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EC number: 235-795-5 | CAS number: 12738-64-6
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The study by Onodera et a. (1978) is referenced as a key study for the assessment of teratogenicity of benzoic acid in the expert evaluation fo benzoic acid by ECHA/RAC (2012)
Data source
Reference
- Reference Type:
- other: Background document for RAC oppinion on benzoic acid
- Title:
- Background document to the Opinion proposing harmonised classification and labelling at EU level of Benzoic acid, CHL report
- Author:
- Committee for Risk Assessment, RAC
- Year:
- 2 012
- Bibliographic source:
- Background document to the Opinion proposing harmonised classification and labelling at EU level of Benzoic acid, CHL report, Committee for Risk Assessment, RAC, November 2012, ECHA/RAC/CLH-O-0000001687-65-02/A1
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The study was referenced as a key study of teratogenicity in benzoic acid in the expert evaluation fo benzoic acid by ECHA/RAC (2012)
- GLP compliance:
- no
- Remarks:
- Study was performed before 1. of June 2008
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
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Oral, dietary, from day 1 to 20 of gestation
- Duration of treatment / exposure:
- day 1 to 20 of gestation
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 600 mg/kg bw/day
- Dose / conc.:
- 1 130 mg/kg bw/day
- Dose / conc.:
- 1 610 mg/kg bw/day
- Dose / conc.:
- 1 820 mg/kg bw/day
- No. of animals per sex per dose:
- 12-18
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality increased at 1610 mg/kg/day
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Bodyweight was decreased at 1610 mg/kg/day
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food comsumption was decreased at 1610 mg/kg/day
Maternal developmental toxicity
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- Perinatal survival was decreased at 1610 mg/kg/day maternal dose
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 130 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- mortality
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Fetal weight was decreased at 1610 mg/kg/day maternal dose
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Fetal weight was decreased at 1610 mg/kg/day maternal dose - Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Perinatal survival decreased at 1610 mg/kg/day maternal dose
- Changes in postnatal survival:
- effects observed, treatment-related
- Description (incidence and severity):
- 8-wk offspring survival decreased at 1130 mg/kg/day (4.5 %, mortality: 1/22)
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- More than tenfold increase in skeletal malformations in the offsprings were increased at 1610 mg/kg/day maternal dose
- Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- More than tenfold increase in soft tissue malformations in the offsprings were increased at 1610 mg/kg/day maternal dose
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 600 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- changes in postnatal survival
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: skeletal and soft tissue malformations
- Description (incidence and severity):
- Malformations in the offsprings were increased at 1610 mg/kg/day maternal dose
Overall developmental toxicity
- Key result
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 1 610 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The teratogenicity of benzoic acid (sodium benzoate doses converted to benzoic acid equivalents) was investigated by Onodera et al. (1978) and reffered to in ECHA/RAC (2012). No increase in offspring variations and malformations was observed up to doses of ~1130 mg/kg bw/d benzoic acid administered with the food during the whole gestational period. However, a slight reduction (4.5 %, mortality: 1/22) in offspring survival was noted at this dose level. Higher doses led to reduced maternal survival, maternal bw loss, reduction in the number and weight of viable foetuses, reduced perinatal survival and a more than tenfold increase in skeletal and soft tissue malformations. A NOAEL of 1130 mg/kg bw/d benzoic acid equivalents for maternal and developmental effects and a more conservative NOAEL of 600 mg/kg bw/d for other effects on offspring is concluded.
- Executive summary:
The teratogenicity of benzoic acid (sodium benzoate doses converted to benzoic acid equivalents) was investigated by Onodera et al. (1978) and reffered to in ECHA/RAC (2012). No increase in offspring variations and malformations was observed up to doses of ~1130 mg/kg bw/d benzoic acid administered with the food during the whole gestational period. However, a slight reduction (4.5 %, mortality: 1/22) in offspring survival was noted at this dose level. Higher doses led to reduced maternal survival, maternal bw loss, reduction in the number and weight of viable foetuses, reduced perinatal survival and a more than tenfold increase in skeletal and soft tissue malformations. A NOAEL of 1130 mg/kg bw/d benzoic acid equivalents for maternal and developmental effects and a more conservative NOAEL of 600 mg/kg bw/d for other effects on offspring is concluded.
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