Registration Dossier

Administrative data

Description of key information

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

Inhalation (similar to OECD 403), rat: LC50 > 1.34 mg/L 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:
5 000 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:
1 340 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 VIII, 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 VIII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Reliable studies on the potential for the test substance to cause acute oral, inhalation and dermal toxicity are available.

Oral:

The acute oral toxicity of the test substance was assessed in a study performed according to OECD Guideline 423 and in compliance with GLP (2004). A group of three fasted female Sprague-Dawley CD 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 arachis oil BP. 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. Hunched posture was noted in one animal during the day of dosing. Five animals appeared normal throughout the study and the remaining animal appeared normal one day after dosing. No abnormalities were detected at necropsy.

The acute oral LD50 cut-off of the test material (as defined in the OECD GL 423) was 5000 mg/kg bw.

Inhalation:

The acute inhalation toxicity of the test substance was assessed in a study similar to OECD Guideline 403 and performed in compliance with GLP (2004). A group of 10 Sprague-Dawley rats (5/sex) was exposed to the test substance as a dust. The animals were exposed for four hours using a nose-only exposure system, followed by a fourteen-day observation period. The mean achieved atmosphere concentration was 1.34 mg/mL which was the mean maximum attainable concentration. The mean mass median aerodynamic diameter was 4.84 µm with a geometric standard deviation of 2.77. No animal died during this study and all the animals showed normal bodyweight development. Common abnormalities noted in all the animals until 1 h after exposure ended, included increased respiratory rate, hunched posture, pilo-erection and wet fur and there were an isolated instance of fur staining by the test material. Four of six animals recovered quickly to appear normal by day 1, while an increased respiratory rate and hunched posture persisted in 2/6 animals and gradually became less severe until Day 5 post-exposure. No abnormalities were detected at necropsy.

The acute inhalation LC50 was considered to be greater than 1.34 mg/L air (analytical).

Dermal:

The acute dermal toxicity of the test substance was assessed in a study performed according to OECD Guideline 402 and in compliance with GLP (2004). A group of ten animals (five males and five females Sprague Dawley rats) was given a single, 24-hour, semi-occluded dermal application of the test material to intact skin at a dose level of 2000 mg/kg bodyweight. 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 signs of systemic toxicity and 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.

This finding is further supported by a supporting study done similar to OECD Guideline 402 but not in compliance with GLP. There was no mortality, and no clinical signs of toxicity were observed. No skin irritation was noted at the test site and not treatment-related changes were observed at necropsy. In this study a LD50 of greater than 2000 mg/kg bw was observed.

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.