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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

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 (OECD 422) and in compliance with GLP, the reported NOAEL for the test substance, reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane, for reproductive toxicity was ≥ 1000 mg/kg bw/day, which was the highest dose tested. No adverse effects were observed in any of the animals (Charles River, 2017).

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
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 (OECD 422) and in compliance with GLP, Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silanew as 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.

No reproduction toxicity was observed up to the highest dose level tested (1000 mg/kg).

Based on these results, a reproduction No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg was derived.

Effects on developmental toxicity

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 (OECD 422) and in compliance with GLP, the reported NOAEL for the test substance, reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane, for developmental toxicity was ≥1000 mg/kg bw/day, which was the highest dose tested. No adverse effects were observed in any of the animals (Charles River, 2017).

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
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 (OECD 422) 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.

No developmental toxicity was observed up to the highest dose level tested (1000 mg/kg).

Based on these results, a developmental No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg 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 reproductive and developmental toxicity according to Regulation (EC) No 1272/2008.

Additional information