Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
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 adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

The acute oral toxicity of the test item was investigated in 5 female and 5 male rats using purified water as vehicle. The study was performed according to OECD test guideline 401 and followed the principles of GLP. All animals were administered the test compound by single-dose gavage at a dose-level of 2000 mg/kg body weight. The observation period was 14 days. No deaths occurred during the study. Clinical signs of intoxication were also not observed during the course of the study. Body weight development was normal and within the range commonly recorded for this strain and age. At necropsy no macroscopic findings were recorded. Based on the findings of this limit-test the median lethal dosage (LD50) of the test item in male/female rats is greater than 2000 mg/kg body weight.

The acute dermal toxicity of glycerin was tested in a method equivalent to the OECD 402 guideline. No adverse effects were observed. The same can be expected for polyglycerin.


Justification for selection of acute toxicity – oral endpoint
Guideline study performed according to GLP

Justification for classification or non-classification

Based on the results from an available guideline study, the registered substance is not subject to labelling and classification requirements with regard to the oral and dermal route of exposure.