Registration Dossier
Registration Dossier
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: 279-408-8 | CAS number: 80157-00-2
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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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:
- Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate
- EC Number:
- 279-408-8
- EC Name:
- Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate
- Cas Number:
- 80157-00-2
- Molecular formula:
- C28H20ClN9Na4O16S5
- IUPAC Name:
- tetrasodium 7-[(1E)-2-[2-(carbamoylamino)-4-{[4-chloro-6-({3-[2-(sulfonatooxy)ethanesulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}phenyl]diazen-1-yl]naphthalene-1,3,6-trisulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: 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.
- Group:
- negative control
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- other: not reported
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.
