Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 435-070-5 | CAS number: -
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:
- other: Data originally submitted as part of the 67/548/EEC notification package.
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.6 (Meerschweinchen-Maximierungstest (GPMT))
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: GOHI (SPF)
- Sex:
- not specified
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) Intradermal induction: 5 % in corn oil b) Epidermal induction: 75 % in corn oil Concentration of test material and vehicle used for each challenge: 75 % in corn oil
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- corn oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) Intradermal induction: 5 % in corn oil b) Epidermal induction: 75 % in corn oil Concentration of test material and vehicle used for each challenge: 75 % in corn oil
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal induction: Erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. Epidermal induction: Discrete/patchy erythema was observed in all animals at the 24- and 48- hour reading after treatment with the test item.
Other observations: One animals of the test group was found dead on test day 10. At necropsy, no macroscopic findings were noted. The death was considered to be spontaneous and treatment unrelated. - Executive summary:
Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal induction: Erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. Epidermal induction: Discrete/patchy erythema was observed in all animals at the 24- and 48- hour reading after treatment with the test item.
Other observations: One animals of the test group was found dead on test day 10. At necropsy, no macroscopic findings were noted. The death was considered to be spontaneous and treatment unrelated.
The substance is not classified.
Reference
Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal induction: Erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. Epidermal induction: Discrete/patchy erythema was observed in all animals at the 24- and 48- hour reading after treatment with the test item.
Other observations: One animals of the test group was found dead on test day 10. At necropsy, no macroscopic findings were noted. The death was considered to be spontaneous and treatment unrelated.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Maximum concentration not causing irritating effects in preliminary test: 75 % Signs of irritation during induction: Intradermal induction: Erythema, oedema, necrotizing dermatitis, encrustation and exfoliation of encrustation. Epidermal induction: Discrete/patchy erythema was observed in all animals at the 24- and 48- hour reading after treatment with the test item.
Other observations: One animals of the test group was found dead on test day 10. At necropsy, no macroscopic findings were noted. The death was considered to be spontaneous and treatment unrelated.
The substance is not classified.
Migrated from Short description of key information:
No sensitising effects noted.
Justification for selection of skin sensitisation endpoint:
GLP study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
