Registration Dossier

Administrative data

Description of key information

Oral, ALD50, male rat 5000 mg/kg bw (DuPont Haskell, Waritz 1966) 
Inhalation, LC50 vapour, male rat 40 mg/L (DuPont Haskell, Kwon 1966)
Dermal, ALD50, rabbit >3400 mg/kg bw (DuPont Haskell, Majkut 1966)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
40 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 400 mg/kg bw

Additional information

Oral:

Only a single oral toxicity (ALD50) study, without GLP and not following any guideline (dating from 1966), is available. The study is considered to be relevant and reliable (Klimisch 2). Although only single animals were tested (8 doses with 1 male each), the result (5000 mg/kg bw) is far above the present-day limit test dose (2000 mg/kg bw). It is therefore considered adequate for the purposes of risk assessment, classification and labelling.

Dermal:

Only a single combined skin irritation /dermal toxicity study in rabbits, without GLP and not following any guideline (dating from 1966), is available. The study is considered to be relevant and reliable (Klimisch 2). Although only single animals were tested (3 doses), the complete absence of clinical signs up to the highest dose (3400 mg/kg bw, 6 hour exposure) indicates a result far above the present-day limit test dose (2000 mg/kg bw). It is therefore considered adequate for the purposes of risk assessment, classification and labelling.

Inhalation:

Only a single whole-body vapour inhalation toxicity study in male rats, without GLP and not following any guideline (dating from 1966), is available. The study is considered to be relevant and reliable (Klimisch 2). Six animals per dose were tested (5 doses) and the LC50 value was statisically calculated to be 40 mg/L, far above the present-day limit test concentration for vapours (20 mg/L). The result is therefore considered adequate for the purposes of risk assessment, classification and labelling.

Justification for classification or non-classification

The reported data for actute oral, dermal and inhalation toxicity are all above the current EU limits for acute toxicity classification.

  • Oral, ALD50, male rat 5000 mg/kg bw (DuPont Haskell, Waritz 1966)
  • Inhalation, LC50 vapour, male rat 40 mg/L (DuPont Haskell, Kwon 1966)
  • Dermal, ALD50, rabbit >3400 mg/kg bw (DuPont Haskell, Majkut 1966)