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Key value for chemical safety assessment

Effects on fertility

Description of key information
None
Effect on fertility: via oral route
Dose descriptor:
NOAEL
1 000 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 Orange F08 -0314 following repeated daily administration by oral gavage to Wistar rats. The reproductive/developmental toxicity screening test provided initial information on possible effects on male and female reproductive performance such as gonadal function, mating behaviour, conception, pregnancy, parturition and also on the development of the F1 offspring from conception to Day 4 post-partum.

The mating indices were 100% in all groups. The fertility indices were 100% in the Control group and 92% in the test item treated groups, due to 1/12 non-pregnant females in each group, values which are comparable with concurrent control data in Wistar rats.  Gestation index was 100% in all groups. The sex ratios were slightly lower than control in all treated groups, attaining statistical significance both on post natal day (PND) 0 and PND4 in the 1000 mg/kg bw/day High dose group (40.79, p<0.01 in the High dose Main group, versus 61.22 in the Control group on PND0, and 39.44, p<0.01, versus 61.27 on PND4, respectively). Although a test item related effect cannot be excluded, this variation was considered due to an incidentally higher number of female foetuses in the Control group and individual lower number in the High dose group.

In conclusion, the no observed adverse effect level (NOAEL) for Reactive Orange F08-0314 for parental and F1 effects is considered to be 1000 mg/kg bw/day.


Short description of key information:
Summary of data on effects of reproductive toxicity

Effects on developmental toxicity

Description of key information
Summary of data on reproductive toxicity
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

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

Justification for classification or non-classification

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.

Additional information