Registration Dossier

Administrative data

Description of key information

The oral LD50 for rats was determined to be >2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 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 study available

Additional information

Acute oral toxicity

No information on acute toxicity of Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates was identified. However, one study from a structural analogue is available.

The acute oral toxicity of the test substance Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744-23 -9) to male and female Sprague-Dawley rats was investigated in an OECD 401 limit test under GLP conditions. The test substance was given to five animals per sex in a single dose of 2000 mg/kg bw. Animals were examined for clinical signs up to 6 hours after the treatment. Thereafter, animals were daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14 day observation period all animals were subjected to necropsy. During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2000 mg/kg bw).

Justification for classification or non-classification

Based on the available information, classification for acute toxicity is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.