Registration Dossier
Registration Dossier
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EC number: 413-370-7 | CAS number: 17351-75-6 RAPICURE CHVE
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Qualifier:
- according to guideline
- 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)
- 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 chemical
- 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 chemical
- 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 chemical
- 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 chemical
- 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.
Reference
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.
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