Registration Dossier
Registration Dossier
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EC number: 400-830-7 | CAS number: 104810-48-2 EVERSORB 80; TINUVIN 1130; TINUVIN 213
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- other: information from migrated NONS file as per inquiry # [06-0000014115-81-00000], permission to refer granted by ECHA
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V (Maximisation test)
- GLP compliance:
- yes
- Type of study:
- other: information from migrated NONS file as per inquiry # [06-0000014115-81-00000], permission to refer granted by ECHA
- Species:
- guinea pig
- Concentration / amount:
- Concentration of test material and vehile used for each challenge:
1% (epidermal) in vaseline - Concentration / amount:
- Concentration of test material and vehile used for each challenge:
1% (epidermal) in vaseline - No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20 - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- not available
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Clinical observations:
- not available
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: not available. No with. + reactions: 14.0. Total no. in groups: 20.0. Clinical observations: not available.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- not available
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Clinical observations:
- not available
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: not available. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: not available.
- Interpretation of results:
- other: irritant
Reference
Signs of irritation during induction:
TEST GROUP: At challenge 14/20 after 24 hours, 10/20 after 48 hours.
CONTROL GROUP: At challenge 0/20
Evidence of sensitation of each challenge concentration: 14/20
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information in the dossier, the substance 400-830-7 need to be classified as Sensitisation (Xi, R43) when considering the criteria outlined in Annex VI of 67/548/EEC and classified as Skin Sens. 1 when considering the criteria outlined in Annex I of 1272/2008/EC and its adaption (EU) No 286/2011.
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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