Registration Dossier
Registration Dossier
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Reaction mass of isomers disodium 8-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-5-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, disodium 5-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-8-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
EC number: 700-946-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations of 3%, 6% and 12.5% (w/v), each diluted with 2% carboxymethylcellulose (CMC) in physiological saline 0.9% NaCl(v/v). The concentration of 12.5% in 2% CMC inphysiological saline 0.9% NaCl(v/v) was the maximum technically applicable concentration of the test item in the vehicle.
As the stimulation index for the test concentration of 12.5% was 3, the EC3 value is 12.5. The measurement of the ear thickness did not reveal any relevant increase of the ear thickness in any dosage group.
The results of radioactivity determination were supported by the means of the ear thickness per group, which showed no relevant difference compared to the negative control.
Consequently, under the conditions of this study and according to OECD 429 the test item was found to be skin sensitizer.
Justification for classification or non-classification
Based on the available data a classification as Skin Sens.1 (H317) as per the CLP Regulation (EC) No. 1272/2008 is proposed for the substance.
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