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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of tetrasodium (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonate and (E)-7-((4-(4-chloro-6-(3-(2-(sulfooxy)ethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenyl)diazenyl)naphthalene-1,3,6-trisulfonic acid
EC number: 945-219-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- an in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test was conducted by means of Read Across approach. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Induced hypersensitive response of experimental animals to allergen challenge. Skin sensitization is immune skin reactions in guinea pigs is reflected blood flow, swelling.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A LLNA study has not been conducted because adequate data from guinea pig Maximisation test study are already available.
Test material
- Reference substance name:
- Similar Substance 01 - RY145:1
- IUPAC Name:
- Similar Substance 01 - RY145:1
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Sex:
- female
- Details on test animals and environmental conditions:
- - Numbero of animals: 20
- Non pregnant
- Weight: 250-350 g
- Diet: KO 16 ad libitum
- Water: drinking water with ascorbic acid
- Cage: T5 (supplied by Velaz)
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal:
0,1 mL at 25 %;
0,1 mL at 5 % of dye
0,1 mL at 5% of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
Challenge
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- Intradermal:
0.1 mL at 25 %
0.1 mL at 5 % of dye
0.1 mL at 5 % of dye and adjuvant (1:1)
Epicutaneous: 25 % of dye in vaseline
- No. of animals per dose:
- 2
- Details on study design:
- - Route of application: injection and patch application
- Exposure period: 72 hours
- Post-exposure period of observation: 14 days - Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 1
- Group:
- test chemical
- Dose level:
- 0,1
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- weak swelling; edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 1.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,1
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- weak swelling; edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0,1
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- weak swelling; edema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,1. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: weak swelling; edema.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non sensitising
- Executive summary:
Method
To assess the allergenic potential the test substance has been tested in albino guinea pigs, according to the OECD guideline 406.
Results
Positive reaction was found on 3 animals of the total 20 (15 % corresponding to an intradermal induction dose of 5 %).
Conclusion
Non sensitising.
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.
