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Diss Factsheets
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EC number: 225-714-1 | CAS number: 5026-62-0
- 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
- Endpoint:
- carcinogenicity
- Remarks:
- subcutaneous
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- published: June 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptably documented study which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the carcinogenicty of this substance.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Guideline:
- other: performed before guideline
- Principles of method if other than guideline:
- To determine the carcinogenic potential of Methylparaben the substance was injected twice weekly at different dosages for 1 year. Each animal was sacrificed and autopsied at 12 or 18 months on test period.
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
Test material
- Reference substance name:
- Methyl 4-hydroxybenzoate
- EC Number:
- 202-785-7
- EC Name:
- Methyl 4-hydroxybenzoate
- Cas Number:
- 99-76-3
- Molecular formula:
- C8H8O3
- IUPAC Name:
- methyl 4-hydroxybenzoate
- Details on test material:
- The test compound was provided by the Division of Biologic Standards, National Institutes of Health
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Caesarean derived 4-weeks-old weanlings
- weight: approx. 60 g on arrival
- placed on test within 2 weeks after arrival
- housing: 2 in a cage in air-conditioned quarters
- maintained on Purina Rat Chow and water ad libitum
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- physiological saline
- Details on exposure:
- The treatment consisted of twice-weekly injections for 52 weeks, with the dose level maintained on the mg/kg bw basis by adjusting the injection volumes to the animal weights.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Methylparaben was formulated every 2 weeks and only used for 2 weeks.
- Duration of treatment / exposure:
- 52 weeks
- Frequency of treatment:
- Twice weekly
- Post exposure period:
- 6 months
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.6 mg/kg bw/application
Basis:
other: s.c., twice weekly
- Remarks:
- Doses / Concentrations:
1.1 mg/kg bw/application
Basis:
other: s.c., twice weekly
- Remarks:
- Doses / Concentrations:
2.0 mg/kg bw/application
Basis:
other: s.c., twice weekly
- Remarks:
- Doses / Concentrations:
3.5 mg/kg bw/application
Basis:
other: s.c., twice weekly
- No. of animals per sex per dose:
- - 0.6 mg/kg bw/application: 20 animals
- 1.1 mg/kg bw/application: 40 animals
- 2.0 mg/kg bw/application: 60 animals
- 3.5 mg/kg bw/application: 80 animals - Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
- yes, historical
- Details on study design:
- - The treatment consisted of twice-weekly injections for 52 weeks, with the dose level maintained on the mg/kg bw basis by adjusting the injection volumes to the animal weights.
- After 52 weeks of treatment the animals were kept for observation an additional 6 months.
- 3 types of controls were used: a) vehicle control (60 males, 60 females) received twice weekly injections of saline at 0.25 mL per injection; b) negative controls (60 males and 60 females) received no treatment; c) positive controls (Ni3S2,4 groups of 40 animals each) - Positive control:
- Positive controls (80 males and 80 females) received predetermined fixed doses of Nickel sulfide, the positve controls were divided into subgroups: A, B, C, and D of 40 animals each (20 males, 20 females). Each animal in the A and B groups received a single subcutaneous injcetion of 10.0 and 3.3 mg, respectively. Groups C and D were given the same doses of Nickel sulfide by a single intramuscular injection in the thigh.
Examinations
- Observations and examinations performed and frequency:
- Animals were examined each day, all abnormalities were reported immediately.
A weekly record was kept of animal weights, injection volumes and gross observations. - Sacrifice and pathology:
- All experimental animals were necropsied after they died or were sacrificed (after 18 months). Organ weights were obtained and selected tissue was preserved for histopathologic studies.
- Other examinations:
- All spontaneous deaths, moribund animals, and those showing gross pathology or abnormal organ weights were examined histopathologically in addition to those chosen for routine examination.
- Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Mortality:
At the end of one year, the mortality of the treated groups did not exceed that of the negative and vehicle controls. This was confirmed after 18 months at study termination.
Histopathology:
No remarkable effects. - Relevance of carcinogenic effects / potential:
- No significant carcinogenic effects observed.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 3.5 other: mg/kg bw/application
- Sex:
- male/female
- Basis for effect level:
- other: No evidence for carcinogencity.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOEL
- Effect level:
- 3.5 other: mg/kg bw/application
- Sex:
- male/female
- Basis for effect level:
- other: No obvious toxicity
- Remarks on result:
- other: Effect type: toxicity (migrated information)
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Methylparaben did not show any carcinogenic properties under the conditions described.
- Executive summary:
The toxic and carcinogenic potential of Methylparaben was studied in rats. Methylparaben application up to 1 year and 3.5 mg/kg bw/application did not show any increase in tumor inicidence. The concurrent positive control (Nickel sulfide) induced tumors.
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