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Administrative data

Description of key information

No repeated dose toxicity study with zinc ditetradecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the entities formed upon dissolution of zinc ditetradecanoate, namely zinc and tetradecanoate.Since the naturally occurring fatty acid tetradecanoic acid (aka Myristic acid) is void of any human health hazard potential, the hazard assessment will be derived based on the toxicological information for zinc and the human life-time NOAEL of 0.83 mg/kg bw/day will be used further.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Zinc

From studies in which humans were supplemented with zinc (as zinc gluconate) it was concluded that women are more sensitive to the effects of high zinc intake and that a dose of 50 mg Zn/day is the human NOAEL. This corresponds to a daily exposure of 0.83 mg Zn/kg bw. At the LOAEL of 150 mg Zn/day, clinical signs and indications for disturbance of copper homeostasis have been observed. Studies conducted on animals are not discussed here, since information on human experience are considered of higher relevance for hazard assessment purposes and should take precedence over animal studies. For further information on the toxicity of zinc, please refer to the relevant sections in the IUCLID and CSR.

 

Tetradecanoic acid

According to Regulation (EC) No 1907/2006 Annex V substances obtained from natural sources and not modified such as vegetable fats and oils as well as fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts are excluded from the obligation to register.

Tetradecanoic acid is a saturated straight-chain C14-fatty acid, which is present in bovine milk, breast milk as well as palm kernel oil, coconut oil and butterfat.

 

In the UK and in several other countries, “the Department of Health have set dietary reference values for fatty acids and recommend that total fatty acid intake should average 30 % of total dietary energy including alcohol (DoH, 1991). The available data demonstrate the low toxicity of fatty acids and their salts, which is consistent with the long history of safe use in foods for both fatty acids and glycerides. Several of the fatty acids are Generally Recognised as Safe (GRAS) by the U.S. Food and Drug Administration (US FDA). Substances that are listed as GRAS include: stearic acid; oleic acid and sodium palmitate. Stearic acid is also included by the Council of Europe (1974), at a level of 4000 ppm, in the list of artificial flavouring substances that may be added to foodstuffs without hazard to public health” (HERA, 2002).

“In 1974, the WHO set an unlimited ADI for the salts of myristic (C14), palmitic (C16) and stearic (C18) acids. They stated that myristic, palmitic and stearic acid and their salts are normal products of the metabolism of fats and their metabolic fate is well established. Provided the contribution of the cations does not add excessively to the normal body load there is no need to consider the use of these substances in any different light to that of dietary fatty acids (WHO, 1974; JECFA, 1986)” (HERA, 2002).

 

Based on the results of repeated dose toxicity studies with fatty acids as described above, the conduct of any further toxicity studies with repeated exposure in animals would not contribute any new information and is therefore not considered to be required.

 

 

Zinc ditetradecanoate

Since no repeated dose toxicity study is available specifically for zinc ditetradecanoate, information on the individual constituents zinc and tetradecanoic acid will be used for the hazard assessment and when applicable for the risk characterisation of zinc ditetradecanoate.

Naturally occurring fatty acids are generally not considered to represent a hazard to humans, which is reflected in their exclusion from REACH registration requirements (cf REACH Annex V (Regulation (EC) No 987/2008)). Since the naturally occurring fatty acid tetradecanoic acid (aka Myristic acid) is void of any human health hazard potential, zinc is considered as the toxicological driver for the DNEL derivation. Hence, the DNEL for zinc ditetradecanoate will be derived based on the toxicological information for zinc. In case of zinc in zinc ditetradecanoate, the NOAEL of 0.83 mg/kg bw/day (human data) will be used.

Justification for classification or non-classification

In relevant and reliable repeated dose toxicity studies as well as human data for bothentities formed upon dissolution of zinc ditetradecanoate, namely zinc and tetradecanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. Hence, no classification for zinc ditetradecanoate as STOT-RE is required.

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