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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 239-346-4 | CAS number: 15307-79-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- january 1976 - february 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- other: Identification of Contact Allergens by Guinea Pig Maximization test ( Magnusson / Kligman)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
- EC Number:
- 239-346-4
- EC Name:
- Sodium [2-[(2,6-dichlorophenyl)amino]phenyl]acetate
- Cas Number:
- 15307-79-6
- Molecular formula:
- C14H11Cl2NO2.Na
- IUPAC Name:
- sodium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- induction: 0.1 ml of complete Freund`s adjuvant, diluted 1:1 with distilled water (intracutaneous)
induction: 0.1 ml of a 5% solution of Diclofenac Sodium Salt (intracutaneous)
induction: 0.5 ml of a 10% solution Diclofenac Sodium Salt (applied to the dorsal skin)
challenge: 0,1 ml of a 10% solution Diclofenac Sodium Salt (applied to the flank skin)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- induction: 0.1 ml of complete Freund`s adjuvant, diluted 1:1 with distilled water (intracutaneous)
induction: 0.1 ml of a 5% solution of Diclofenac Sodium Salt (intracutaneous)
induction: 0.5 ml of a 10% solution Diclofenac Sodium Salt (applied to the dorsal skin)
challenge: 0,1 ml of a 10% solution Diclofenac Sodium Salt (applied to the flank skin)
- No. of animals per dose:
- 20 animals for the test preparation and 20 animals for the control
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- not detected
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: not detected.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According the classification criteria described in REGULATION (EC) No 1272/2008 (CLP), the product has not to be classified as a sensitizer.
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.
