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Administrative data

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 dermal route and via the oral route were evaluated by the use of data on Similar Substance 02 and also on the substance itself, due to the absence of available data (for acute dermal toxicity) 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, two additional animals were dosed at 5000 mg/kg bw. Animals were observed at 15 minutes, 1, 2 and 4 hours post dose and once daily for 14 days for toxicity and pharmacological effects. Animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination. All animals were humanely sacrificed using CO2 following study termination and examined for gross pathology. No mortality was observed. LD50 > 5000 mg/kg bw.

The acute oral 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.

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 was 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.