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EC number: 202-284-3 | CAS number: 93-89-0
- 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
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- 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
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Specific investigations
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The NOEL was determined to be 500 mg/kg bw in a chronic feeding study in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Publication includes a well documented study summary. For justification of read across see section 13.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4-generation study
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Farbwerke Bayer (Elberfeld)
- Weight at study initiation: 40-50 g
- Diet: during the first 8 weeks the rats were fed according to the pair-feeding method, afterwards food was available ad libitum
- Water: ad libitum - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with: no data - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The applied doses were analytically measured every 6 weeks.
- Duration of treatment / exposure:
- The first and second generations were exposed lifelong, the third generation was exposed until breeding.
- Frequency of treatment:
- During the first 8 weeks the rats were fed according to the pair-feeding method, afterwards food was available ad libitum.
- Remarks:
- Doses / Concentrations:
0, 0.5, 1 %,, corresponding to ca. 0, 75, 150 mg/kg bw/d
Basis:
nominal in diet - No. of animals per sex per dose:
- 20
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: no data
- Positive control:
- no data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION AND COMPOUND INTAKE:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (3rd generation)
HISTOPATHOLOGY: Yes (3rd generation) - Other examinations:
- no data
- Statistics:
- no data
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- liver weight inreases were observed in females during lactation (caused by weigth increase and variation in litter size in the 3rd generation)
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- ORGAN WEIGHTS
liver weight inreases were observed in females during lactation (caused by weigth increase and variation in litter size in the 3rd generation) - Dose descriptor:
- NOEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: An intake of 150 mg (1 %) benzoic acid per day per rat and a bodyweigth of 300 g per rat were assumed.
- Critical effects observed:
- not specified
- Conclusions:
- Rats were exposed to 0.5 and 1 % benzoic acid in a chronic feeding study. 1 % benzoic acid was equivalent to 500 mg/kg bw/day. As no effects were observed in any of the four generations, the NOEL was determined to be 500 mg/kg bw.
- Executive summary:
Rats were exposed to 0.5 and 1 % benzoic acid in two groups of 20 male and 20 female rats in a chronic feeding study. 1 % benzoic acid in the food is equivalent to 500 mg/kg bw/day. The negative control group 1 consisted of the same amount of animals and received untreated food. The first two generations were treated lifelong, the 3rd generation was treated for 16 weeks and the 4th generation until breeding. No effects were observed in any of the generations except for a liver weight increase in the females of the 3rd generation, but this increase was not considered to be caused by the treatment. On the basis of these results the NOEL for benzoic acid was concluded to be 500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- old publication on a study using a read across substance but sufficient for assessment
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
As no study on ethyl benzoate was available on this endpoint, a study conducted with benzoic acid as a suitable read across substance was used. Rats were exposed to 0.5 and 1 % benzoic acid in two groups of 20 male and 20 female rats in a chronic feeding study. 1 % benzoic acid in the food is equivalent to 500 mg/kg bw/day. The negative control group 1 consisted of the same amount of animals and received untreated food. The first two generations were treated lifelong, the 3rd generation was treated for 16 weeks and the 4th generation until breeding. No effects were observed in any of the generations except for a liver weight increase in the females of the 3rd generation, but this increase was not considered to be caused by the treatment. On the basis of these results the NOEL for benzoic acid was concluded to be 500 mg/kg bw.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
only one study available
Justification for classification or non-classification
The available data did not indicate a repeated dose toxicity of the test substance. On the basis of these data the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC (DSD) or under Regulation (EC) No 1272/2008 (CLP).
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.
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