Registration Dossier

Administrative data

Description of key information

An acute oral LD50 > 5000 mg/kg bw in female rats was determined for the test substance. 
An acute dermal LD50 > 5000 mg/kg bw in rats was determined for the test substance.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 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:
discriminating dose
Value:
5 000 mg/kg bw

Additional information

Due to a lack of experiments with the test substance and the existence of a structural analog (read-across substance) part of or the complete data was derived from the read-across substance. For details on the read-across reliability please refer to IUCLID Section 13. 

 

Acute oral toxicity

In a study of acute oral toxicity conducted according to OECD 423 the read-across substance Bis(2-propylheptyl) hexanedioate was administered to 3 female rats. The animals received 5000 mg/kg bw read-across substance once and were observed for 14 days. No mortality occurred. Impaired general state an. d piloerection at hour 2 and 3 and on day 9 after administration was observed in one animal. The body weight of all animals increased throughout the study period within the normal range. There were no macroscopic pathological findings. Due to these findings the read-across was determined to have an LD50 > 5000 mg/kg bw in female rats.

Another study with the read-across substance Bis(2-propylheptyl) hexanedioate was conducted according to OECD 423. The 6 female rats were treated once with 2000 mg/kg bw of the read-across substance. No mortality occurred in the 14 day observation period. No clinical signs were observed during clinical examination. The mean body weight of the test groups increased throughout the study period within the normal range. Therefore an LD50 of more than 2000 mg/kg bw for female rats was established.

 

Acute dermal toxicity

An acute dermal toxicity study according to OECD 402 was conducted. Five male and female rats were treated with 5000 mg/kg bw of the read-across substance Bis(2-propylheptyl) hexanedioate under semiocclusive conditions. The animals were exposed for 24 h and afterwards observed for 14 days. No mortality was observed and no local or systemic clinical signs were detected. The body weights increased in the normal range and no abnormalities were found during pathological analysis. An LD50 > 5000 mg/kg bw for rats was determined.


Justification for selection of acute toxicity – oral endpoint
most reliable study from read-across substance

Justification for selection of acute toxicity – dermal endpoint
most reliable study from read-across substance

Justification for classification or non-classification

Based on the available acute oral and dermal toxicity data from the read-across substance, the test substance does not have to be classified for acute toxicity according to Regulation (EC) No 1272/2008 (CLP/GHS) as amended for the seventh time in Regulation (EC) No 2015/1221. The test item does not meet the criteria for specific target organ toxicity after single exposure (STOT SE) according to Regulation (EC) No 1272/2008 (CLP/GHS) as amended for the seventh time in Regulation (EC) No 2015/1221.