Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Read across from a Rel 2 study conducted in accordance with OECD 422.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

There are no reproductive toxicity studies available for Isostearyl alcohol.

The constituents of ISOSTEARYL ALCOHOL (REPLACE WITH UVCB REGISTRATION NAME WHEN AGREED) share a common chemistry, incorporating an alcohol functional group on an alkyl chain, with C-numbers in the range (C14-C20, predominantly C16-C18). The alkyl structures are predominantly monobranched (methyl or ethyl branching, at or beyond the 6-position) and may be considered ‘essentially linear’.

Instead read across from a reproductive toxicity screening study with Octadecanol has been used. This study which was conducted in accordance with OECD 422, GLP (rel 2) gave Oral NOAELs of greater than 2000 mg/kg bw/day (the highest dose tested) for both parental and F1 rats. (Hansen 1992b)

Short description of key information:
No studies on toxicity to reproduction/fertility were available on Isostearyl alcohol by any route. Oral NOAELs of greater than 2000 mg/kg bw/day (the highest dose tested) were determined for parental and F1 rats in reproductive toxicity screening tests with Octadecanol (Hansen 1992b)

Justification for selection of Effect on fertility via oral route:
In a reliable study conducted according to draft OECD guideline 422, parental NOAEL was 2000 mg/kg bw/day and the NOAEL for reproductive and developmental effects can be considered as greater than 2000 mg/kg bw/day (highest dose level).

Effects on developmental toxicity

Description of key information
Read across from Octadecanol (OECD 422) reported a NOAEL of greater than 2000 mg/kg (bw) for both maternal and foetal toxicity. There was no evidence of teratogenicity from the limited examination of the pups during the study. (Hansen 1992b)
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
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

There are no developmental toxicity studies available for Isostearyl alcohol.

The constituents ofISOSTEARYL ALCOHOL (REPLACE WITH UVCB REGISTRATION NAME WHEN AGREED)share a common chemistry, incorporating an alcohol functional group on an alkyl chain, with C-numbers in the range (C14-C20, predominantly C16-C18). The alkyl structures are predominantly monobranched (methyl or ethyl branching, at or beyond the 6-position) and may be considered ‘essentially linear’.

In read across from Octadecanol,development was assessed as part of a combined repeat dose and reproductive/developmental toxicity study, conducted according to draft OECD guideline 422 (Rel:2). The NOAEL for maternal and foetotoxicity in rats was 2000 mg/kg bw/day (highest dose level). There was no evidence of teratogenicity from the limited examination of the pups that was carried out.(Hansen 1992b)

Justification for classification or non-classification

Based on the available data, Isostearyl alcohol would not be classified as toxic to reproduction under Regulation (EC) No. 1272/2008 (CLP) or Directive 67/548/EEC (DSD).

Additional information