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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-282-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to an appropriate OECD test guideline (OECD422) and in compliance with GLP, the reported NOAEL for the registered substance, reaction mass of
octadecan-1-ol and
trimethyl(octadecyloxy)silane, for repeated dose toxicity was ≥1000 mg/kg bw/day, which was the highest dose tested. No adverse effects were observed in any of the test or recovery animals (Charles River, 2017).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to an appropriate OECD test guideline (OECD422) and in compliance with GLP, Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg for up to 54 days, followed by a 14-day treatment-free recovery period.
Formulation analysis showed that the formulations were prepared accurately and homogenously.
Lower body weight gain was observed in male and female rats treated at 1000 mg/kg bw/day during the treatment phase. In addition, a lower number of white blood cells were observed, in high dose males only. The magnitude of these changes was considered minimal and non-adverse, since the body weights and number of white blood cells remained within the normal range for rats of this age and strain. Moreover, the effects were not present after a 14-day recovery period.
No treatment-related changes were noted in any of the other parental parameters investigated in this study (i.e. clinical appearance, functional observations, food consumption, clinical biochemistry, organ weights and macroscopic and microscopic examination).
No reproduction toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day).
No developmental toxicity was observed up to the highest dose level tested (1000 mg/kg bw/day).
Based on these results, a parental-, reproduction- and developmental-No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg bw/day was derived.
Justification for classification or non-classification
Based on the available data for Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane, no classification is required for specific target organ toxicity following repeated exposure according to Regulation (EC) No 1272/2008.
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.
