 224-265 g
- Housing: groups of 5 in stainless steel cages
- Diet (e.g. ad libitum): ad libitum (certified diet)
- Water (e.g. ad libitum): ad libitum (analyzed by local water authiorities)
- Acclimation period: 11 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C (15-23 °C)
- Humidity (%): 55% (40-70%)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction:
Intradermal: 0.1 ml 30 % v/v RAPI Cure CHVE in paraffin oil
Dermal: 10 % Sodium lauryl sulphate on day 7 to make the skin more susceptible and 100 % Rapi-cure on day 8

Challenge: 100 % and 30 % v/v RAPI Cure CHVE in paraffin oil
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction:
Intradermal: 0.1 ml 30 % v/v RAPI Cure CHVE in paraffin oil
Dermal: 10 % Sodium lauryl sulphate on day 7 to make the skin more susceptible and 100 % Rapi-cure on day 8

Challenge: 100 % and 30 % v/v RAPI Cure CHVE in paraffin oil
No. of animals per dose:
20
Details on study design:
RANGE FINDING TESTS:
intra dermal
50, 30, 10, 5, 3 % Rapi-cure CHVE in Paraffin oil and
50, 30, 10, 5, 1 % Rapi-cure CHVE in paraffin oil + FCA
dermal
100 , 50, 30, 10 % Rapi-cure CHVE in Paraffin oil

MAIN STUDY
- Test groups: 20 animals
- Control group: 20 animals

A. INDUCTION EXPOSURE
Intradermal: 0.1 ml 30 % v/v RAPI Cure CHVE in paraffin oil + FCA
Dermal : 10 % Sodium lauryl sulphate on day 7 to make the skin more susceptible and 100 % Rapi-cure on day 8

B. CHALLENGE EXPOSURE
- Exposure period: 24 h 8 (occlusive)
- Site: flank
- Concentrations: 100 % an 30 % v/v in paraffin oil
- Evaluation (hr after challenge): 24 and 48 h
Positive control substance(s):
not specified
Positive control results:
It is not reported whether there are regular experiments with a positive control substance conducted in the testing facility to test the guinea pig strain for positive response and the study personal to be able to identify a positive response. Due to animal welfare there is usually no positive control for each experiment.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
19
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 19.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 10.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30%
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30%. No with. + reactions: 10.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30%
No. with + reactions:
7
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30%. No with. + reactions: 7.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
30%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
sensitising
Remarks:
Migrated information
Executive summary:

A Maggnusson & Kligman Maximization test was conducted accoording to GLP-requirements and OECD Guideline No. 406. 10 of 20 Dunking Hartley guinea pigs developed a contact dermatitis against 30 % RAPI-cure CHVE in paraffin oil in that test.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A Maggnusson & Kligman Maximization test was conducted accoording to GLP-requirements and OECD Guideline No. 406. 10 of 20 Dunking Hartley guinea pigs developed a contact dermatitis against 30 % 1,4-bis[(vinyloxy)methyl]cyclohexane in paraffin oil.


Migrated from Short description of key information:
Maggnusson & Kligman Maximization test (OECD Guideline No. 406): sensitising

Justification for selection of skin sensitisation endpoint:
Only one study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
No case reports known.

Justification for classification or non-classification

Classification for sensitisation (cat. 1) is warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.