Registration Dossier

Toxicological information

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Skin sensitisation:

A registration dossier shall contain information on the human health hazard assessment (regulation 1907/2006, Art.10). However, it is considered that the information requirements for tall oil as laid down in annex VII to IX can be fulfilled by adaptation of the standard testing regime according to Annex XI, points 1.2. and 1.3. as presented in the following:

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.

The substance subjected to registration is a mixture of different saturated and unsaturated C16 -C18 fatty acids. Based on this, the following endpoint is covered by publicly available data on fatty acids with the same or similar structure.

 

Based on human and animal data the HERA document on fatty acid salts (2002) reported that β€œin 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. 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. In two Magnusson and Kligman guinea pig maximisation tests, carried out in conformity with OECD Guideline No. 406 and EC test method B.6 as described in the Annex of EC Directive 84/449/EEC, using two different types of mixed fatty acid sodium salts, no skin sensitisation potential was demonstrated in either material (CIR, 1982)" (HERA, 2002).

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

 

References:

CIR (1982) Final report of the safety assessment of lithium stearate, aluminum distearate, aluminum stearate, aluminum tristearate, ammonium stearate, calcium stearate, magnesium stearate, potassium stearate, sodium stearate, and zinc stearate. JACT, 1(2): 143-177.

De Groot, A.C., Van Der Meeren, H.L.M. and Weyland, J.W. (1988) Cosmetic allergy from stearic acid and glyceryl stearate. Contact Dermatitis, 19(1): 77-78.

Human & Environmental Risk Assessment (HERA) on ingredients of European household cleaning products- Fatty Acid Salts, Draft for Public Comment, June 2002

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification