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EC number: 209-091-3 | CAS number: 555-32-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A feeding study was performed, in which 4 generations of rats received benzoic acid (0, 0.5 or 1%). Body weight development was determined for each generation. Reproduction parameters were assessed (number of pups, survival of pups, fertility, litter size). Rats of the F2 generation were sacrificed at 16 weeks of age. Weights of brain, heart, liver, spleen, kidneys and testes were measured. Histopathological examination was performed (F2 generation).
- GLP compliance:
- no
- Remarks:
- test performed before GLP principles were implemented
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bayer
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not specified
- Weight at study initiation: 40-50 g
- Housing: double cages
- Diet: Standard rodent diet (Latz, Euskirchen), first 8 weeks "paired feed"-technique, otherwise ad libitum
- Water: ad libitum - Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on mating procedure:
- At the age of 11-12 weeks, one male and one female from the same dose group were paired. The male and female were co-housed for 2 weeks. In case the female was not pregnant, this pocedure was repeated after 8 weeks. The females were paired at 48 weeks to detect delay in menopause. After successful mating, pups were counted on day 1, 2 and 21.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 generations
- Frequency of treatment:
- Continuous exposure through feed
- Dose / conc.:
- 0.5 other: %
- Remarks:
- Corresponds to appr. 200 mg/kg bw/day
- Dose / conc.:
- 1 other: %
- Remarks:
- Corresponds to appr. 400 mg/kg bw/day
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: weekly until 8 weeks of age, otherwise monthly
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes - Postmortem examinations (parental animals):
- The F2 rats were sacrificed after week 16 and examined histopathologically. Organ weights were measured (brain, heart, liver, spleen, kidneys and testes).
- Reproductive indices:
- Number of pregnant females was recorded (all generations).
- Offspring viability indices:
- The number of live pups on PND 1, 2 and 21 were recorded (all generations).
- Mortality:
- no mortality observed
- Description (incidence):
- The average survival (F0 and F1-generation) was slightly increased in the dosed groups compared to the control groups (average lifespan in days: 785 ± 20, 899 ± 28 and 827 ± 25 for the control group and the groups dosed at 0.5% and 1,0%, respectively).
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The percentage of sterile females was 15%, 10% and 4% for the control group and the groups exposed to 0.5% and 1% in feed, respectively. The average number of pups per nest was 9.0 ± 0.33, 9.5 ± 0.26 and 9.6 ± 0.29 (after first mating, all generations) and 6.9, 7.7 and 7.5 (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively. The survival of pups after the first three weeks was slightly lower for the exposed groups (74%, 66% and 65% (after first mating, all generations) and 72%, 61% and 73% (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively). This is expected to be related to the higher number of pups, and not to the exposure to the test item. There was no effect seen on onset of menopause.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen up to and including 1% benzoic acid in feed.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen up to and including the highest dose tested.
- Key result
- Critical effects observed:
- no
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- The survival of pups after the first three weeks was slightly lower for the exposed groups (74%, 66% and 65% (after first mating, all generations) and 72%, 61% and 73% (second mating, F1 only) for the control group and the groups exposed to 0.5% and 1% in feed, respectively). This is considered to be related to the higher number of pups, and not to the exposure to the test item.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- other: F0, F1, F2 and F3
- Effect level:
- >= 1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects seen up to and including the highest dose tested.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- other: F0, F1, F2 and F3
- Effect level:
- >= 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects seen up to and including the highest dose tested.
- Key result
- Critical effects observed:
- no
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL for reproduction toxicity was established to be at least 1% in feed, which correlates to approximately 400 mg/kg bw/day.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 960
- Report date:
- 1960
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A feeding study was performed, in which 4 generations of rats received benzoic acid (0, 0.5 or 1%). Body weight development was determined for each generation. Reproduction parameters were assessed (number of pups, survival of pups, fertility, litter size). Rats of the F2 generation were sacrificed at 16 weeks of age. Weights of brain, heart, liver, spleen, kidneys and testes were measured. Histopathological examination was performed on rats of F2 generation.
- GLP compliance:
- no
- Remarks:
- test performed before GLP principles were implemented
- Limit test:
- no
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- Molecular formula:
- C7H6O2
- IUPAC Name:
- benzoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bayer
- Females nulliparous and non-pregnant: yes
- Age at study initiation: not specified
- Weight at study initiation: 40-50 g
- Housing: double cages
- Diet: Standard rodent diet (Latz, Euskirchen), first 8 weeks "paired feed"-technique, otherwise ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 generations
- Frequency of treatment:
- Continuous exposure through feed
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.5 other: %
- Dose / conc.:
- 1 other: %
- No. of animals per sex per dose:
- 20
- Details on study design:
- At the age of 11-12 weeks, one male and one female from the same dose group were paired. The male and female were co-housed for 2 weeks. In case the female was not pregnant, this pocedure was repeated after 8 weeks. The females were paired at 48 weeks to detect delay in menopause. After successful mating, pups were counted on day 1, 2 and 21.
The F0 and F1 rats were observed until death. The F2 rats were sacrificed after week 16 and examined histopathologically. Organ weights were measured (brain, heart, liver, spleen, kidneys and testes). The F3 rats were sacrificed after week 16.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Not specified
BODY WEIGHT: Yes
- Time schedule for examinations: weekly until 8 weeks of age, otherwise monthly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
Results and discussion
Results of examinations
- Mortality:
- no mortality observed
- Description (incidence):
- The average survival (F0 and F1-generation) was slightly increased in the dosed groups compared to the control groups (average lifespan in days: 785 ± 20, 899 ± 28 and 827 ± 25 for the control group and the groups dosed at 0.5% and 1,0%, respectively).
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen up to and including 1% benzoic acid in feed.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen up to and including highest dose tested.
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Based on the default values as proposed in TNO V98 report the average body weight rat in a chronic study is appr. 375 g (male and female). According to the authors, the average intake was approximately 150 mg benzoic acid/ rat, which corresponds to an exposure of appr. 400 mg/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of a feeding study with benzoic acid over 4 generations, the NOAEL was established to be at least 1% in feed, which correlates to approximately 400 mg/kg bw/day.
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