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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Kerocom FM 38 was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg body weight/day (mg/kg bw/d; test group 0, drinking water served as vehicle), 100 mg/kg bw/d (test group 1), 300 mg/kg bw/d (test group 2) and 1000 mg/kg bw/d (test group 3) according to OECD 421 and GLP (BASF, 2013). The objective of the study was to detect possible effects of the test substance on the integrity and performance of male and female reproductive systems including gonadal function, mating behavior, conception, gestation and parturition. Furthermore, it was intended to obtain information about the general toxicological profile including target organs and the no observed adverse effect level (NOAEL) after repeated oral administration. The duration of treatment covered a 2-week pre-mating and mating period in both sexes, at least 3 days post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

The parents' and the pups' state of health was checked each day, and parental animals were examined for their mating and reproductive performances. After 2 weeks of premating treatment, the F0 animals were mated to produce F1 generation pups. Mating pairs were from the same test group. Mating was discontinued as soon as sperm was detected in the vaginal smear. F0 animals were examined for their reproductive performance including determination of the number of implantation sites and the calculation of postimplantation loss for all F0 females. No treatment-induced changes were monitored with respect to fertility and mating indices. Food consumption as well as body weight gain were similar in the treatement groups as compared to control animals. Moreover, no treatment-related changes in biochemistry, organ weights and histopathology were noted in parental animals. For the F1 pups, no treatment-related adverse effects were observed; viability, sex ratios, pup weights, pup number and gross necroscopy were not affected by treatment up to the highest concentration.

Taken together, under the conditions of this reproduction/developmental toxicity screening test the no observed adverse effect level (NOAEL) for reproductive performance and fertility in male and female Wistar rats was 1000 mg/kg bw/d. The NOAEL for general, systemic toxicity of the test substance was also 1000 mg/kg bw/d for the F0 parental animals. The NOAEL for developmental toxicity was 1000 mg/kg bw/d.


Short description of key information:
NOAEL = 1000 mg/kg/d (highest dose tested; OECD 421, BASF SE, 2013)

Effects on developmental toxicity

Description of key information
NOAEL = 1000 mg/kg/d (highest dose tested; OECD 421, BASF SE, 2013)
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
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

Kerocom FM 38 was administered orally by gavage to groups of 10 male and 10 female Wistar rats (F0 animals) at dose levels of 0 mg/kg body weight/day (mg/kg bw/d; test group 0, drinking water served as vehicle), 100 mg/kg bw/d (test group 1), 300 mg/kg bw/d (test group 2) and 1000 mg/kg bw/d (test group 3) according to OECD 421 and GLP (BASF, 2013). The objective of the study was to detect possible effects of the test substance on the integrity and performance of male and female reproductive systems including gonadal function, mating behavior, conception, gestation and parturition. Furthermore, it was intended to obtain information about the general toxicological profile including target organs and the no observed adverse effect level (NOAEL) after repeated oral administration. The duration of treatment covered a 2-week pre-mating and mating period in both sexes, at least 3 days post-mating in males, and the entire gestation period as well as 4 days of lactation and two weeks thereafter in females.

The parents' and the pups' state of health was checked each day, and parental animals were examined for their mating and reproductive performances. After 2 weeks of premating treatment, the F0 animals were mated to produce F1 generation pups. Mating pairs were from the same test group. Mating was discontinued as soon as sperm was detected in the vaginal smear. F0 animals were examined for their reproductive performance including determination of the number of implantation sites and the calculation of postimplantation loss for all F0 females. No treatment-induced changes were monitored with respect to fertility and mating indices. Food consumption as well as body weight gain were similar in the treatement groups as compared to control animals. Moreover, no treatment-related changes in biochemistry, organ weights and histopathology were noted in parental animals. For the F1 pups, no treatment-related adverse effects were observed; viability, sex ratios, pup weights, pup number and gross necroscopy were not affected by treatment up to the highest concentration.

Taken together, under the conditions of this reproduction/developmental toxicity screening test the no observed adverse effect level (NOAEL) for reproductive performance and fertility in male and female Wistar rats was 1000 mg/kg bw/d. The NOAEL for general, systemic toxicity of the test substance was also 1000 mg/kg bw/d for the F0 parental animals. The NOAEL for developmental toxicity was 1000 mg/kg bw/d.

Justification for classification or non-classification

Based on the available data, the test substance is not classified with regard to toxicity to reproduction according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.

Additional information