Registration Dossier
Registration Dossier
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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.
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Reaction mass of trisodium bis[5-amino-2-(hydroxy-κO)-3-{[1-(hydroxy-κO)-2-naphthyl]diazenyl-κN1}benzenesulfonato(3-)]chromate(3-), trisodium bis[2-(hydroxy-κO)-3-{[1-(hydroxy-κO)-2-naphthyl]diazenyl-κN1}-5-nitrobenzenesulfonato(3-)]chromate(3-) and heptasodium bis[4-(hydroxy-κO)-3-{[2-(hydroxy-κO)-5-nitro-3-sulfophenyl]diazenyl-κN2}-6-(4-sulfoanilino)naphthalene-2-sulfonato(5-)]chromate(7-)
EC number: 944-619-2 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other: data obtained after Article 25(3) request
- Title:
- Unnamed
- Year:
- 2 017
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
- 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:
- Acid Black 173 - Similar Substance 01
- IUPAC Name:
- Acid Black 173 - Similar Substance 01
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Bor:DHPW (SPF)
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal: 5 %
Epicutaneous: 50 %
Challenge
- Route:
- other: not specified
- Vehicle:
- water
- Concentration / amount:
- 25 %
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20
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:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
The test sample has a slight primary irritant effect in the 50 % aqueous formulation.
Evidence of sensitisation of each challenge concentration: None
Other observations: None
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not skin sensitising
- Executive summary:
Method
The substance has been tested for its skin irritation potential according to the EU method B6.
Results
Non skin sensitising
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