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Diss Factsheets

Administrative data

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 in the following, but no key values were defined for 4 -Nitrophenol. 
In the technical report of the National Toxicology Program (NTP) No. 417 of 1993, and in the BUA report of 1993, carcinogenesis studies of p-Ntrophenol have been reviewed which are summarized under "discussion" below.

Key value for chemical safety assessment

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), no classification with respect to carcinogenicity is required for PNF.

Additional information

In the NTP report the following information on carcinogenicity studies using 4 -nitrophenol is provided:

Groups of 60 Swiss-Webster mice of each sex received p-Nitrophenol in acetone applied to the interscapular skin. Doses of 0, 40, 80 or 160 mg/kg p-nitrophenol were administered to mice 3 days per week over 78 weeks.

Mice were examined daily for mortality, changes in appearance or behaviour and signs of toxicologic or pharmacologic effects. Clinical effects were recorded weekly during the first 13 weeks and then at a 4 -week interval until the end of the study.Bodyweights were recorded weekly during the first 12 weeks and then at a 4 -week interval until the end of the study. Complete necropsies and histopathologic examination were performed on all mice.

At the end of the study, the survival of dosed females (all groups) and males receiving 80 or 160 mg/kg was similar to that of controls. Survival of males treated at 40 mg/kg was significantly lower than that of controls, but the difference was not considered to be related to treatment. Survival rates of mice receiving 0, 40, 80 or 160 mg/kg p-Nitrophenol were 29/60, 17/60, 26/60, and 24/60 for males and 35/60, 26/60, 33/60 and 27/60 for females. Deaths after 60 weeks were caused by generalised amyloidosis and secondary kidney failure. The severity of amyloidosis was similar among dosed and control animals. At the end of the study,the final mean bodyweights of the dosed groups of each sex were similar to those of the controls. No biologically significant lesions were observed that were related to the dermal administration of p-Nitrophenol.

Under the conditions of the 18 month dermal studies, there was no evidence of carcinogenic activity in male or female mice receiving 40, 80 or 160 mg/kg p-nitrophenol.

In the BUA report, in addition to the studies described above, a long-term study in Syrian hamsters is cited. Animals were administered single weekly dosages of 10 or 5 mg of an emission sample, dissolved in distilled water. After treatment for 18 weeks, the hamsters were kept until, 98% had ied (117 weeks in the case of males and 103 weeks in the case of females). No significant increase in the incidence of tumours was found upon histopathological examination. Since the emission sample contained a ixture of substance, the dose level of 4 -nitrophenol was low at 0.018 mg in the 10 mg sample.

Overall, no carcinogenic effects were seen in rats and hamsters treated at 4 -nitrophenol.