Addition reaction products of conjugated sunflower-oil fatty acids and tall-oil fatty acids with maleic anhydride

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

expert statement

Type of information:

other: expert statement

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: expert statement based on available study results

Data source

Reference

Reference Type:

other: expert statement

Title:

Unnamed

Year:

2019

Materials and methods

Test material

Test material information

Constituent 1

Test material form:

liquid: viscous

Applicant's summary and conclusion

Executive summary:

No specific study was performed on the absorption, distribution, metabolism, excretion (ADME) of this substance (WS400104), but data currently available on physical-chemical properties and from in vivo toxicology studies were evaluated.

The substance WS400104 is a complex mixture of components, addition products of conjugated sunflower-oil fatty acids with tall oil fatty acids and maleic anhydride. The neat substance (as used in the laboratory tests) is a light brown/yellow viscous liquid. For industrial and professional uses, the substance always is formulated in organic solvents.

Molecular weights of the different constituents amount to approx. 340 Da. Water solubility of the UVCB substance is low (less than 8 mg/L at 20°C). The water/octanol partition coefficient is below 1.

Based on its physical-chemical properties, absorption after oral exposure is expected. In the sub-chronic repeated oral dose toxicity study some effects were observed in the livers of female rats at the highest dose level of 600 mg/kg body weight/day. No adverse systemic effects were observed in high dose males and in animals of both sexes at lower doses. In animals of the mid and high dose levels, local irritation of the non-glandular part of the stomach was observed.

Systemic availability of WS400104 after dermal application is expected to be low, based on the low water solubility and relatively high molecular weights. In the skin sensitisation test in mice (LLNA), skin sensitisation was observed. In the in vitro test for skin irritation, an irritating potential was observed. From these observations it is concluded that at least small amounts of the UVCB substance can penetrate the skin.

Inhalation exposure to WS400104 is unlikely, because it has a very low vapour pressure (1.3 x 10E-3 Pa at 25°C) limiting its availability under a vapour state, and because it is a highly viscous liquid limiting its availability as an inhalable aerosol.

There is no information on metabolism or excretion of WS400104.

Based on the octanol water partition coefficient, bioaccumulation of WS400104 in aquatic organisms is not likely. The bioaccumulation potential in mammals also is expected to be low based on the currently available information.