Registration Dossier

Administrative data

Description of key information

Acute toxicity via oral route:
oral  LD50 rat > 2000 mg/kg bw (OECD 401, GLP; MHLW, 2002), LD50 rat > 10000 mg/kg bw (standardized test protocol; BASF 1978).

Acute toxicity via dermal route:
Not relevant

Acute toxicity via inhalation route: 

No mortality or systemic toxicity was observed in a 7-h inhalation hazard test (IHT, BASF, 1978) and in a 5-d bioavailability study (BASF, 33I0110/91008, 1994; see section 7.5.2).

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 study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity via oral route:

For the oral exposure pathway two limit tests were available.

One OECD guideline 401 compliant study under GLP (MHLW 2002) reported no mortalities, clinical signs or necropsy findings in male and female CD rats after oral treatment with 2000 mg/kg bw per oral gavage. After an observation period of 14 d, the LD50 is > 2000 mg/kg in rats.

The second test was performed according to a standardized internal method, which is in principle comparable to the OECD guideline 401, but for which GLP compliance was not confirmed (BASF 1978). Since there were no mortalities, clinical signs or necropsy findings observed in male and female Sprague-Dawley rats dosed with 10000 mg/kg bw after a 14 d observation period, the acute oral LD50 is > 10000 mg/kg bw and the LD0 is >= 10000 mg/kg in rats.

Acute toxicity via dermal route:

No data were available for acute dermal toxicity. In accordance with Regulation (EC) 1907/2006 (REACH), the acute dermal route was waived as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >2000 mg/kg, see section 7.2.1). Additionally, no systemic effects have been observed in the in vivo studies with dermal exposure (see section 7.3.1).

Acute toxicity via inhalation route:

For the acute inhalation two studies were considered in a weight of evidence approach. An acute inhalation hazard test (IHT), performed in principle as described in the OECD Guideline 403, is available (BASF, 1978). In this study, rats were exposed for a period of 7 hours to an atmosphere saturated with vapors of the volatile components of the test substance at 20 °C. No mortality was observed during this test. Additionally, in a GLP-compliant bioavailability study, male Wistar rats were exposed for 5 days to 60 mg/m³ test substance; the observation period was 0, 3, 10, 31 and 60 d (BASF, 33I0110/91008, 1994; see section 7.5.2). No effects on mortality, clinical signs, body weights and body weight gains were found. Clearance half time was ca. 50 d in the lung; no systemic bioavailability was found in other organs. 

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. Based on the available toxicity data and the physical-chemical properties of the test substance, it is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EC) No 2016/1179.