Glycerides, C16-18

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 4 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 3 000 mg/kg bw

Additional information

Acute oral toxicity

A study was conducted to determine the acute oral toxicity potential of the constituent glycerides, C8 -18, and C18 -unstad. (coconut oil) according to an unspecified method. Under the study conditions, the oral LD50 of test substance in rats is greater than 5,000 mg/kg bw (Biotech Index, 1970).

A study was conducted to determine the acute toxicity potential of the constituent glycerides, C8 -18 and C18 -unsatd. (coconut oil) in rats. In this study, 26 mL/kg bw (23,500 mg/kg bw) of ‘glycerides, C8-18 and C18-unsatd.’ (as coconut oil) was orally administered to 10 rats. No mortality was observed. Under the test conditions, the oral LD50 of the test substance in rats can be considered to be greater than 23,500 mg/kg bw (IUCLID, 2000).

An acute oral toxicity was conducted with the constituent glycerides, C16 -18 and C18 -unsatd. (palm oil). The test substance was administered at a dose of 5,000 mg/kg to 5 rats. Two moratlities were reported on Day 2 and 6. Therefore, under the study conditions, the acute oral LD50 of the test substance in rats was considered to be greater than 5,000 mg/kg bw (CTFA, 1978).

A study was conducted to evaluate the acute oral toxicity of the constituent ‘glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy’ (as castor oil) in rats in accordance with OECD Guideline 401, 1987 and to GefStoffV, Aug. 26th, 1986, (BGBI 1470). A group of 5 fasted male and female Wistar rats were exposed to a single oral dose of 5 mL/kg bw. Clinical signs and mortality were recorded during the 14 day observation period. Necropsy was conducted on moribund animals and those terminated at test end. No clinical signs and no mortality were observed. There were no treatment-related effects on body weight and nothing abnormal was found in the animals necropsied on Day 14. Under the study conditions, the acute oral LD50 of the test substance was considered to be >5 mL/kg (equivalent to 4,952 mg/kg bw) (Chibanguza, 1988).

The acute oral toxicity of ‘glycerides, C16-18 and C18-unsatd.’ (as linseed oil) was investigated in rats in accordance with OECD Guidenile 401 and EG 84/449/EWG. A single dose of 4,763 mg/kg bw of the test substance was administered to 5 male and 5 female rats. Clinical signs, body weights and mortalities were recorded during the 14 day observation period. Immediately after death or at the end of the observation period, a complete necropsy was performed. No mortality or any other adverse effect was observed in any of the animals. Under the study conditions, the acute oral LD50 of the test substance in rats was found to be greater than 4,763 mg/kg bw. (Chibanguza, 1988).

Acute dermal toxicity:

A study was conducted to determine the acute dermal toxicity of the constituent glycerides, C8 -18 and C18 -unsatd. (in the form of fully hydrogenated coconut oil) in guinea pigs. The test substance was applied at a dose of 3,000 mg/kg bw to the skin of 12 guinea pigs. No mortality occurred during the 7 d observation period. Under test conditions, the LD0 of the substance in guinea pigs was found to be 3,000 mg/kg bw (CIR, 1986).

Justification for classification or non-classification

No acute toxicity studies were located for ‘glycerides, C16-18 (SDA Reporting Number: 19-001-00)’. However, acute toxicity studies for other substances of the same read across category indicate low acute oral and dermal toxicity, with overall LD50 values > 3,000 mg/kg bw. Further, these substances have a long history of safe use in a wide range of nutritional (food and feed), cosmetic and industrial applications.

Exposure via the inhalation route is not expected given the physical state (solid at ambient temperature) and low vapour pressure of ‘glycerides, C16-18 (SDA Reporting Number: 19-001-00)’.In many cases the substance is also used in industrial applications and transported and handled in liquid form (heated). If the substance is handled in powder form, sprayed or otherwise finely dispersed in the air, the use of appropriate risk management measures (e.g. filter mask) is recommended.In addition, studies conducted via the oral and dermal routes indicate a lack of significant toxicity of the test material.  

Based on the above information, the substance does not require classification for acute oral, dermal or inhalation toxicity according to EU CLP regulation (EC) 1272/2008.