Registration Dossier
Registration Dossier
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EC number: 231-765-0 | CAS number: 7722-84-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
Studies on the reproductive toxicity of hydrogen peroxide employing appropriate study methods are not available. An appropriate 90-day drinking water study with catalase deficient mice (Freeman 1997) and carcinogenicity studies with catalase deficient mice (Ito et al. 1981 a, b) and F344 rats (Takajama 1980) did not identify testes and ovaries as target organs for toxicology. Foetotoxic effects were reported from a developmental toxicity study in Wistar rats (Morijama 1982). Nevertheless the reliability of this study is questionable due to several uncertainties concerning the exposure and the effect mechanisms of hydrogen peroxide and the study cannot be used for an evaluation.
It has been shown that hydrogen peroxide is rapidly metabolised in the body to oxygen and water and does not bio-accumulate. In none of the repeated dose studies described in the dossier, hydrogen peroxide causes directly systemic effects. It is also doubtful whether hydrogen peroxide would reach inner organs as ovaries and testes as well as foetuses to cause reproductive and/or developmental toxicity. It is concluded that reproductive and developmental toxicity studies will not provide any additional useful information for the risk assessment of hydrogen peroxide and should therefore not be conducted due to animal welfare reasons.
Short description of key information:
There are no reproductive toxicity studies available employing appropriate study methods. A reliable 90-day drinking water study with catalase deficient mice (Freeman, 1997) and carginogenicity studies with catalase deficient mice (Ito, 1981 a; b) and F344 rats (Takajama, 1980) did not identify testes and ovaries as target organs for toxicology. Foetotoxic effects were reported from a developmental toxicity study in Wistar rats (Morijama, 1982). Nevertheless the reliability of this study is questionable due to several uncertainties concerning the exposure and the effect mechanisms of hydrogen peroxide and cannot be used for an evaluation.
Effects on developmental toxicity
Description of key information
There are no reproductive toxicity studies available employing appropriate study methods. A reliable 90-day drinking water study with catalase deficient mice (Freeman, 1997) and carginogenicity studies with catalase deficient mice (Ito, 1981 a; b) and F344 rats (Takajama, 1980) did not identify testes and ovaries as target organs for toxicology. Foetotoxic effects were reported from a developmental toxicity study in Wistar rats (Morijama, 1982). Nevertheless the reliability of this study is questionable due to several uncertainties concerning the exposure and the effect mechanisms of hydrogen peroxide and cannot be used for an evaluation.
Additional information
Studies on the reproductive toxicity of hydrogen peroxide employing appropriate study methods are not available. An appropriate 90-day drinking water study with catalase deficient mice (Freeman 1997) and carcinogenicity studies with catalase deficient mice (Ito et al. 1981 a, b) and F344 rats (Takajama 1980) did not identify testes and ovaries as target organs for toxicology. Foetotoxic effects were reported from a developmental toxicity study in Wistar rats (Morijama 1982). Nevertheless the reliability of this study is questionable due to several uncertainties concerning the exposure and the effect mechanisms of hydrogen peroxide and the study cannot be used for an evaluation.
It has been shown that hydrogen peroxide is rapidly metabolised in the body to oxygen and water and does not bio-accumulate. In none of the repeated dose studies described in the dossier, hydrogen peroxide causes directly systemic effects. It is also doubtful whether hydrogen peroxide would reach inner organs as ovaries and testes as well as foetuses to cause reproductive and/or developmental toxicity. It is concluded that reproductive and developmental toxicity studies will not provide any additional useful information for the risk assessment of hydrogen peroxide and should therefore not be conducted due to animal welfare reasons.
Justification for classification or non-classification
It has been shown that hydrogen peroxide is rapidly metabolised in the body to oxygen and water and does not bio-accumulate. In none of the repeated dose studies described in the dossier, hydrogen peroxide causes directly systemic effects. It is also doubtful whether hydrogen peroxide would reach inner organs as ovaries and testes as well as foetuses to cause reproductive and/or developmental toxicity. It is concluded that reproductive and developmental toxicity studies will not provide any additional useful information for the risk assessment of hydrogen peroxide and should therefore not be conducted due to animal welfare reasons.
Additional information
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