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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 931-195-9 | CAS number: -
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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 84/449/EEC B5 (maximixation test) OECD 406 1981
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed before the REACH regulation.
Test material
- Reference substance name:
- A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
- EC Number:
- 403-490-8
- EC Name:
- A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
- IUPAC Name:
- 403-490-8
- Reference substance name:
- reaction mass of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate, diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate, propylene carbonate
- IUPAC Name:
- reaction mass of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate, diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate, propylene carbonate
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- induction:
intradermal 0.1 ml of 1% w/w in propylene glycol
epidermal: 0.5 ml of 25% w/w in propylene glycol
challenge: 0.5 ml of 25% w/w in propylene glycol
Challengeopen allclose all
- Route:
- other: epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- induction:
intradermal 0.1 ml of 1% w/w in propylene glycol
epidermal: 0.5 ml of 25% w/w in propylene glycol
challenge: 0.5 ml of 25% w/w in propylene glycol
- No. of animals per dose:
- 20 animals in test group
- Challenge controls:
- 10 animals in negative control group
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 2
- Clinical observations:
- no data
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- no data
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
Any other information on results incl. tables
Maximum concentration not causing irritation in preliminary tests: 25%.
Signs of irritation during induction: 0/10
Evidence of sensitisation of each challenge concentration: 3/20
Other observations:
No skin reaction observed in any of the control aninals
1 animal showed scaliness in the substance treated group
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Not skin sensitizer
- Conclusions:
- The substance is not skin sensitising
- Executive summary:
Due to the lack of information provided by ECHA, it is difficult to assess this end point fully.
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.
