Fatty acids, tall-oil, manganese salts

Endpoint summary

Description of key information

No skin sensitisation study with fatty acids, tall-oil, manganese salts is available, thus the skin sensitisation potential will be addressed with existing data on the individual moieties manganese and tallate.

Fatty acids, tall-oil, manganese salts is not expected to show signs of dermal sensitisation, since the two moieties manganese and tallate have not shown any skin sensitisation potential in experimental testing. Additionally, the moiety fatty acids, tall-oil is obtained from natural sources and excluded from the obligation to register.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Read-across approach

Selected endpoints for the human health hazard assessment are addressed by read-across, using a combination of data on the metal cation and the organic acid anion. This way forward is acceptable, since metal carboxylates are shown to dissociate to the organic anion and the metal cation upon dissolution in aqueous media. No indications of complexation or masking of the metal ion through the organic acid were apparent during the water solubility and dissociation tests (please refer to the water solubility and dissociation in sections 4.8 and 4.21 of IUCLID). Once the individual transformation products of the metal carboxylate become bioavailable (i.e. in the acidic environment in the gastric passage or after phagocytosis by pulmonary macrophages), the “overall” toxicity of the dissociated metal carboxylate can be described by a combination of the toxicity of these transformation products, i.e. the metal cation and carboxylate anion according to an additivity approach.

Fatty acids, tall-oil, manganese salts is the manganese metal salt of fatty acids, tall-oil, which readily dissociates to the corresponding divalent manganese cation and tallate anions. The manganese cation and the tallate anions are considered to represent the overall toxicity of Fatty acids, tall-oil, manganese salts in a manner proportionate to the free acid and the metal (represented by one of its readily soluble salts). 

A detailed justification for the read-across approach is added as a separate document in section 13 of IUCLID.

 

Sensitisation

No skin sensitisation study with Fatty acids, tall-oil, manganese salts is available, thus the skin sensitisation potential will be addressed with existing data on the dissociation products as detailed in the table below. Further details on the skin sensitisation potential of the individual constituents within the framework of regulation (EC) 1907/2006 are given below.

 

Table: Summary of skin sensitisation data of Fatty acids, tall-oil, manganese salts and the individual constituents.

	Manganese ion	Fatty acids, tall-oil	Fatty acids, tall-oil, manganese salts (CAS# 8030-70-4)
Skin sensitisation	not sensitising	not sensitising	not sensitising (read-across)

 

 

Manganese

No classification of manganese is based on two negative LLNA studies on manganese chloride and upon lack of any sensitisation with a 75/80% MnSO4 solution (mixed with NiSO4) in human patch tests.

 

Tallate

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 “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. 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.

 

Fatty acids, tall-oil, manganese salts

Fatty acids, tall-oil, manganese salts is not expected to show signs of dermal sensitisation, since the two moieties manganese and tallate have not shown any skin sensitisation potential in experimental testing. Thus, fatty acids, tall-oil, manganese salts 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.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Fatty acids, tall-oil, manganese salts is not expected to show signs of dermal sensitisation, since the two moieties manganese and tallate have not shown any skin sensitisation potential in experimental testing. Additionally, the moiety fatty acids, tall-oil is obtained from natural sources and excluded from the obligation to register. Thus, fatty acids, tall-oil, manganese salts is not to be classified according to regulation (EC) 1272/2008 as skin sensitising.