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Diss Factsheets

Administrative data

Description of key information

No repeated dose study with substance Fatty acids, C18-24, zinc salts is available, thus the repeated dose toxicity will be addressed with existing data on the entities formed upon dissolution of substance Fatty acids, C18-24, zinc salt, namely zinc and fatty acids, C18-24. Since the naturally occurring fatty acids are 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.

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 adverse effect observed

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

FATTY ACIDS, C18-24, ZINC SALTS:

Repeated dose toxicity studies with substance Fatty acids, C18-24, zinc salts are not available. For the assessment of toxicological effects of substance Fatty acids, C18-24, zinc salts a read-across of existing toxicity data of the dissociation products zinc and fatty acids, C18-24 is applied. The hazard assessment is based on the most toxic moiety, i.e. the zinc cation.

Fatty acids are generally not considered to represent a risk to humans, which is reflected in their exclusion from REACH registration requirements (c.f. REACH Annex V (Regulation (EC) No 987/2008)).

The zinc cation is selected as most toxic moiety. However, also zinc is not expected to induce really adverse effects in humans. Zinc is essential for human growth and development, neurological functions and immunocompetence. The main clinical manifestations of zinc deficiency are growth retardation, delay in sexual maturation or increased susceptibility to infections (SCF, 2003). Health specialists recommend supplementing the diet with zinc in case human diet is zinc deficient. The maximum allowable daily intake has been established to be 50 mg zinc per day. There is no experimental sufficient evidence for specific target organ toxicity based on the reversibility of the ‘adverse’ effects demonstrated.

The chemical safety assessment in accordance with Regulation (EC) 1907/2006, Article 14 (3) came to the result that substance Fatty acids, C18-24, zinc salts does not fulfil the criteria for any of the hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB. Consequently the criteria as laid down in Article 14 (4b) are not met. Hence, actually no DNELs are required, as no risk characterisation is required. For information purposes only, an exemplary quantitative hazard assessment (DNEL derivation) has been elaborated in the document attached in section 13, namely "DNEL derivation for substance Fatty acids, C18-24, zinc salts". The DNELs have been derived on the toxicological information for zinc (NOAEL of 0.83 mg/kg bw/day, human data).

SCF 2003: Scientific Committee on Food, 2003. Opinion of the Scientific Committee on Food on the tolerable upper intake level of zinc (expressed on 5 March 2003). European Commission, Health and Consumer Protection Directorate-General, Directorate C - Scientific Opinions, C2 - Management of scientific committees; scientific co-operation and networks. [Accessed 2009 December 4]. Available from:https://ec.europa.eu/food/sites/food/files/safety/docs/sci-com_scf_out177_en.pdf

Please refer to the section for the respective assessment entity for data on the moieties. In brief:

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.

FATTY ACIDS, C18-24:

Fatty acids are generally not considered to represent a risk to humans, which is reflected in their exclusion from REACH registration requirements (c.f. REACH Annex V (Regulation (EC) No 987/2008)).

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.

Justification for classification or non-classification

As the two moieties of substance Fatty acids, C18-24, Zinc salts do not induce adverse effects leading to a STOT RE classification, substance Fatty acids, C18-24, zinc salts in all probability has also no potential for systemic toxicity leading to a classification.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptations, substance Fatty acids, C18-24, zinc salts does not have to be classified and has no obligatory labelling requirement for Specific target organ toxicity arising from repeated exposure (STOT-RE).