Registration Dossier
Registration Dossier
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Coupling reaction products of diazotized 2-amino-6-[(2-substitued ethyl)sulfonyl]naphthalene-1-substituted acid with 4-({4-chloro-6-[ethyl(3-{[2-(substituted oxy)ethyl]sulfonyl}phenyl)amino]-heteromonocycl-2-yl}amino)-5-hydroxynaphthalene-2,7-disubstituted acid and their sodium and potassium salts
EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- skin sensitisation:
One fully reliable study is available (Vogel (2010) Skin sensitisation) conducted according to OECD TG 429 and GLP (1, 2.5, and 5% (w/v) in dimethylformamide).
The SI values calculated for the substance concentrations 1.0, 2.5 and 5.0% (w/v) were 3.40, 8.79, and 11.62 respectively. The EC3 value could not be calculated, since all S.I. are above 3. Based on these results according to the recommendations made in the test guidelines, FAT 40850/A TE would be regarded as skin sensitizer. As there is a clear dose response and the S.I: is >3 at a concentration of 1.0 % (w/v) the substance is deemed a strong sensitiser (category 1A) according to CLP.
Migrated from Short description of key information:
- skin sensitisation: sensitising, category 1A, OECD TG 429; study " Vogel (2010) Skin sensitisation"
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- respiratory sensitisation: no data available
Migrated from Short description of key information:
- respiratory sensitisation: no data available
Justification for classification or non-classification
- skin sensitisation:
Based on the above stated assessment of the skin sensitisation potential of FAT 40850/A TE (S.I: is >3 at a concentration of 1.0 % (w/v)) the substance needs to be classified as R43 (May cause sensitisation by skin contact) according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and as Category 1A (H317: May cause an allergic skin reaction) according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.
- respiratory sensitisation:
As no data on respiratory sensitisation is available for FAT 40850/A TE a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL) as implementation of UN-GHS in the EU.
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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