Registration Dossier

Administrative data

Description of key information

No repeated dose toxicity studies were available on Undecanol linear and branched by any route. In a guideline reproductive toxicity screening test with Dodecanol, the oral NOAEL was 2000 mg/kg bw/day (Hansen 1992a). In guideline developmental toxicity studies, the NOAEL for maternal toxicity was 1440 mg/kg bw/day for Alcohols C7-11 branched and linear but clinical signs were seen with Octanol at 130 mg/kg bw/day (Hellwig & Jackh 1997). 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
125 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Mode of Action Analysis / Human Relevance Framework

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 multi-constituent alcohol identified as ¿Undecanol linear and branched¿ includes the following mixture:

Alcohols C6-12 type A: 5-95% linear; >= 95% C11 [range C9-C13]; even & odd (CAS 68603-15-6).

 

No repeated dose toxicity studies were available on Undecanol linear and branched by any route.

 

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 a number of reliable repeated dose toxicity studies on single- or multiple-constituent alcohols with appropriate chain lengths can be read across to Undecanol linear and branched.

An oral NOAEL of 2000 mg/kg bw/day (the highest dose tested) was established in rats for Dodecanol, in a combined repeat dose and reproductive/developmental toxicity screening test performed to draft OECD guideline 422 and to GLP (Hansen 1992a).

 

In developmental toxicity studies performed to OECD guideline 414 and to GLP, no maternal toxicity was seen in rats after oral gavage dosing with Alcohols C7-11 branched and linear at up to 1440 mg/kg bw/day on days 6 to 15 of gestation and this top dose was therefore the NOAEL. Clinical signs indicative of maternal toxicity were seen with Octanol at 130 mg/kg bw/day, the lowest dose tested (Hellwig & Jackh 1997).

 

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 guideline 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, Undecanol linear and 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.