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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 200-186-5 | CAS number: 53-86-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable publication which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- The optimization test
- Author:
- Maurer, T
- Year:
- 1 985
- Bibliographic source:
- Current Problems in Dermatology, 1985, 14: 114 - 151
Materials and methods
- GLP compliance:
- not specified
- Type of study:
- Maurer optimisation test
Test material
- Reference substance name:
- Indometacin
- EC Number:
- 200-186-5
- EC Name:
- Indometacin
- Cas Number:
- 53-86-1
- Molecular formula:
- C19H16ClNO4
- IUPAC Name:
- 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: (Pirbright white (DHP))
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: (physiological saline and petrolatum)
- Concentration / amount:
- intradermal administration: 0.1 %
epidermal challenge: 10% in petrolatum
Challengeopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: (physiological saline and petrolatum)
- Concentration / amount:
- intradermal administration: 0.1 %
epidermal challenge: 10% in petrolatum
- No. of animals per dose:
- 20
Results and discussion
Any other information on results incl. tables
Response on day 35 after intradermal challenge: 8 of 20 animals showed a positive reaction
Response on day 45 after epidermal challenge: 0 of 20 animals showed a positive reaction
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- mildly sensitising agent
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.
