Registration Dossier

Administrative data

Description of key information

The oral LD50 value was 100 mg/kg for rats. General anesthetic, somnolence, and ataxia was observed.

However, in the dissemination view on the ECHA website of the full registration dossier a GLP-compliant Guideline study, conducted in 2010, comprised an acute oral LD50 value between 300 and 2000 mg/kg bw in rats.

In an inhalation study, no mortality was observed at a concentration of 12 g/m³ for 4 hours. Exciting behavior, conjunctive irritation, and weight loss or decreased weight gain were observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
GLP compliance:
no
Sex:
not specified
Dose descriptor:
LD50
Effect level:
100 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
100 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1989
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
GLP compliance:
no
Species:
rat
Duration of exposure:
4 h
Dose descriptor:
LCLo
Effect level:
> 12 mg/L air
Clinical signs:
Exciting behavior, conjunctive irritation
Body weight:
weight loss or decreased weight gain
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating conc.
12 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

In a study on acute oral toxicity, the oral LD50 value was 100 mg/kg for rats. General anesthetic, somnolence, and ataxia was observed. (NTIS, 1989)

However, in the dissemination view on the ECHA website of the full registration dossier a GLP-compliant Guideline study, conducted in 2010, comprised an acute oral LD50 value between 300 and 2000 mg/kg bw in rats. (ECHA Dissemination View, accessed on 2018-09-27)

Rusin et al. determined an oral LD50 value of 700 mg/kg bw (1958). Additionally, the Toxic Substances Control Act provides several literature data on acute oral toxicity. LD50 values for rat of 50.0 - 400.0 mg/kg bw (1992) and 100.0 - 200.0 mg/kg bw (1984) and for mice of 200.0 - 400.0 mg/kg bw (1984) are reported. In another literature source, an approximately lethal dose (ALD) of 450.0 mg/kg bw for female rats and of 670.0 mg/kg bw for male rats was determined (1962).

Acute inhalation toxicity

In an inhalation study, no mortality was observed at a concentration of 12 g/m³ for 4 hours during a 14 days observation period. Exciting behavior, conjunctive irritation, and weight loss or decreased weight gain were observed. (NTIS, 1989)

IGW Elberfeld examined the acute inhalation toxicity with an aerosol of the substance in different species. After an exposure duration of 8 h, all mice died within a few days after single or repeated (2 - 3 times) exposure. No deaths occurred among rats, rabbits and cats.

Rusin et al. determined an inhalative LC50 of 0.7 g/kg for mice that were exposed to an aerosol of the substance (1958).

Additionally, the Toxic Substances Control Act provides several literature data on acute inhalative toxicity. An approximately lethal concentration (ALC) of 950 mg/m³ for rats after an exposure of 4 h was determined (1992).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The oral LD50 was 100 mg/kg for rats. However, in the dissemination view on the ECHA website of the full registration dossier a GLP-compliant Guideline study, conducted in 2010, comprised an acute oral LD50 value between 300 and 2000 mg/kg bw in rats.

No mortality but exciting behavior, conjunctive irritation, and weight loss or decreased weight gain were observed in an inhalation study at a concentration of 12 g/m³. As a result and according to Annex VI (index number 608-019-00-1) the substance is considered to be classified for acute oral toxicity Category 4 and acute inhalation toxicity Category 4 under Regulation (EC) No. 1272/2ßß8, as amended for the tenth time in Regulation (EC) No. 2017/776.