Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Only one study available.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The performed screening test shows no adverse effects up to 200 mg/kg bw/day, a NOAEL of 150 mg/kg bw/day for repeated dose toxicity is available.

The results of the screening test are of limited use for the characterisation of this hazard as stated in the OECD Guideline:

"This test does not provide complete information on all aspects of reproduction and

development. In particular, it offers only limited means of detecting post-natal manifestations of prenatal

exposure, or effects that may be induced during post-natal exposure."

For the risk characterisation it is possible to use the test results, if the exposure is clearly below the NOAEL.


Short description of key information:
In a Screening Test for toxicity to reproduction and development, perforemed according to Guideline 421, doses of 12.5, 50 and 200 mg/kg bw/day were tested. No adverse effect on the reproduction or development was observed.

Justification for selection of Effect on fertility via oral route:
Well performed study according to OECD Guidelines

Effects on developmental toxicity

Description of key information
In a Screening Test for toxicity to reproduction and development, perforemed according to Guideline 421,
Doses of 12.5, 50 and 200 mg/kg bw/day were tested.
No adverse effect on the reproduction or development was observed.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
only one study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The performed screening test shows no adverse effects up to 200 mg/kg bw/day, a NOAEL of 150 mg/kg bw/day for repeated dose toxicity is available.

The results of the screening test are of limited use for the characterisation of this hazard as stated in the OECD Guideline:

"This test does not provide complete information on all aspects of reproduction and

development. In particular, it offers only limited means of detecting post-natal manifestations of prenatal

exposure, or effects that may be induced during post-natal exposure."

For the risk characterisation it is possible to use the test results, if the exposure is clearly below the NOAEL.


Justification for selection of Effect on developmental toxicity: via oral route:
well performed study according to OECD Guidelines

Justification for classification or non-classification