Glycerides, C12-18 mono-, di- and tri-

Endpoint summary

Link to relevant study record(s)

Reference

Endpoint:

basic toxicokinetics, other

Data waiving:

other justification

Justification for data waiving:

other:

Description of key information

No specific toxicokinetic studies are available on Glycerides, C12-18 mono-, di- and tri-. A toxicokinetic assessment was made based on the physico-chemical properties of the test substance and the results of toxicity studies (acute oral toxicity, repeated oral dose toxicity study, skin irritation, eye irritation, skin sensitization and in vitro genotoxicity).

Additional information

Physico-chemical properties:

Water solubility: 17.2 mg/L (at 20°C)

Partition coefficient in octanol/water: The study will be available December 2018.

Melting point/freezing point: 29.75°C (at 101.325 kPa)

Boiling point: 400.8°C (at 101.325 kPa)

Density: 0.9802 (at 20°C)

Flammability: This substance is not a highly flammability solid.

 

Absorption:

Oral route:

This is UVCB organic substance with uncertain structure, molecular weight and particle size and so on. The results obtained in the acute toxicity: oral study (OECD 401) and the repeated oral dose toxicity study (OECD 422) confirmed the oral absorption of Glycerides, C12-18 mono-, di- and tri- as no adverse effect observed in both studies. Therefore it can be considered that the absorption resulting from potential exposure by the oral route is limited.

 

Inhalation:

No data are available for inhalation route of exposure. However, the test substance is a solid and exposure via inhalation is not likely taking into account. Therefore it can be considered that the absorption resulting from potential exposure by the inhalation route is limited.

 

Dermal route:

No data are available for dermal route of exposure. However, the test substance is a solid and skin contact in production and use is not likely. Also there is no adverse effect observed in the studies of skin irritation, skin sensitization and eye irritation. Therefore it can be considered that the absorption resulting from potential exposure by the dermal route is limited.

 

Distribution:

In the acute oral toxicity study, no mortality and no overt signs of toxicity were noted as well as no abnormalities were noted at necropsy of animals killed at the end of the study. In the repeated dose oral toxicity study, no toxicologically relevant changes were noted in organ weights and organ to body weight ratios as well as no effects observed in clinical signs, mortality, haematological findings. These results indicate no specific systemic distribution of the test substance and/or its metabolites or degradation products.

 

Metabolism:

In the acute oral toxicity study and the repeated dose oral toxicity study, no adverse effect is observed. Also in the study of in vitro cytogenicity/chromosome aberration in mammalian cells, no genotoxicity and no cytotoxicity are observed. In the absence of specific metabolism studies, it is not possible to conclude on the metabolisation potential of the substance, but according to the studies above, there seems no adverse effect of the substance and/or its metabolites or degradation products.

 

Excretion:

There is no indication of a preferred route of excretion for Glycerides, C12-18 mono-, di- and tri- but its water solubility of 17.2 mg/L (at 20°C) and no adverse effect in oral toxicity studies indicates that excretion of unchanged parent substance and/or metabolites could occur by renal or biliary routes and that bioaccumulation is unlikely.