Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate

Endpoint summary

Description of key information

LD50 (oral) > 5000 mg/kg bw

LD50 (dermal) > 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:

LD50

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:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute toxic effects of the substance via the oral and dermal route were evaluated by the use of an analogous substance, due to the absence of available data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.

Acute oral toxicity

The toxicity of the test material to rats after their single, acute dermal exposure to the substance was evaluated in a limit test according to the OECD Guideline 425 and EPA OPPTS 870.1100 and n compliance with GLP. Initially, one healthy female Sprague Dawley rat was dosed orally at 5000 mg/kg bw. Since the animal survived, four additional animals were dosed at 5000 mg/kg bw. The animals were observed for 14 days for mortality and clinical signs, body weight changes and the survivors were necropsied. Three out of five female rats survived the single 5000 mg/kg bw oral dose. LD50 > 5000 mg/kg bw.

Acute dermal toxicity

The toxicity of the test material to rats after their single, acute dermal exposure to the substance was evaluated in a limit test according to the OECD Guideline 402 and EU Method B.3 and in compliance with GLP. Five male and five female Wistar rats were dermally exposed to a single dose of the substance at 2000 mg/kg bw. The test substance was held in contact with the skin with a semi-occlusive dressing which was removed after 24 hours of exposure. The animals were observed for 15 days for mortality, clinical signs, body weight changes and necropsy were conducted after the end of the study. No mortality was observed. Chromodacryorrhoea of the snout was noted for one male and two females on Day 1 while pelvic dilation of the kidney was noted for a single male. This necropsy finding is commonly noted among rats of this age and strain and was therefore considered not toxicologically significant. LD50 > 2000 mg/kg bw

Justification for classification or non-classification

For the evaluation of the classification of the substance the lethal doses (LD50) from both oral and dermal acute toxicity studies are considered.

Both LD50s are higher than the threshold for classification (i.e. LD50>2000 mg/kg bw), as indicated in the CLP Regulation (EC) No. 1272/2008 and therefore the substance is not classified for acute toxicity.