Registration Dossier
Registration Dossier
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EC number: 402-240-5 | CAS number: 102561-46-6 BONTRON P-51
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
- Study period:
- Details not available
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- not specified
- Justification for non-LLNA method:
- The data available for registration was preprared prior to the requirement for the LLNA data. The data are, though, adequate for classification and additional animal data are not justified under te principles of reducing repeat animal testing
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Details not available
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- Concentration of test material and vehicle used at induction:Intradermal injection: 7.5% w/w in liquid paraffin.Topical application: 50% w/w in liquid paraffin.Concentration of test material and vehicle used for each challenge:50% and 25% w/w in liquid paraffin.
- Route:
- other: Not specified
- Vehicle:
- no data
- Concentration / amount:
- Concentration of test material and vehicle used at induction:Intradermal injection: 7.5% w/w in liquid paraffin.Topical application: 50% w/w in liquid paraffin.Concentration of test material and vehicle used for each challenge:50% and 25% w/w in liquid paraffin.
- No. of animals per dose:
- Number of animals in test group: 20Number of animals in negative control group: 10
- Details on study design:
- Details not available
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 6.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- 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: 50%. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Not sensitising
- Executive summary:
The skin sensitisation was determined using the OECD 406 and EU B6 test methods. Details are not available, but the data has been reviewed by a suitable EU Competent Authority and provided by ECHA. The test substance is not sensitising.
Reference
Signs of irritation during induction: Not specified
Evidence of sensitisation of each challenge concentration: No evidence of delayed contact hypersensitivity seen in any of the test 20 animals.
Localised dermal reactions were observed (restricted to a small area of the challenge site).
Other observations: The dermal reaction seen in the test animals were similar to those seen in the controls.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
Skin Sensitisation: Not sensitising (Guinea Pig) [Key study & supporting study].
Justification for selection of skin sensitisation endpoint:
Data has been provided by ECHA from a previous notification. The data has been reviewed by a suitable Competent Authority and adjudged to be suitable for registration.
Justification for classification or non-classification
The substance is not classified under CLP as it does not fill the requirements for skin sensitising 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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