Dodecane-1,12-diol

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Type of information:

other: toxicokinetics assessment

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The assessment of the toxicokinetics of 'Dodecane-1,12-diol' is based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.

Principles of method if other than guideline:

assessment on toxicokinetics

The remarks on the toxicokinetics are based on physico-chemical properties of the compound and on toxicological data (Tegethoff, 2020). Experimental toxicokinetic studies were not performed.

 

Additional information

The following remarks on the toxicokinetics of 'Dodecane-1,12-diol’ are based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.

The physico-chemical characteristics of the registered substance in sum do not favour oral and/or dermal absorption.

-       White solid

-       molecular mass of 202.33 g/mol

-       Low vapour pressure (4.3 x 10-5 Pa at 20°C)

-       low water solubility (18.7 mg/L at 20°C) and

-       log Pow of 3.1 (OECD TG 117)

Oral absorption:

The studies with oral exposure do not point to oral/gastrointestinal absorption.

A single oral dose of 10,000 mg/kg bw was tolerated in rats without mortalities, effects on body weight development and gross pathological findings (OECD TG 401). In a combined 28-day repeated dose toxicity study with reproduction/developmental toxicity screening on rats with oral exposure for > 28 days (OECD 422) and doses up to the limit dose of 1000 mg/kg bw/day no test item-related changes were noted in any of the parameters investigated. The No Observed Adverse Effect Levels (NOAEL) for 1,12-Dodecanediol was established to be at least 1000 mg/kg/day.

The results of the OECD 422 study did not reveal any indication of an accumulation potential of the substance.

Dermal absorption:

The studies with dermal exposure do not point to dermal absorption.

In vivo skin and eye irritation studies following OECD 404 and 405 did not reveal any signs of local toxicity. Also in vitro the registered substance showed no cytotoxic effects to skin and mucosal membrane tissues. In a skin sensitization study on mice following OECD 429 (LLNA) with doses of up to 10% in acetone/olive oil (4:1) no indication for skin irritation and/or skin sensitization became obvious.

Results of in vitro mutagenicity tests in bacteria (OECD 471) and mammalian cells (OECD 476 and 487) with and without metabolic activation showed that ‘Dodecane-1,12-diol’ is not a mutagen. Thus, it is concluded that DNA-reactive metabolites are not generated in the course of a potential hepatic biotransformation.