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Administrative data

Description of key information

Oral (OECD 423), rat: LD50 > 2000 mg/kg bw (LD50 cut-off value = 5000 mg/kg bw according to OECD 423)

Inhalation (OECD 403), rat: LC50 > 5000 mg/m3 air

Dermal (OECD 402), rat: LD50 > 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:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5 000 mg/m³
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Reliable studies regarding acute oral, inhalation and dermal toxicity are available for the test substance.

 

Oral:

The acute oral toxicity of the test substance was assessed in a study performed according to OECD 423 and in compliance with GLP (M-001078-01-2, 2004). A group of three fasted female Wistar rats was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females treated with the same dose level. The test material was administered by gavage as a suspension in water with 2% Cremophor (polyethoxylated castor oil). The animals were observed for 14 days. There were no deaths and all the animals showed the expected gains in bodyweight over the study period. No abnormalities were detected at necropsy.

The acute oral LD50 value of the test material was therefore > 2000 mg/kg (LD50 cut-off according to OECD 423).

Inhalation:

The acute inhalation toxicity of the test substance was assessed in a study according to OECD 403 and performed in compliance with GLP (M-121743-01-2). A group of 10 Wistar rats (5/sex) was exposed to the test substance as a dust. The animals were exposed for 4 h using a nose-only exposure system, followed by a 14-day observation period. The mean achieved atmosphere concentration was 5030 mg/m3which was the mean maximum attainable concentration. The mean mass median aerodynamic diameter was 5.93 µm with a geometric standard deviation of 1.88 and therefore small enough for particles to be inhalable. No animal died during this study. Clinical signs were ungroomed coat and piloerection, which were observed on the day of treatment and the following two days only. Approximately 30 minutes after the inhalation period body temperatures were slightly but statistically significantly decreased. However, this was considered to be an indirect evidence of a mild respiratory tract sensory irritation possibly through desiccating the mucous membranes of the upper respiratory tract due to the high dust loading and was therefore not indicative of a toxic effect. There were no effects on body weight or body weight gain.

No abnormalities were detected at necropsy.

The acute inhalation LC50 was considered to be greater than 5000 mg/m3air (analytical).

 

Dermal:

The acute dermal toxicity of the test substance was assessed in a study performed according to OECD 402 and in compliance with GLP (M-001029-01-2). A group of ten 10 Wistar rats (5/sex) was given a single, 24-hour, semi-occluded dermal application of the test material to intact, shaven skin at a dose level of 2000 mg/kg bw. The animals were observed for 14 days. There were no mortalities or clinical signs of toxicity. Body weight and body weight gain in males were unaffected. One female showed decreased body weight on day 15.

No signs of dermal irritation were observed. No abnormalities were noted at necropsy.

The acute dermal LD50 of the test material was found to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The available data on acute oral, inhalation and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.