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Administrative data

Description of key information

ORAL
Key study:- Liwska and Watson (2012) 'CN-3384A Twenty-eight day repeated dose oral (gavage) toxicity study in the rat' conducted in line with standardised guidelines. The NOAEL was determined to be 1000 mg/kg bw/day.
INHALATION
A repeat-dose 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
A repeat-dose dermal study is only required if (i) skin contact is likely with the use of the substance and (ii) the physico-chemical and toxicological properties of the substance suggest the potential for a significant rate of absorption through the skin. Dermal exposure from the use of the substance is considered to be unlikely and there is no data to suggest that the substance is absorbed through the skin a at significant rate. A data waiver has been submitted to address this endpoint.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat

Additional information

Oral

The key study was performed in compliance with GLP and to standardised guidelines OECD 407, EU Method B.7., EPA OPPTS 870.3050 and Japanese guidelines with a sufficient level of detail to assess the quality of the study. The study was performed to a good standard and was assigned a reliability score of 1, using the criteria for assessing data quality as set out in Klimisch (1997).

Inhalation

Inhalation exposure to the substance is not considered likely.

Dermal

Dermal exposure to the substance is not considered likely.

Justification for classification or non-classification

The data do not indicate that any classification for repeat-dose toxicity is required.

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