Registration Dossier
Registration Dossier
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EC number: 208-768-0 | CAS number: 541-15-1
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:
- Buehler test
- Justification for non-LLNA method:
- Test was performed in 2000 as common used methode - no LLNA was available at that time.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS (5)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 347 - 424 g
- Housing: singly or in pairs in solid-floor ploypropylen cages furnished with woodflakes.
- Diet: at libitum (Guinea Pig FD1 Diet, Special Diets Services Ltd. Witham, Essex, UK)
- Water: at libitum (tap water)
- Acclimation period: 5 days under test conditions prior to substance application.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air exchange: appr. 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75%
- Day(s)/duration:
- day 0 (6h) / day 7 (6h) / day 14 (6h)
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 75% / 50%
- Day(s)/duration:
- 6h
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of applications: 1
- Patch: Occlusive, epidermal administration. Filter paper with leaf aluminium (2 x 2 patch), fastened with elastic bandage
- Exposure period: 15 days
- Test groups: 1
- Control group: 1
- Site: left flank, 2 x 2 cm region shaved prior.
- Concentrations: 75 %
- Duration: 6 hours
- Frequency: 3 days, days 1, 8 and 15
- Control: distilled water
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: on day 28
- Exposure period: 6 h
- Test groups: 1
- Control group: destilled water
- Site: right flank for test substance, left flank for control. Flanks were shaved on the 29nd day
- Concentrations: 75% and 50%
- Patch: Occlusive, epidermal administration. Filter paper with leaf aluminium (2 x 2 patch), fastened with elastic bandage
- Evaluation (hr after challenge): 24 and 48 hours after removal of patch. - Challenge controls:
- distilled water
- Positive control substance(s):
- yes
- Remarks:
- DNCB and 2-Mercaptobenzothiazole
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% solution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- DNCB 0.5% w/v in Ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Induction: 2-Mercaptobenzothiazole 50% in Acetone/PEG 400 (70:30) Challenge: 50% and 25% in Acetone/PEG 400 (70:30)
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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