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Diss Factsheets
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EC number: 213-361-6 | CAS number: 939-48-0
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1960-2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data reviewed by an expert panel of the OECD HPV Programme and considered "valid with restrictions." "Meets generally accepted scientific standards, well documented and acceptable for assessment. Flagged as a critical study for SIDS endpoint."
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Die Vertraglichkeit der Benzoesaure im chronischen Futterungsversuch
- Author:
- Kieckebush W and Lang K
- Year:
- 1 960
- Bibliographic source:
- Arzneimittel-Forschung 10, 1001- 1003
- Reference Type:
- review article or handbook
- Title:
- SIDS Initial Assessment Report for the 13th SIAM: Benzoates
- Author:
- OECD HPV Programme
- Year:
- 2 001
- Bibliographic source:
- http://www.inchem.org/documents/sids/sids/BENZOATES.pdf
- Report date:
- 2001
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
- Reference Type:
- review article or handbook
- Title:
- Benzoic Acid and Sodium Benzoate
- Author:
- World Health Organization
- Year:
- 2 000
- Bibliographic source:
- International Chemical Assessment Document 26: 1-48. http://www.inchem.org/documents/cicads/cicads/cicad26.pdf
- Reference Type:
- review article or handbook
- Title:
- Safety assessment of alkyl benzoates as used in cosmetics
- Author:
- Becker LC, Bergfeld WF, Belsito DV, et al.
- Year:
- 2 012
- Bibliographic source:
- Int. J. Toxicol. 31:342S-72S
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 416 Two-Generation Reproduction Toxicity
- Deviations:
- yes
- Remarks:
- Two doses (plus control) only, extends to 4 generations
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
- Reference substance name:
- Benzoic acid
- EC Number:
- 200-618-2
- EC Name:
- Benzoic acid
- Cas Number:
- 65-85-0
- IUPAC Name:
- benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Benzoic acid
- Physical state: Powder
- Analytical purity: No data
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- First 8 weeks: paired feed technique; afterwards, ad libitum.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No details provided. The mean compound consumption was calculated according to Lehman AJ, Food Drug Official Q. Bull., 66 (1954).
- Duration of treatment / exposure:
- Generations 1 & 2: lifelong.
Generation 3: 16 weeks
Generation 4: until breeding. - Frequency of treatment:
- continuously in diet
- Duration of test:
- 4 generations (48 weeks)
- No. of animals per sex per dose:
- 20 per sex per dose group. Initial body weight: 40-50 g.
- Control animals:
- yes
- Details on study design:
- Group I was dosed with 375 mg/kg.
Group II was dosed with 750 mg/kg;
An additional control group was used.
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation after 21 days 3rd generation
- Organs examined: Live fetuses were removed, examined for gross malformations, weighed, and prepared for histological examination. Skeletal examination was carried out under low magnification. - Fetal examinations:
- - External examinations: Yes:
- Head examinations: No data - Statistics:
- No abnormalities survivors rates as comparable to the control animals.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
In all 4 generations, no influence on growth (weight, weight gain and food efficiency (measured by protein efficiency)) and organ weights was found. In all 4 generations, no effects on fertility and lactation were found. No remarkable histopathological findings were found in the 3rd generation animals. In the paper no information is given on the organs investigated, however the robustness of the total study, the reputation of the investigators, as well as the reputation of the Professor who did the histopathologic investigation, a high quality has to be assumed. In addition after 48 weeks, there was no influence on start of menopause. Feeding of 375 mg/kg bw/d led to prolongation of survival compared to controls.
NOAEL (Parental) > 750 mg/kg/day
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 500 - 750 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 500 - 750 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
NOAEL (F1 Offspring) > 750 mg/kg/day
NOAEL (F2 Offspring) > 750 mg/kg/day
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No fetal effects observed.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There are differing estimates of the dose as expressed in mg/kg bw/d, which range from 500 to 750. See discussion in Kieckebush and Lang, 1960, endpoint study record under Repeated Dose Toxicity.
Applicant's summary and conclusion
- Conclusions:
- In a 4-generation study (48 weeks) reproductive toxicity study of 0.5 and 1% benzoic acid in rats by the dietary route, there were no observed adverse effects in growth, body weight, organ weights, reproductive parameters or developmental effects. The Parental and offspring NOAELs were greater than 500-750 mg/kg bw/d. This study is informative for evaluation of the toxicity of members of the Alkyl Benzoates category, and is adequate for filling the data requirement for the registration of this substance. It is valid for hazard classification and risk assessment.
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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