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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-11-21 to 2009-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: according to OECD guideline 423 performed under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-hydroxybenzoic acid
- EC Number:
- 202-804-9
- EC Name:
- 4-hydroxybenzoic acid
- Cas Number:
- 99-96-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 4-hydroxybenzoic acid
- Details on test material:
- Sponsors Batch No.: 08/1000/10,1-20
production date: 20.10.2008
purity: 99,94%
colour: white
form: powder
storage: protected from light and moisture at room temperature
CAS: 99-96-7
name of testitem (Sponsor's identification): p-Hydroxybenzoesäure
Expiry date: October 2011
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
group 1: one female rat
group 2: six female rats, tested in two groups of three rats
- Source: Elevage JANVIER (53940 Le Genest St Isle - France)
-The rats were eight weeks old, weighed between 178-212g and were housed according to guideline conditions.
- Acclimation period: at least 5 days
Their body weight was determined on day 0, 2, 7 and 14 of the examination procedure. Observations on behavior and mortality were done every day
a systematic examination was carried out on day 14. Except of day one on which food access was allowed 4 hours after test item administration,
Food and drinking water was accessible freely throughout the whole period.
A periodic cycle of continuous light (12 hours) and dark (12 hours ) was guarenteed and a temperature between 19 and 25°C.
Humidity was 30-70 % rel Humidity. The animals were kept in groups of three animals in a clear polycarbonate cage, which was filled with sawdust on the bottom, which was cleaned at least twice a week.
Administration / exposure
- Route of administration:
- other: syringe and oral administration
- Vehicle:
- DMSO
- Details on oral exposure:
- The test item was dissolved in dimethyl sulfoxide (DMSO) and the respective doses were administered by gavage in a volume of 10ml/kg b.w.
- Doses:
- group1: 5000 mg/kg b.w.
group2: 2000 mg/kg b.w. - No. of animals per sex per dose:
- 1 female rat at 5000 mg/kg b.w.
6 female animals at 2000 mg/kg b.w. in 2 groups with 3 animals - Control animals:
- other: Observations were compared to control data. It is not clearly stated if control animals were observed simultaneously besides treatments.
- Details on study design:
- one pre-test with one female using 5000 mg/kg. b.w. as dose finding
study then with two groups of three female rats using 2000 mg/kg b.w. - Statistics:
- not applicable, results and findings for each animal noted
Results and discussion
- Preliminary study:
- At 5000 mg/kg b.w. the rat died 2h 45min after administration. It was noted: thickening of the corpus , thinning of the forestomach, white particles in the stomach, grey-brown adherences in stomach , duodenum and jejunum
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- 5 000 mg/kg bw
- Remarks on result:
- other: pretest: the female rat died ca. 3h after the oral administration
- Key result
- Sex:
- female
- Dose descriptor:
- discriminating dose
- Effect level:
- >= 2 000 mg/kg bw
- Remarks on result:
- other: 2 groups of 3 female rats, no signs of toxicity
- Mortality:
- no mortality at 2000 mg/kg b.w.
- Clinical signs:
- other: no clinical signs at 2000 mg/kg b.w.
- Gross pathology:
- no abnormal findings at 2000 mg/kg b.w.
- Other findings:
- no macroscopically observable findings at 2000 mg/kg b.w.
Any other information on results incl. tables
In an acute oral dose-range finding toxicity study 1 female Sprague Dawley rat wasgiven a single oral dose of 4 -HBA of 5000 mg/kg bw. in 10 ml/kg bw. DMSO. Death was observed within 3 hours after administration.
In the following main study 2 groups of 3 female Sprague Dawley rats were given a single oral dose of 2000 mg/kg bw and observed every day for 14 days.
Oral LD50Females = higher than 2000 mg/kg bw.
No clinical signs related to the administration of the test item at 2000 mg/kg bw were observed.
The body weight evolution of the animals treated at 2000 mg/kg bw remained normal throughout the study and no treatment-related changes were revealed through macroscopical examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test substance p-Hydroxybenzoic acid is greater than 2000 mg/kg.
At 5000 mg/kg b.w. mortality occurs (pre-test with one animal)
Therefore p-Hydroxybenzoic acid does not have to be classified in category 4 according to EU-GHS criteria. - Executive summary:
In an acute oral toxicity study, in a first step 1 female Sprague Dawley rat was given a single oral dose of p-hydroxybenzoic acid at a dose of 5000 mg/kg bw. Death was observed within 3 hours after test item administration.
In a second step a group of 6 female Sprague Dawley rats were given a single oral dose of p-hydroxybenzoic acid at a dose of 2000 mg/kg bw and observed every day for 14 days.
Oral LD50Females = higher than 2000 mg/kg bw.
No clinical signs related to the administration of the test item at 2000 mg/kg bw were observed. The body weight evolution of the animals treated at 2000 mg/kg bw remained normal throughout the study and no treatment-related changes were revealed through macroscopical examination of the animals.
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