Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-804-9 | CAS number: 99-96-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Carcinogenicity
Administrative data
Description of key information
A 96 weeks feeding study with Wistar rats was performed with dosages of 0%, 2%, 8% Methyl-4-hydroxy benzoate (methylparaben) in the diet. Please refer to the detailed justification of the read across approach in the separate read across rationale annexed to the Chemical Safety Report (in section 13 of IUCLID). In treatments with 8% drug diet reduced body weight gain was observed. Gross pathology and histopathology revealed no abnormal findings. Mongrel dogs were dosed with Methy-4-hydroxy benzoate in gelatine capsules. The highest dose group received 1000 mg/kg bw per day for 6 days a week for at least 378 days. Clinical observations, body weights, haematology, urine analysis, gross pathology and histopathology revealed no abnormalities. As the studies with repeated administration revealed toxicity at lower dose levels, these levels are also taken for evaluation of carcinogenicity.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Justification for classification or non-classification
Two longterm studies one with rats another one with dogs revealed no hints for a carcinogenic patential of 4 -HBA.
Additional information
Data of methylparaben and ethylparaben can be taken for the evaluation of 4-HBA as there is a close structural similarity and the fact that 4-HBA is the main breakdown product of the precursor methylparaben and ethylparaben after oral administration. Justification for read-across: similar chemical structure (common functional group) and common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals (for justification see annex with read across rationale to the Chemical Safety Report (in section 13 of IUCLID)).
A 96 weeks feeding study with the read across substance Methy-4-hydroxy benzoate (methylparaben) with Wistar rats was performed with dosages of 0%, 2%, 8% drug diet. In treatments with 8% drug diet reduced body weight gain was observed. Gross pathology and histopathology revealed no abnormal findings. Mongrel dogs were dosed with Methy-4-hydroxy benzoate in gelatine capsules. The highest dose group received 1000 mg/kg bw per day for 6 days a week for at least 378 days. Clinical observations, body weights, haematology, urine analysis, gross pathology and histopathology revealed no abnormalities.
Phamacokinetic investigations showed that Metyl-4 -hydroxy benzoate is transformed to 4-HBA in the body. Therefore, these studies can be used to assess carcinogenic effects of 4-HBA. Please refer to the detailed justification of the read across approach in the separate read across rationale annexed to the Chemical Safety Report (in section 13 of IUCLID). As the studies with repeated administration revealed toxicity at lower dose levels, these levels are also taken for evaluation of carcinogenicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.