on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. 8.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Ministry in accordance with Articles 36 or 37 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met: serious or severe toxicity effects of — particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or effects shown in substances with a clear — relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or the substance may have a dangerous — property that cannot be detected in a 90-day study. 8.6.4. Further studies shall be proposed by the registrant or may be required by the Ministry in accordance with Articles 36 or 37 in case of: toxicity of particular concern (e.g. — serious/severe effects), or indications of an effect for which the — available evidence is inadequate for toxicological evaluation and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or particular concern regarding exposure (e.g. — use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed). 8.7. Reproductive toxicity 8.7. The studies need not be conducted if: the substance is known to be a genotoxic — carcinogen and appropriate risk management measures are implemented, or
on the basis of all available data, including toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity can be made, additional investigations shall be considered. 8.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Ministry in accordance with Articles 36 or 37 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met: — serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or — effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or — the substance may have a dangerous property that cannot be detected in a 90-day study. 8.7. Reproductive toxicity 8.6.4. Further studies shall be proposed by the registrant or may be required by the Ministry in accordance with Articles 36 or 37 in case of: — toxicity of particular concern (e.g. serious/severe effects), or — indications of an effect for which the available evidence is inadequate for toxicological evaluation and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxicological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity), or — particular concern regarding exposure (e.g. use in consumer products leading to exposure levels which are close to the dose levels at which toxicity is observed). 8.7. The studies need not be conducted if: — the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or