Registration Dossier

Administrative data

Description of key information

The oral LD50 was determined to be >2000 mg/kg bw for the two structural analogues of Isosorbide Monooleate.

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
Quality of whole database:
Weight of evidence approach applied.

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 toxicity: oral

There are no acute oral toxicity studies available for Isosorbide Monooleate (CAS 28454-96-8). Therefore two studies performed with different structural analogues are used in a weight of evidence approach.

The first study (BASF SE, 2001) is performed with Isosorbide (CAS 652-67-5). In this GLP compliant study, performed in accordance with OECD guideline 401 and 420, 6 Sprague-Dawley rats per sex per dose received the test substance via oral gavage. The animals were exposed to 0 or 2000 mg/kg bw dissolved in water. After an observation period of 14 days animals were necropsied. No mortality and behavior modification occurred during the study following the oral administration of the test substance. No abnormality was observed at necropsy. Body weight evolution, feed and water consumption of treated animals were comparable to those of the controls. The LD50 was determined to be >2000 mg/kg bw.

The second study (BASF SE, 2008) is performed with Isosorbide Diesters (EC 700-073-5). In this GLP compliant study, performed in accordance with OECD guideline 401, 5 Sprague-Dawley rats per sex per dose received the test substance via oral gavage. The animals were exposed to 0, 290, 575, 1150, and 2300 mg/kg bw of test substance dissolved in water, corresponding with 0, 250, 500, 1000, and 2000 mg/kg bw of the active ingredient (Isosorbide Diesters). After an observation period of 14 days animals were necropsied. No mortality or clinical observations were observed. Body weight gain in the dosed groups was comparable to the control group. The LD50 was determined to be >2000 mg/kg bw.

As the LD50 was determined to be >2000 mg/kg bw for both structural analogues, the LD50 for Isosorbide Monooleate (CAS 28454-96-8) is also expected to be >2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.