Registration Dossier

Administrative data

Description of key information

ORAL
Key study:- Sanders (2011a) 'CN-3384A: Acute oral toxicity in the rat - fixed dose method' conducted in line with OECD Guideline 420 and EU Method B1bis. The 14 day LD50 was determined to be >2000 mg/kg bw.
INHALATION
An acute inhalation study does not need to be performed as the substance has very low vapour pressure and high melting point, so the potential for the generation of inhalable forms is low and the use of the substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. A data waiver has been submitted to address this endpoint.
DERMAL
Key study:- Sanders (2011b) 'CN-3384A: Acute dermal toxicity (limit test) in the rat' conducted in line with OECD Guideline 402 and EU Method B3. The 14 day LD50 was determined to be >2000 mg/kg bw.

Key value for chemical safety assessment

Additional information

Oral

The key study was performed in compliance with GLP and to OECD Guideline 420 and EU Method B.1bis with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).

Dermal

The key study was performed in compliance with GLP and to OECD Guideline 402 and EU Method B.3 with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard in line with an accepted, standardised guideline and was assigned a reliability score of 1 using the criteria for assessing data quality as set out in Klimisch (1997).

Justification for classification or non-classification

The data do not indicate that any classification for acute toxicity is required.