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Toxicological information

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Description of key information

No skin sensitisation study with zinc ditetradecanoate is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties zinc and tetradecanoate. Zinc ditetradecanoate is not expected to show signs of dermal sensitisation, since the two moieties zinc and tetradecanoate have not shown any skin sensitisation potential in experimental studies.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

zinc ditetradecanoate

Zinc ditetradecanoate is not expected to show signs of dermal sensitisation, since the two moieties zinc and tetradecanoate have not shown any skin sensitisation potential in experimental studies. Thus, zinc didocosanoate is not to be classified according to regulation (EC) 1272/2008 as skin sensitising. Further testing is not required. For further information on the toxicity of the individual assessment entities, please refer to the relevant sections in the IUCLID and CSR.

 

zinc

The skin sensitising potential of zinc oxide (purity 99.69%) was investigated in female Dunkin Hartley guinea pigs in two well-performed maximisation tests, conducted according to Directive 96/54/EC B.6 and OECD guideline 406. Based on the results of a preliminary study, in the main studies experimental animals (10 in each test) were intradermally injected with a 20% concentration and epidermally exposed to a 50% concentration (i. e. the highest practically feasible concentration). Control animals (5 in each test) were similarly treated, but with vehicle (water) alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50% test substance concentration and the vehicle. In the first study, in response to the 50% test substance concentration skin reactions of grade 1 were observed in 4/10 experimental animals 24 hours after the challenge (40% sensitisation rate), while no skin reactions were evident in the controls. In contrast, in the second study no skin reactions were evident in the experimental animals (0% sensitisation rate), while a skin reaction grade 1 was seen in one control animal. The skin reaction observed in one control animal is probably a sign of non specific irritation (Van Huygevoort, 1999b1, 1999b2).

In a third well-performed maximisation test, conducted according to the same guidelines and with the same experimental design, another analytical grade zinc oxide was tested (Zincweiß Pharma A; purity 99.9%). The only difference with the studies described above was the intradermal induction concentration, which was 2% as for Zincweiß Pharma A this was considered the highest concentration that could reproducibly be injected. In this test no skin reactions were evident in both experimental and control animals, hence a 0% sensitisation rate for Zincweiß Pharma A. White staining of the treated skin by the test substance was observed in some animals 24 and 48 hours after challenge (Van Huygevoort, 1999a).

Human data:

In a human patch test performed with 100 selected leg-ulcer patients, 11/100 patients gave an allergic reaction with zinc ointment (60% ZnO and 40% sesame oil). However, 14/81 patients gave a positive response when treated with sesame oil alone. This study does not give any indication for a skin sensitizing potential of zinc oxide in humans (Malten and Kuiper, 1974).

The effect of zinc oxide on contact allergy to colophony was investigated. With 14 patients with earlier history of moderate patch test reactions to colophony (a patch test) with 10% ZnO (2.3 mg Zinc/cm²) with and without colophony was performed. No positive response was observed in the 14 patients when only a 10% solution of zinc oxide was used. The addition of zinc oxide to colophony decreased the allergic reaction induced by colophony (Söderberg et al., 1990). All available data suggests this compound does not have skin sensitisation potential.

 

tetradecanoate

According to the Review of Cosmetic Ingredients (2010) cosmetic product formulations containing different concentrations of fatty acids like tetradecanoic acid were not primary or cumulative irritants, nor sensitisers. The substance subjected to registration – Zinc ditetradecanoate- has 122 reported uses with concentrations up to 20 % in cosmetic products. On the basis of available data from studies using animals and humans, it was concluded by the Cosmetic Ingredients Review that tetradecanoic acid is safe in current practices and their use and concentration in cosmetics (CIR, 2010).

Supporting data also demonstrate that fatty acids with similar chain lengths such as decanoic acid (C10) and stearic acid (C18) have no sensitising potential.

The non-sensitising properties of fatty acids where demonstrated in a skin sensitisation study in 28 volunteers: “Five 48-hour covered applications of 1% decanoic acid (C10) in petrolatum were made over a 10 day period. The results were negative since none gave positive reactions when challenged 10-14 days after the induction phase with a final 48-hour closed patch test using 1% in petrolatum (IUCLID, 2000a)” (HERA, 2002).

Further on, “no local reactions indicative of sensitisation were seen in 100 subjects patch tested [under unspecified conditions] with a bath soap and detergent formulation containing 0.3-0.75% sodium stearate (BIBRA, 1990). De Groot et al. (1988) reported that 25 subjects showed no sensitisation reactions when exposed to 5% stearic acid (C18) in petrolatum and a 1% aqueous sodium stearate solution” (HERA, 2002).

Sensitisation by or intolerance to an abundantly available essential substance such as tetradecanoic acid would be grossly implausible and can therefore safely be excluded.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As the two moieties of zinc ditetradecanoate are not sensitising, zinc ditetradecanoate in all probability has also no sensitising activity.

According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, zinc ditetradecanoate does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact.