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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 420-960-8 | CAS number: 77214-82-5 JOF 2822 5F; JOF 2822 5FL; JOF 4443
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)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Iron (III) tris(4-methylbenzenesulfonate)
- EC Number:
- 420-960-8
- EC Name:
- Iron (III) tris(4-methylbenzenesulfonate)
- Cas Number:
- 77214-82-5
- Molecular formula:
- C21 H21 Fe O9 S3
- IUPAC Name:
- iron(3+) tris(4-methylbenzene-1-sulfonate)
- Test material form:
- solid: pellets
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction:
Intradermal: 2.5 % w/w in physiol. saline (0.1 mL)
Topic: 25 % w/w in physiol. saline (0.5 mL)
Challenge:
Topic: 12 % w/w in physiol. saline (0.5 mL)
Challengeopen allclose all
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Induction:
Intradermal: 2.5 % w/w in physiol. saline (0.1 mL)
Topic: 25 % w/w in physiol. saline (0.5 mL)
Challenge:
Topic: 12 % w/w in physiol. saline (0.5 mL)
- No. of animals per dose:
- test group: 10
negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 12 %
- 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: 12 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 12 %
- 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: 12 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Signs of irritation during induction: none
Evidence of sensitisation of each challenge concentration: none
Other observations: none
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
