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Administrative data

Description of key information

Based on a study according to OECD Guideline 423 in rats the oral LD50 of the test item was determined to be > 2000 mg/kg bw.

Based on a study according to OECD Guideline 402 in rats the dermal LD50 of the test item was determined to be > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
Value:
200 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:
2 000 mg/kg bw

Additional information

Acute toxicity: oral

A study was performed to assess the acute oral toxicity of the test item in the rat according to OECD 423 and EU Method B. 1. There were no deaths in a group of six rats (three males and three females) that received a single oral gavage dose of the test substance, formulated in distilled water, and administered at a dose level of 200 mg/kg bodyweight. To further define the toxic potential of the test substance and in accord with the test criteria an additional group of six fasted rats (three males and three females) were similarly treated with the test substance at a dosage of 2000 mg/kg bodyweight. Clinical signs of reaction to treatment comprised piloerection and hunched posture notable in all rats treated at 200 or 2000 mg/kg, with waddling/unsteady gait and dark colouring to eyes in all rats at 2000 mg/kg, soft to liquid faeces and ungroomed appearance in one male and all females at 2000 mg/kg and protruding eyes in all females at 200 mg/kg and one female at 2000 mg/kg. Recovery was complete in all instances by Day 6. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were revealed at the macroscopic examination at study termination on Day 15. The acute lethal oral dose (LD50) to rats of the test item was demonstrated to be > 2000 mg/kg bodyweight.

 

Acute toxicity: dermal

In an acute dermal toxicity study (limit test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw (dose adjusted to purity) of the test item (as suspension in corn oil Ph.Eur). The clipped application site (dorsal and dorso-lateral parts of the trunk, comprising at least 10% of the total body surface) was covered by semi-occlusive dressing during the 24-hour exposure period. The animals were observed for 14 days No mortality occurred. No signs of systemic toxicity or skin effects were observed. The body weight of the animals increased within the normal range throughout the study period with one exception in the female group. In one animal the body weight increased normally during the first week, but showed only a slight weight gain during the second week. Due to the fact that stagnation of body weight is commonly known for females after dermal applications, this stagnation is considered to be unspecific. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Classification, Labeling, 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 oral and dermal LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.