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Diss Factsheets
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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- in 1952 or earlier
- Reliability:
- other:
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- acceptable, according to the standards of the time well-documented study which meets basic scientific principles Results are reported for 4-HBA and the read across substance Methylparaben also. For detailed read across justification please refer to the read across rationale attached to this endpoint study record. It is also attached to section 13 of iuclid as Appendix to the Chemical Safety Report. 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 and other routes of 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 detailed read across justification please refer to the read across rationale attached to this endpoint study record. It is also attached to section 13 of iuclid as Appendix to the Chemical Safety Report.)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 956
- Report date:
- 1956
Materials and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- p-hydroxybenzoic acid
- IUPAC Name:
- p-hydroxybenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): p-hydroxy-benzic acid, PHBA
A second substance was tested in comparison:
- Name of test material (as cited in study report): Methyl p-hydroxy-benzoate
- Substance type: ester
THE FOLLOWING DATA ARE NOT STATED IN THE REPORT:
- Molecular formula (if other than submission substance): C8H8O3
- Molecular weight (if other than submission substance): 152.16
- CAS number: 99-76-3
- EC number: 202-785-7
- IUPAC name: Methyl-4-hydroxy benzoate
- Physical state: solid
Constituent 1
Test animals
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- single administration of 4-HBA and Methyl paraben
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.0 g/kg bodyweight each.
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: blood,urine
- Time and frequency of sampling: 5, 15 and 30 min, 1, 2, 4, 6, 12, 24 and 48 hours
- From how many animals: 3
- Method type for identification: spectrometric
- Statistics:
- Average of 3 dogs
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Absorption is essentially complete as 94 % of pHBA of initial dose were recovered in urine.
- Details on excretion:
- An oral dosage of 4-HBA and Methyl paraben resulted in the same plasma levels of 4-HBA.
94% of an oral dosage of 1.0 g 4-HBA/kg bodyweight to dogs were recovered in the urine, 40.1% as free 4-HBA, 30.0% as glucuronic acid-conjugate. 89% of an oral dosage of 1.0 g methyl paraben/kg body weight to dogs were recovered in the urine, 21.3% as free 4-HBA, 35.1% as glucuronic acid-conjugate.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Oral dosages of 1.0 g/kg bodyweight of 4-HBA/Methyl paraben were given to groups of 3 dogs, respectively. After administration of 4-HBA and Methyl paraben the same concentrations of free 4 -HBA and the same kinetics for the elimination of 4 -HBA were found in the plasma. After the oral administration of 4 -HBA 94% of the dosage were recovered in the urine, 40.1% as free 4-HBA, 30.0% as glucoronide acid conjugate.
After the oral administration of Methyl paraben 89% of the dosage were recovered in the urine, 21.3% as free 4-HBA, 35.1% as glucoronide acid conjugate.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Executive summary:
Oral dosages of 1.0 g/kg bodyweight were given to groups of 3 dogs. After administration of 4-HBA and Methyl paraben the same concentrations of free 4 -HBA and the same kinetics for the elimination of 4 -HBA were found in the plasma.
After the oral administration of 4 -HBA 94% of the dosage were recovered in the urine, 40.1% as free 4-HBA, 30.0% as glucoronide acid conjugate.
After the oral administration of Methyl paraben 89% of the dosage were recovered in the urine, 21.3% as free 4-HBA, 35.1% as glucoronide acid conjugate.
Obviously methyl paraben is quickly degraded to 4 -HBA in the stomach.
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