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Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

In a GLP compliant reproduction/developmental toxicity study conducted in accordance with standardised guideline OECD 421, the reproductive/developmental toxicity of the test substance was determined in a screening study.

The test substance was administered orally to three groups of ten male and ten female rats for up to eight weeks at 100, 300 or 1000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone. Clinical signs, body weight changes, dietary intake and water consumption were assessed. Pairing of animals within each dose group was undertaken on a one male to one female basis on day 15. Females were subsequently allowed to litter and rear their offspring to day 5 of lactation. During the lactation phase, daily clinical observations were performed on all surviving offspring. Litter size, individual offspring body weights and assessment of offspring surface righting reflex were recorded. Adult males were terminated on day 43 followed by the termination of all pregnant females and surviving offspring on day 5 post partum or on day 26 post coitum for non-pregnant females. All animals were subject to a gross necropsy examination and histopathological evaluation of reproductive tissues was performed.

There were no unscheduled deaths or clinical signs of toxicity in parents and offspring. There were no toxicologically significant effects on body weights or adverse effects on food and water consumption. There were no treatment-related effects noted during mating or on conception rates and gestation lengths. Litter size at birth, offspring body weight gain and litter weights at birth and subsequently on days 1 and 4 post partum were comparable to controls. No toxicologically significant macroscopic abnormalities, treatment-related effects on body weights and treatment-related microscopic findings were detected.

The oral administration of the test substance to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any treatment-related reproductive/developmental effects. The NOEL for the test substance was determined to be 1000 mg/kg/day.


Short description of key information:
Key study:- Dunster and Watson (2012) 'CN-3384A Oral (gavage) reproduction/developmental toxicity screening test in the rat (OECD 421)' conducted in line with standardised guidelines. The NOEL was determined to be 1000 mg/kg/day.

Effects on developmental toxicity

Description of key information
ORAL
Key study:- Dunster and Watson (2012) 'CN-3384A Oral (gavage) reproduction/developmental toxicity screening test in the rat (OECD 421)' conducted in line with standardised guidelines. The NOEL was determined to be 1000 mg/kg/day.
Additional information

In a GLP compliant reproduction/developmental toxicity study conducted in accordance with standardised guideline OECD 421, the reproductive/developmental toxicity of the test substance was determined in a screening study.

The test substance was administered orally to three groups of ten male and ten female rats for up to eight weeks at 100, 300 or 1000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone. Clinical signs, body weight changes, dietary intake and water consumption were assessed. Pairing of animals within each dose group was undertaken on a one male to one female basis on day 15. Females were subsequently allowed to litter and rear their offspring to day 5 of lactation. During the lactation phase, daily clinical observations were performed on all surviving offspring. Litter size, individual offspring body weights and assessment of offspring surface righting reflex were recorded. Adult males were terminated on day 43 followed by the termination of all pregnant females and surviving offspring on day 5post partumor on day 26post coitumfor non-pregnant females. All animals were subject to a gross necropsy examination and histopathological evaluation of reproductive tissues was performed.

There were no unscheduled deaths or clinical signs of toxicity in parents and offspring. There were no toxicologically significant effects on body weights or adverse effects on food and water consumption. There were no treatment-related effects noted during mating or on conception rates and gestation lengths. Litter size at birth, offspring body weight gain and litter weights at birth and subsequently on days 1 and 4 post partum were comparable to controls. No toxicologically significant macroscopic abnormalities, treatment-related effects on body weights and treatment-related microscopic findings were detected.

The oral administration of the test substance to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any treatment-related reproductive/developmental effects. The NOEL for the test substance was determined to be 1000 mg/kg/day.

Justification for classification or non-classification

The data did not indicate that any classification for toxicity to reproduction or developmental toxicity is required.