Registration Dossier

Administrative data

Description of key information

Based on the results of the read across study, the oral LD50 value of the test substance is considered to be 2623 mg a.i./kg bw, indicating a low toxicity potential..

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 623 mg/kg bw
Quality of whole database:
Guideline compliant study

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

A study was conducted to determine the acute oral toxicity of the read across substance, mono- and di- C12 PSE, K+, according to OECD guideline 401 (standard acute method). The test substance was administered by gavage to ten female Wistar rats at concentrations of 0, 6300, 8000, 9000, 10000, 12500 and 15000 mg/kg bw (25%, in water). The duration of the observation period following administration was 14 days. Clinical observations were recorded after application and weighing once per week. Macroscopic examination was performed on all animals. Mortality occurred in the groups 10000, 12500 and 15000 mg/kg bw (5, 9 and 10/10, respectively). Mortally poisoned animals died within 1-2 days after application. Disturbance of equilibrium and spasm were observed. The test substance was expelled by vomiting. Normal body weight gain was recorded in all surviving animals. Dissection of rats killed at the end of the observation period revealed no macroscopic findings. Necropsy of the deceased animals revealed the following macroscopic findings: stomach and oesophagus were filled with white foam. Based on the results of the read across study, the female rat LD50 of the test substance was considered to be 10490 mg/kg bw, corresponding to 2623 mg a.i./kg bw (Hollander,1974).

Justification for classification or non-classification

Based on the results of a read across acute oral toxicity study, the test substance does not meet the criteria for classification for this endpoint according to CLP (Regulation 1272/2008/EC) criteria.