Ethyl 3-[4-(hydroxymethyl)-2-methyl-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 Similar Substance 03 and Similar Substance 02, 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 acute toxicity of Similar Substance 02 after the oral exposure to rats 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, clinical signs, body weights were recorded and the surviving animals were necropsied. Three out of five female rats survived the single 5000 mg/kg bw oral dose. LD50 > 5000 mg/kg bw.

The acute toxicity of Similar Substance 03 via the oral route was evaluated according to the OECD Guideline 425 and OPPTS 870.1100. A single female rat was initially dosed orally at 5000 mg/kg. The animal died at day 12, therefore additional animals were dosed, one at a time, by a single ordered dose progression. The animals were observed for clinical signs and mortality for 14 days. Body weights were observed prior testing, weekly, at death and termination. All survivors were euthanised at the end of the observation period and were observed for pathological findings. The animal that did not survive experienced lethargy, wetness of the nose and mouth area, piloerection, wetness of the anogenital area, dyspnea, bloating of the abdomen, tachypnea, few feces, and emaciation. All the survivors experienced lethargy, wetness of the nose and mouth area, piloerection, wetness of the anogenital area, dyspnea, chromorhinorrehea, tachypnea, few feces, and emaciation, ataxia, diarrhea, prostration, shallow breathing and soiling of the anogenital area. Body weight loss was observed at death, while the survivors experienced body weight increase during the duration of the study. No abnormalities were observed in the gross pathology examination for the surviving animals. In the dead animal, gross necropsy findings revealed wetness of the nose/mouth area, wetness of the anogenital area, distention of the stomach and intestines, redness of the intestines, darkened kidney and enlarged adrenal gland. LD50 > 5000 mg/kg

Acute dermal toxicity

The toxicity of Similar substance 02 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.