Registration Dossier
Registration Dossier
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Reaction mass of:pentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(6-amino-1-hydroxy-3-sulfonatonaphthalen-2-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-8-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate andpentasodium 7-amino-3-((E)-(4-((Z)-(4-(4-((E)-(4-((E)-(2-amino-5-hydroxy-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonato-5,8-dihydronaphthalen-1-yl)diazenyl)-2-sulfonatophenylamino)phenyl)diazenyl)-6-sulfonatonaphthalen-1-yl)diazenyl)-4-hydroxynaphthalene-2-sulfonate
EC number: 940-364-6 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
- 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:
- study available
- Species:
- other: albino guinea pig
- Concentration / amount:
- Concentration of the test material used at induction:
a) intracutaneous: 1 g/100 ml water p.l.
b) epicutaneous: 1g/100 ml water p.l.
Concentration of test material and vehicle used for challenge:
epicutaneous: 1 g/100 ml water p.l. - Concentration / amount:
- Concentration of the test material used at induction:
a) intracutaneous: 1 g/100 ml water p.l.
b) epicutaneous: 1g/100 ml water p.l.
Concentration of test material and vehicle used for challenge:
epicutaneous: 1 g/100 ml water p.l. - No. of animals per dose:
- Number of animals in test group: 40
Number of animals in negative control group: 40 - Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 7
- Total no. in group:
- 40
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 7.0. Total no. in groups: 40.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 40
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 40.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 40
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 40.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 40
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 40.0.
- Interpretation of results:
- other: not classified under Regulation 1272/2008
- Remarks:
- Migrated information
Reference
Maximu concentration not causing irritating effects in preliminart test: 1%
Sign of irritation during induction: no skin reactions on the guinea pig skin were observed
Evidence of sensitisation of each challenge concentration: 7 of 20 animals in the test gropup and 2 of 20 animals in the negative control group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The analogue substace was tested for sensitising properties following EU Methob B6. Under the experimental conditions (in vivo traditional sensitisation test with Guinea Pig) the substance did not elicit any sensitisation.
Based on the read across considerations the same applies to Direct Blue 299
Migrated from Short description of key information:
no sensitising
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is not classified for skin sensitisation under Regulation 1272/2008.
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.
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