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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 401-310-2 | CAS number: 93912-64-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Maximised method, Magnusson and Kligman
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time of testing the LLNA method did not exhist
Test material
- Reference substance name:
- -
- EC Number:
- 401-310-2
- EC Name:
- -
- Cas Number:
- 93912-64-2
- Molecular formula:
- Hill formula: C37H23N10O22S7Cl.6Na CAS formula: C37H23N10O22S7ClNa6
- IUPAC Name:
- Hexasodium 2-[8-amino-7-[[5-[[4-chloro-6-[[3-[[2-(sulfato)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl] amino]-2 sulfonatophenyl]azo]-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]-naphthalene-1,5-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Material applied as 10% in water intradermally. Freunds complete adjuvant also applied intradermally.
Topical induction was with a 50% mixture in water following treatment with sodium lauryl sulphate.
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Material applied as 10% in water intradermally. Freunds complete adjuvant also applied intradermally.
Topical induction was with a 50% mixture in water following treatment with sodium lauryl sulphate.
- Challenge controls:
- Concentrations of test material and vehicle used at each stage of challenge: 50% mixture in petrolatum.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
|
|
Number of animals showing skin reactions after |
|||
|
Challenge concentrations of test substance |
1st challenge 24hr 48hr |
2nd challenge 24hr 48hr |
||
Test group |
50 |
0 |
0 |
|
|
Negative control group |
50 |
0 |
0 |
|
|
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.
