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Effects on fertility

Description of key information
None
Effect on fertility: via oral route
Dose descriptor:
NOAEL
250 mg/kg bw/day
Additional information

A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was conducted to obtain information on the possible toxic effects of REACTIVE RED F08-0146 following repeated daily administration by oral gavage to Wistar rats.

 

REACTIVE RED F08-0146 administered to parental generation under the conditions of this study did not lead to any adverse effects considered related to treatment or toxicologically significant in the F1 generation at up to and including 250 mg/kg bw/day dose level. At 1000 mg/kg bw/day, the intrauterine mortality, post-natal mortality and subsequently the total mortality were statistically higher than control (28.06% vs. 9.73%, 8.12% vs. 0.61% and 32.7% vs. 10.3% in the High dose vs. the control groups), effects considered possibly related to REACTIVE RED F08-0146 administration at the High dose level.

 

There were no REACTIVE RED F08-0146 adverse effects on the reproductive ability or in the mating or gestation indices. In all groups, the mating indices were 100%, the fertility indices, 92% due to 1/12 non-pregnant females in each group, and the gestation indices, 100%, values within the physiological ranges for Wistar rats. Successful coitus (sperm positive vaginal smears and/or vaginal plugs) generally occurred within up to 5 days of pairing (cohabitation). No test item effect on the duration of pregnancy or abnormalities in the gestation outcome ascribed to the treatment were observed. The mean duration of pregnancy was similar in the control and test item treated groups. There was no evidence of Reactive Red F08-0146-related macroscopic or microscopic findings in the High Dose animals in the reproductive organs. The number of corpora lutea and implantation sites were comparable in the treated groups up to and including 1000 mg/kg bw/day with the mean value recorded in the Control group.

 

For reproductive toxicity, the no observed effect level (NOEL) for parental/adult effects is considered to be 1000 mg/kg bw/day for the males and 250 mg/kg bw/day for the females, due to the higher intrauterine, postnatal and total foetal mortality at 1000 mg/kg bw/day, correlated with a NOEL of 250 mg/kg bw/day for F1 offspring, based on a possible REACTIVE RED F08-0146-related effect on pups survival at 1000 mg/kg bw/day.  


Short description of key information:
Summary of data on effects of fertility

Effects on developmental toxicity

Description of key information
Summary of data on developmental toxicity
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
250 mg/kg bw/day
Additional information

See above for summary of results of the combined repeated dose toxicity and reproductive/developmental toxicity screening test.

Toxicity to reproduction: other studies

Additional information

The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for reproductive toxicity is therefore required.

Justification for classification or non-classification

Additional information

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