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Description of key information

There is no toxicokinetic information available on the substance. An evaluation of the absorption is based on the physichochemical properties of the substance.

Key value for chemical safety assessment

Additional information

There is no toxicokinetics, metabolism and distribution data available on Dodecane -12 -Lactam Manufacturing of, by-products from, distillation residues.

Therefore, the assessment of the toxicokinetic Dodecane-12 -Lactam Manufacturing of, by-products from, distillation residues

is based on the available toxicological data and the physicochemical properties as suggested by the REACH Guidance Chapter R.7 c. The substance is an UVCB substance mainly composed of amino 12 -dodecanoic acid, dodecance 12 lactam and polyamide 12 -oligomer with inorganic salts.

Molecular weight of the major components is as follows: dodecane 12 lactame (197.32 g/mole) , 12 aminododecanoic acid (215.33 g/mole) and polyamide 12 oligomer (591.95 g/mole).

Water solubility : 100 -1000 mg/L at 25°C (moderately soluble)

Partition coefficient log Kow> 3

ABSORPTION

Oral route

According to the REACH Guidance, the physicochemical characteristics and the molecular mass of the different major components are in a range suggestive of absorption as such from the gastro-intestinal tract subsequent to oral ingestion. This assumption of oral absorption is supported by clinical signs observed in animals given the high dose level of 2000 mg/kg/day in the acute oral toxicity study (hypoactivity, lateral/ventral recumbency and sedation were observed in almost all animals, accompanied in some females by hunched posture, staggering gait, half-closed eyes, ptyalism, tremors and/or dyspnea, (Haag, 2011) as well as the changes observed in the liver and kidneys in the repeated dose toxicity study (Spézia, 2012).

Inhalation route

The substance is a solid block, nevertheless powder can be generated during some tasks.

Taking into account the physicochemical charasteristic (Water solubility and Log P) and the molecular mass of the difference major components, favourable absorption directly across the respiratory tract epithelium by passive diffusion is assumed according to the Reach guidance 7c. As no acute or repeated inhalation toxicity study is available, a default value of 100% of absorption is proposed for the risk assessment.

Dermal absorption

According to the REACH Guidance, the n-Octanol/water partition coefficient is > 3, the water solubility and molecular weight of the substances are in ranges which favour dermal absorption. In such circumstances, a default value of 100% skin absorption will be used.

ELIMINATION AND EXCRETION

There is no data on elimination and excretion.

The following information is taken into account for any hazard / risk assessment:

No data on toxicokinetics, metabolism and distribution are available . Based on the physicochemical carasteristic of the substance and the complex composition of the UVCB substance, Dodecance-12 -lactam Manufacturing of, by-products from, distillation residues is expected to be well absorbed by the respiratory and gastro-intestinal tracts and through the skin.

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