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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EC number: 402-860-6 | CAS number: 110553-27-0 CG 25-1320; IRGANOX 1520; TK 12229/1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No additional data
Additional information
The majority of the substance data set is taken from existing registrations on the substance, where the data is > 12 years old. As such, no definitive data on the reproductive toxicity of the substance is available. There is data on developmental toxicity, where apart from maternal toxicity noted in the study, there were no perceived developmental effects. Given the low toxicity of the substance, and lack of effects noted within the developmental study, mutagenicity and repeat dose studies, it is unlikely that the substance will pose a hazard for this endpoint. Therefore, in the interests of animal welfare, it is considered justifiable to postpone assessment for this endpoint until the next tonnage level of registration.
Short description of key information:
Discussion on proposal to waive assessment of the fertility toxicity endpoint until the next level of registration.
Effects on developmental toxicity
Description of key information
Summary of developmental toxicity / teratogenicity study
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 150 mg/kg bw/day
Additional information
The dose level of 300 mg/kg elicited slight maternal toxicity (slightly reduced body weight gain and, possibly, slightly reduced food consumption. Effects on fetus - Gross: An external malformation as micrognathia was found in one foetus of group 2 (50 mg/Kg). A further foetus in a second litter of the same dose group showed bilateral anophtalmia. In group 3 (150 mg/Kg) one foetus with apodia was observed.
Justification for classification or non-classification
The above study has been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were all conducted to GLP in compliance with recognised guidelines. The majority of the information has been provided from a migrated nons file referring to studies which are more than 12 years old, with the permission of ECHA.
The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
