Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 (male and female rats) > 2000 mg/kg bw (OECD 401; GLP compliant)

Acute inhalation toxicity: LC50 (male and female rats) > 5.04 mg/L air (analytical)(OECD 403, GLP compliant)

Acute dermal toxicity: LD50 (male and female rats) > 2000 mg/kg bw (OECD 402; GLP compliant)

Key value for chemical safety assessment

Additional information

Acute oral toxicity

One reliable animal study described in Ullmann (1989)(OECD 401; GLP complaint) is considered to be reliable without restrictions. The LD50 was determined to be greater than 2000 mg/kg bw.

Acute inhalation toxicity

One reliable animal study described in Duchosal (1989)(OECD 403; GLP complaint) is considered to be reliable without restrictions. The LC50 was determined to be greater than 5.04 mg/L air (analytical).

Acute dermal toxicity

One reliable animal study described in Ullmann (1989)(OECD 402; GLP complaint) is considered to be reliable without restrictions. The LD50 was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

Acute oral toxicity

Reference Ullmann (1989) is considered as the key study for acute oral toxicity and will be used for classification. The LD50 was determined to be greater than 2000 mg/kg bw. Thus, according to regulation (EC) 1272/2008 and subsequent amendments the substance does not have to be classified.

Specific target organ toxicant (STOT) - single exposure: oral

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value, oral for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification required.

Acute inhalation toxicity

Reference Duchosal (1989) is considered as the key study for acute inhalation toxicity and will be used for classification. The Lc50 was determined to be greater than 5.04 mg/L air (analytical). Thus, according to regulation (EC) 1272/2008 and subsequent amendments the substance does not have to be classified.

Specific target organ toxicity (STOT) - single exposure: inhalation

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, inhalation are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, inhalation for a Category 1 classification (C ≤ 1.0 mg/L/ 4 h) and at the guidance value, inhalation for a Category 2 classification (5.0 mg/L/ 4 h ≥ C > 1.0 mg/L/ 4h). No classification required.

Acute dermal toxicity

Reference Ullmann (1989) is considered as the key study for acute dermal toxicity and will be used for classification. The LD50 was determined to be greater than 2000 mg/kg bw. Thus, according to regulation (EC) 1272/2008 and subsequent amendments the substance does not have to be classified.

Specific target organ toxicant (STOT) - single exposure: dermal

The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, dermal are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, dermal for a Category 1 classification (C ≤ 1000 mg/kg bw) and at the guidance value, dermal for a Category 2 classification (2000 mg/kg bw ≥ C > 1000 mg/kg bw). No classification required.