Registration Dossier

Administrative data

Description of key information

- Acute toxicity:
Oral: LD50: >2000 mg/kg in the rat
Inhalation (4 hours) LD50: > 2600 mg / m3 in the rat
Dermal: LD50: > 2000 mg/kg in the rabbit

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
A number of studies are available on three structural analogues of the registered substance, all demonstrating the LD50 to be in excess of 2000 mg/kg body weight.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
2 600 mg/m³
Quality of whole database:
A single reliable study is available on a structural analogue of the registered substance, this demonstrating the LD50 to be in excess of the maximum concentration technically possible to achieve in the atmosphere..

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Studies are available on two structural analogues of the registered substance, all demonstrating the LD50 to be in excess of 2000 mg/kg body weight.

Additional information

Data are available from a number of studies on up to three structural analogues of the registered substance. A number of these are older studies and the details available are not adequate to permit robust evaluation of the reported findings.

 

It is noted that, when assessing acute toxicity by the inhalation route, the limit concentrations for gases, vapours, and aerosols are 20000 ppm, 20 mg/L, and 5 mg/L, respectively (or the maximum attainable concentration). It is recognized that it is technically challenging to generate limit concentrations as aerosols and, with most substances, a concentration of 2 mg/L (2000 mg/m3) is the approximate limit at which a respirable particle size can be achieved.

Justification for classification or non-classification

Classification with regard to acute oral and dermal toxicity is not justified based on the observed lack of mortality at a dose level of 2000 mg/kg.

Classification with regard to acute (4 hour) inhalation toxicity is not justified based on the observed lack of mortality at an exposure level of 2600 mg / m3, regarded as being the highest achievable exposure concentration.

Classification according to the criteria of Regulation 1272/2008/EC (CLP) and Directive 67/548/EEC (DSD) is therefore not indicated.