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Key value for chemical safety assessment

Effects on fertility

Additional information

One screening study is available for the assessment of reproductive parameters. This study was performed according to OECD 422 under GLP (BASF, 2013). Here, four groups of ten Wistar Han rats (male/female) were exposed by oral gavage to Hydroxyacetophenone with 0, 40, 150 and 600 mg/kg. Males were exposed for 30 days (prior to mating, during mating, and up to termination) and females were exposed for 43-46 days (2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation). No treatment-related mortality and no clinical signs of toxicity were noted during the study period. Occurring salivation was probably related to the taste of Hydroxyacetophenone. Body weights resulted in no treatment-related effects. Changes in haematological parameters were mostly not dose-dependent and were considered to be of no toxicological relevance. Changes in clinical biochemistry were only minimally outside the range, were not dose-related and occurred in the absence of treatment-related histopathological changes. The assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired spermatogenesis after test item treatment. No abnormalities were seen in the reproductive organs of the animals that failed to deliver healthy offspring. Mating, fertility and conception indices, precoital time, and number of corpora lutea and implantation sites were unaffected by treatment.The statistically significantly shorter duration of gestation at 40 mg/kg was slight in nature. No signs of difficult or prolonged parturition were noted among the remaining pregnant females. A total of three females, one each at 40, 150 and 600 mg/kg, did not deliver live offspring and were found to be non-pregnant. The incidences of non-pregnancy did not show a dose-related trend and were within the expected range. Therefore, these differences were considered not to be of toxicological relevance.One female at 600 mg/kg did not deliver. Two dead foetuses in the left uterus horn were observed at necropsy. Findings among the two pups consisted of missing hindlegs, right foot and/or tail apex (probably due to cannibalism), and absence of milk in the stomach. All other litters of the same group comprised live offspring and were of normal size, this incidental occurrence was considered to be of no toxicological relevance. Examination of cage debris of pregnant females revealed no signs of abortion or premature birth. In the pubs, no toxicologically relevant changes or clinical signs in body weights were noted. Incidental macroscopic findings of pups consisted of a wound on the abdomen and left hindleg, small appearance and absence of milk in the stomach. The nature and incidence of these findings remained within the range considered normal for pups of this age. No deficiencies in maternal care were observed.

Effects on developmental toxicity

Additional information

The available OECD 422 guideline study gave no hint on any developmental toxicity or teratogenicity.

Justification for classification or non-classification

Based on the available data, classification is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.