Registration Dossier

Administrative data

Description of key information

key studies demonstrate a lack of irritation/corrosion potential

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

FATTY ACIDS, C14 -18 AND C16 -18 -UNSATD., ZINC SALTS:

Fatty acids, C14-18 and C16-18 -unsatd., zinc salts (CAS 67701-12-6) is a zinc salt of a fatty acid containing 14-18 C-atoms. Thus, read-across of data available for zinc salts of shorter-chained (C8, C12) and similar chained (C16-18) fatty acids based on structural similarity, water solubility and zinc content in a conservative, worst-case approach is assumed to adequately describe the toxicological potential of Fatty acids, C14-18 and C16-18-unsatd., zinc salts. The irritation and corrosion potential is described with information read-across from relevant zinc soaps (zinc salts of shorter-chained (C8, C12) and similar-chained (C16-18) fatty acids) as well as supporting information from slightly soluble/insoluble zinc compounds. A 1:1 read-across of toxicological data of (i) Octanoic acid, zinc salt, basic; (ii zinc dilaurate; (iii) Fatty acids, C16-18, zinc salts; and (iv) zinc oxide is applied toFatty acids, C14-18 and C16-18-unsatd., zinc salts as it is assumed that during exposure Fatty acids, C14-18 and C16-18-unsatd., zinc salts would be changed (at least in part) to ionic zinc and its fatty acid moiety. Consequently following the worst-case approach, the studies on the fatty acid zinc salt with highest zinc amount and lowest pH of the non-saponified free fatty acid were selected. Octanoic acid, zinc salt, basic (C8) is not irritating to the skin and zinc dilaurate (C12) is not irritating to the eye. In addition, the results of the histopathological examination of lung tissue acutely exposed to zinc dilaurate (C12) via inhalation (OECD 436 test) do not indicate an irritative potential. Furthermore, Fatty acids, C14-18 and C16-18-unsatd., zinc salts is not expected to be irritating to the skin or the eye based on the lack of respective irritation potential of zinc salts of similar-chained (C16-18) fatty acids as well as supporting information from slightly soluble/insoluble zinc compounds. Thus, a lack of skin, eye and respiratory irritancy is considered for Fatty acids, C14-18 and C16-18-unsatd., zinc salts, and classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 is not required. These conclusions are in line with conclusions for the structural analogue (i.e. Fatty acids, C16-18, zinc salts) from EU RAR “Zinc stearate (CAS# 91051-01-3, CAS# 557-05-1) Part II – Human Health. EUR 21168 EN (http://echa.europa.eu/documents/10162/08799aec-42c5-44e0-9969-baa022c66db1):

"It is consequently concluded that zinc distearate is not likely to have eye and skin irritation potential and, therefore does not need to be classified/labelled... Zinc distearate is not corrosive to skin or eyes."

A similar lack of skin and eye irritancy is considered for Fatty acids, C14-18 and C16-18-unsatd., zinc salts. For a comprehensive overview of the (non) irritancy of zinc, see the hazard assessment of "Zinc" within the framework of Regulation (EC) No 1907/2006in Appendix 1 of the CSR and cited in excerpts below.

ZINC:

Based on the available information it appears that he slightly soluble zinc oxide and insoluble zinc sulphide are not skin irritants and therefore slightly soluble zinc hydroxide, zinc phosphate, zinc carbonate and zinc metal are also expected to be not irritating to skin. Zinc oxide, zinc phosphate, zinc metal and zinc sulphide are not eye irritants and therefore zinc carbonate and zinc hydroxide are also expected to be not irritating to eyes. None of the slightly soluble or insoluble zinc compounds appear to cause respiratory tract irritation.

The slightly soluble and insoluble zinc compounds (zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal and zinc sulphide) are not corrosive based on the available irritation data.

Justification for classification or non-classification

Fatty acids, C14 -18 and C16 -18 -unsatd., zinc salts as slightly soluble/insoluble zinc compound is not irritating or corrosive based on the available irritation data. Therefore, classification is not requiredfor irritation or corrosionaccording to EC criteria outlined inCLP Regulation (EC) No 1272/2008 and Directive 67/548/EEC.