Registration Dossier
Registration Dossier
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EC number: 473-130-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
A reproductive / developmental screening study on a structural analogue is available for the substance, and this is offered in section 7.8.1. No effects were seen on reproductive organs in the repeat dose study on the substance, and the category of substance (reactive dye) is not known for reproductive toxicity effects. Also, the substance has been notified originally under the 7th Amendment, and has been in use for a number of years without effects associated with reproductive toxicity being noted. On the basis of animal welfare it is proposed that the screening study in conjunction with the lack of effects noted in the other toxicity studies is suitable to address this endpoint. An assessment of reproductive effects can be carried out at the next tonnage threshold.
Short description of key information:
A discussion of the justification for read across
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
A reproductive / developmental screening study on a structural analogue is available for the substance, and this is offered in section 7.8.1. No effects were seen on reproductive organs in the repeat dose study on the substance, and the category of substance (reactive dye) is not known for developmental toxicity effects. Also, the substance has been notified originally under the 7th Amendment, and has been in use for a number of years without effects associated with developmental toxicity being noted. On the basis of animal welfare it is proposed that the screening study in conjunction with the lack of effects noted in the other toxicity studies is suitable to address this endpoint. An assessment of developmental effects can be carried out at the next tonnage threshold.
Justification for classification or non-classification
The above read across study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for reproductive effects is therefore required.
Additional information
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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