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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information
In the CICAD document on 4 -Nitrophenol (IPCS CICAD 2000), and in the BUA report of 1992,information on reproductive and developmental toxicity 
has been reviewed and is summarized in the following.

In a valid two-generation study with groups of 24 female and 12 male Sprague-Dawley rats carried out by Angerhofer (1985), 4-nitrophenol dissolved 
in ethanol was applied dermally at doses of 0, 50, 100, or 250 mg/kg body weight per day, 5 days/week. The F0generation was exposed over a 
period of 140 days before mating. Dosing of the F0females continued throughout breeding, gestation, and lactation. Groups of 26 females and 
13 males of the F1generation were then exposed for 168 days in the same manner as had been the F0rats; the females were again exposed 
throughout breeding, gestation, and lactation. Apart from dose-related signs of skin irritation (erythema, scaling, scabbing, and cracking) in 
dosed animals, the gross and histopathological examinations provided no indication of significant adverse effects. The calculated indices 
concerning fertility, gestation, viability, and lactation were not different from those of controls. The testis to body weight ratios in the F0generation 
were not affected, and histological lesions were not observed in the testes.  
In a study performed by Booth et al. (1983), groups of 50 female CD-1 mice received daily oral doses of 400 mg 4-nitrophenol/kg body weight via 
gavage from day 7 to day 14 of gestation. The survival rate in pregnant mice (n= 36) was 81% versus 100% in controls, and dosed animals showed 
less maternal weight gain. No changes were observed in the reproductive index (ratio between survivors delivered and pregnant survivors). 
The average number of live pups per litter was slightly decreased, but 4-nitrophenol produced no gross abnormalities.  Kavlock (1990) studied the 
developmental toxicity of 4-nitrophenol in Sprague-Dawley rats. The substance (dissolved in a mixture of water, Tween 20, propylene glycol, and 
ethanol [4:4:1:1]) was applied via gavage to groups of 12-13 animals at doses of 0, 100, 333, 667, or 1000 mg/kg body weight on day 11 of gestation. 
Endpoints concerning maternal toxicity included signs of toxicity, mortality, body weight gain, and the number of implantation scars in the uteri at 
weaning. In the offspring, viability, body weight on postnatal days 1-6, overt malformations, and perinatal loss were recorded. In dams, the mortality 
was increased at a dose level of>667 mg/kg body weight; at a dose level of>333 mg/kg body weight, the litter size on postnatal days 1 and 6 was 
non-significantly decreased.

Short description of key information:
According to regulation (EC) 1907/2006 of the European parliament and the council of 18 December 2006 (Article 18),
data on reproductive toxicity on transported isolated intermediates needs to be described, if data on this endpoint are available,
but no chemical safety assessment is necessary. Therefore, publicly available data on reproductive toxicity of 4 -Nitrophenol is
summarized under "discussion", but no key values were defined for 4 -Nitrophenol.

Justification for classification or non-classification

Based on the results reviewed in the reports and taking into account the provisions laid down in Council Directive 67/548/EEC and CLP (1272/2008/EC), PNF does not need to be classified as toxic to reproduction.

Additional information