Registration Dossier

Administrative data

Description of key information

Acute oral toxicity

The LD50 of the acute oral toxicity was determined to be > 2000 mg/kg bw.

 

Acute dermal toxicity

Based on the absence of mortality, the acute dermal LD50 was determined to be > 2000 mg/kg bw.

 

Acute inhalation toxicity

In the acute inhalation toxicity test, no mortality was observed, therefore the LC50 was found to be > 5.48 mg/L.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating conc.
Value:
5 480 mg/m³
Quality of whole database:
GLP and guideline compliant

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant

Additional information

Key study: Acute oral toxicity 2010/1231357

In an acute oral toxicity study, three young adult female Wistar (Jcl:Wistar) rats were given an oral dose via gavage of the test substance suspended in 0.5 w/v% methylcellulose solution at a dose levels of 300 mg/kg (two dose groups of 3 animals each) and 2000 mg/kg bw (two dose groups of 3 animals each) (Batch: 080722; Purity: 95.74%). Animals were observed for 14 days.

After administration of 300 mg/kg (first and second step), 2000 mg/kg bw (third and fourth step) of the test substance, all animals survived until the termination of the study. Accordingly, the oral LD50 was found to be greater than 2000 mg/kg bw. No clinical signs were noted in any of the dose groups in the study. All animals gained body weight on days 7 and 14 after administration. No macroscopic abnormalities were noted in any animal at necropsy at the end of the observation period.

Accordingly, the oral LD50 was > 2000 mg/kg bw.

 

Key study: Acute dermal toxicity 2009/1130542

In an acute dermal toxicity study, one group of 5 male and 5 female Wistar rats were exposed to a single dermal dose of 2000 mg/kg of the test substance (Batch:080722; Purity: 95.74%) to the clipped, dorsal skin area under semi-occlusive conditions for 24 hours. The animals were observed for 14 days after administration. There were no dermal responses, clinical signs, macroscopic abnormalities or altered bodyweight parameters.

Based on the absence of mortality, the acute dermal LD50 was determined to be > 2000 mg/kg bw.

 

Key study: Acute inhalation toxicity 2010/1231352

Wistar rats (5 males and 5 females) were exposed to the test substance for 4 hours at a concentration of 5.48 mg/l (maximum attainable concentration; nose only) and were observed for 14 days. The mass median aerodynamic diameter (MMAD) of the test aerosol was 4.30 μm. A vehicle control group (1.31 mg/L for white carbon) was conducted with 5 males and 5 females.

With no observed mortality, the LC50 was found to exceed 5.48 mg/l.

Justification for classification or non-classification

Acute oral toxicity

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.

Acute dermal toxicity

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 was greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute dermal toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.

Acute inhalation toxicity

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LC50 was greater than 5.48 mg/L. As a result the substance is not considered to be classified for acute inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the eighth time in Regulation (EU) No 2016/918.