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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 416-140-4 | CAS number: 145650-60-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: peanut oil (induction); petrolatum (challenge)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal induction: 5% in peanut oil
b) epidermal induction: 50% in peanut oil
Concentration of test material and vehicle used for each challenge:
50% in petrolatum
Challengeopen allclose all
- Route:
- other:
- Vehicle:
- other: peanut oil (induction); petrolatum (challenge)
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal induction: 5% in peanut oil
b) epidermal induction: 50% in peanut oil
Concentration of test material and vehicle used for each challenge:
50% in petrolatum
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Positive control substance(s):
- not specified
Results and discussion
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 50 %
Signs of irritation during induction: None due to treatment with the test substance
Evidence of sensitisation of each challenge concentration: None
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU-GHS
- Conclusions:
- The test substance was found to be not sensitising to the skin of guinea pigs in a GLP study according to OECD Guideline 406.
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.
