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Key value for chemical safety assessment

Effects on fertility

Description of key information
During 28-day-treatment of male and female Wistar rats  with 0, 4, 20 or 100 mg/kg bw/d  1,2 -dichloro-4 -nitrobenzene  dissolved in sesame oil according to OECD TG 407 reproductive organs were not affected (Hoechst AG 1993).
Effect on fertility: via oral route
Dose descriptor:
NOAEL
100 mg/kg bw/day
Additional information

As confirmed by literature (e.g. Mangelsdorf I. et al (2003) Regul. Toxicol. Pharmacol. 37, 356 -369) histopathologogical examinations in repeated dose toxicity studies are of high value and of high sensitivity for the evaluation of reproductive toxicity. Also, it is agreed that histopathological changes on the reproductive organs in repeated dose toxicity studies are indicative of effects on fertility. In the above cited study no effects were observed in the reproductive organs up to the highest used dose of 100 mg/kg bw/day although clear systemic toxicity is given.Therefore no further testing should be required.


Short description of key information:
Studies dealing specifically with toxicity to reproduction were not identified.
During 28-day-treatment of male and female Wistar rats with 0, 4, 20 or 100 mg/kg bw/d 1,2 -dichloro-4 -nitrobenzene dissolved in sesame oil according to OECD TG 407 reproductive organs were not affected despite clear systemic toxicity up to the maximum tolerated dose of 100 mg/kg bw/day (Hoechst AG 1993 cited in UNEP 2005, see also toxicity to reproduction: other studies). Therefore there is no evidence of toxicity to the reproductive organs.

Effects on developmental toxicity

Description of key information
Pregnant female Sprague-Dawley rats were orally applied with 0, 10, 30, or 100 mg/kg bw/day 1,2 -dichloro-4-nitrobenzene dissolved in corn oil by gavage resulting in developmental effects (significant iincrease in dilated ureters) in the presence of maternal toxicity (significantly reduced body weight gain on gd 6 -10). The NOAEL for maternal toxicity and developmental toxicity is 10 mg/kg bw/d (Monsanto 1987)
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
10 mg/kg bw/day
Additional information

Pregnant female Sprague-Dawley rats were orally applied with 0, 10, 30, or 100 mg/kg bw/day 1,2 -dichloro-4-nitrobenzene dissolved in corn oil by gavage resulting in developmental effects (significant iincrease in dilated ureters) in the presence of maternal toxicity (significantly reduced body weight gain on gd 6 -10). The NOAEL for maternal toxicity and developmental toxicity is 10 mg/kg bw/d (Monsanto 1987)

Toxicity to reproduction: other studies

Additional information

During 28-day-treatment of male and female Wistar rats with 0, 4, 20 or 100 mg/kg bw/d 1,2 -dichloro-4 -nitrobenzene dissolved in sesame oil according to OECD TG 407 reproductive organs were not affected (Hoechst AG 1993).

Justification for classification or non-classification

Fertility

Due to the above discussion no classification with respect to fertility assessment has to be included.

Developmental toxicity

The available developmental toxicity study shows that developmental toxic effects occur only in the presence of maternal toxicity. Thus, there is no need for classification with respect to developmental toxicity.