Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 442-070-9 | CAS number: 329039-38-5
Endpoint summary
Administrative data
Description of key information
oral rat 70 days: NOAEL 75 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 75 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test accoirding to OECD guideline 422 (Tyl, 2002) male and female rats were treated with 25, 75 and 225 mg/kg bw/day Methyldiacetoxyisopropoxysilane. Female rats were treated daily for 10 weeks, male rats daily for 6 weeks. Furthermore the F1 generation was treated from weaning (pnd 21), for approximately seven more weeks (dosing for F1 selected pups began on pnd 22 and continued until all pups were at least 70 days of age). Only mild systemic toxicity in F0 parental males at 225 mg/kg/day was observed, expressed as sporadic effects on hematologic and neurobehavioral parameters and histopathologic lesions in the stomachs of F0 (but not Fl) males. There were no treatment- or dose-related effects on absolute organ weights or organ weights relative to terminal body or brain weights, or on gross findings, clinical chemistry, or urinalysis. In conclusion, administration of In conclusion, administration of Methyldiacetoxyisopropoxysilane by gavage once daily at 0, 25, 75, or 225 mg/kg bw/day to parental F0 rats, ten/sex/group, through prebreed, mating, gestation, and lactation, and direct dosing to F1 offspring from weaning to scheduled sacrifice on or about pnd 70, resulted in minimal adult F0 parental toxicity at 225 mg/kg/day. Therefore, under the conditions of this study, the no observable adverse effect level (NOAEL) for systemic parental toxicity is 75 mg/kg bw/day.
Justification for classification or non-classification
Regarding the values from an oral repeated dose toxicity study in rats of a NOAEL of 75 mg/kg bw/day and a LOAEL of 225 mg/kg bw/day, methyldiacetoxyisopropoxy silane is classified:
DSD: Not Classified
CLP: Not Classified
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.
