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Administrative data

Description of key information

In a reliable 90-day study, using a protocol similar to OECD guideline 408, an oral NOAEL of 169 mg/kg bw/day was determined for Alcohols C14-15 branched and linear in rats (Ito et al. 1978) but the effects seen in this study are not ascribed to a dose response effect, and therefore are not suitable as a basis for DNEL. Studies with Hexadecanol and Alcohols C16-18 and C18 unsatd. gave NOAELs of >4257  (Scientific Associates 1996a). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966).

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
723 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

In some cases the CAS and chemical identity stated refer to SDA nomenclature for this substance. In REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR

 

The key study was performed using a protocol similar to OECD guideline 408 but prior to the introduction of GLP. The test material (Dobanol 45) was administered to rats via the diet for 90 days and an NOAEL of 169 mg/kg bw/day was identified based on effects on body weight, food consumption, food efficiency and clinical chemistry at 748 mg/kg bw/day and above (Ito et al. 1978). The effects seen in this study are not ascribed to a dose response effect, and therefore are not suitable as a basis for DNEL.

The Category hypothesis is that the long chain linear aliphatic alcohol family has at its centre an homologous series of increasing carbon chain length, which is associated with a consistency and predictability in the property data across the group, for the physicochemical, environmental and toxicological property data sets. In view of the structural and chemical similarities, it is considered that the results from two reliable repeated dose toxicity studies on single- or multiple-constituent alcohols with appropriate chain lengths can be read across to Alcohols C14-15 branched.

For Hexadecanol, oral NOAELs were >4257 and >4567 mg/kg bw/day in male and female rats respectively in a 90-day repeated dose toxicity test in which a somewhat limited range of endpoints was evaluated. The NOAELs were based on adverse effects in males and females at 1822 and 2064 mg/kg bw/day and above, respectively, including reduced food consumption in both sexes and also reduced body weight gain and some organ weight changes in females (Scientific Associates 1966a). For Hexanol, oral NOAELs were 1127 and 1243 mg/kg bw/day (the highest doses tested) in male and female rats respectively in a 90-day repeated dose toxicity test in which a somewhat limited range of endpoints was evaluated (Scientific Associates 1966a).

 

 

No repeated dose toxicity studies were available on any of the long chain linear aliphatic alcohol family by the dermal route.

 

No reliable repeated dose toxicity studies were available on any of the relevant members of the long chain linear aliphatic alcohol family by the inhalation route.

Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested. Rather than having separate values for the three endpoints, one endpoint systemic effects has been used instead. Since the NOAELs do not vary greatly across the category, one key study has been chosen as being representative of the whole category.

 

C6, Hexanol has been chosen as the category representative because shorter chain molecules are usually regarded as more toxic when compared to structural analogues with longer carbon chain lengths.

Justification for classification or non-classification

Based on the available data, Alcohols C14-15-branched would not be classified for specific target organ toxicity-repeated exposure under Regulation (EC) No. 1272/2008 (CLP) since no adverse effects occurred at <100 mg/kg bw/day, or for danger of serious damage to health by prolonged exposure under Directive 67/548/EEC (DSD) since no adverse effects occurred at <50 mg/kg bw/day. Tests on similar substances included in this category are also supportive of these results, which do not warrant classification under DSD or GHS criteria.