Registration Dossier

Administrative data

Description of key information

Three studies are available for the acute oral toxicity endpoint:
Clauzeau. J (1993) - LD50 (rat): >2000 mg/kg bw
Paster. Z (1978a) - LD50 (rat): 4260 mg/kg bw
Paster. Z (1978b) - LD50 (rabbit): 540 mg/kg bw
Three studies are available for the acute inhalation toxicity endpoint:
Schorsch. F (1997) - 4h-LC50 (rat): 35000 mg/m^3
Moon. Y.H. et al (1998) - 4h-LC50 (rat): 14374 ppm
Labbé. R (1997a) - 6h-LC50 (rat): between 25 and 35 mg/L
Two studies are available for the acute dermal toxicity endpoint:
de Jouffrey. S (1995a) - LD50 (rat): >2000 mg/kg bw
Paster. Z (1979) - LD50 (rabbit): >10 mL/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
35 000 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Key values have been selected from suitable available studies (i.e. use of recognised species for a given endpoint, recognised exposure time), together with a worst case approach.

Key studies for inhalation have been selected for both systemic toxicity and local effects. The systemic toxicity via inhalation value is taken from the Moon et al (1998) study in which effects seen at the lowest treatment group (10909ppm) consisted of slow reactions and ataxia observed in some animals. These results were considered to represent a NOAEC value as no mortality or other signs of systemic toxicity were observed at this concentration.

The local effects via inhalation NOAEC value is taken from the Schorsch (1997) study in which inflammation of the lung parenchyma which was characterised by pulmonary emphysema and oedema was observed in all test groups, and caused mortalities in test groups above 30.2g/m3. The lowest test group (30.2g/m3) was therefore identified as the NOAEC concentration as local effects did not cause mortalities.

Justification for classification or non-classification

Based upon the high LD50 and LC50 values for oral, dermal and inhalation exposure, and the absence of other major significant effects, the test substance does not need to be classified for acute toxicity according to Directive 67/548/EEC or Regulation (EC) No 1272/2008.