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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1960
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates current guidelines. This older study meets generally accepted scientific standards. The data is published in German and has been accepted as valid by panels of toxicologists including those at JECFA, EFS and WHO.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Die vertraglichkeit der benzoesaure im chronischen futterungsversuch
- Author:
- Kieckebusch W and Lang K
- Year:
- 1 960
- Bibliographic source:
- Arzneimittel-Forschung 10: 1001-1003.
- 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:
- publication
- Title:
- Unnamed
- Year:
- 1 983
- 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
- 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:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline: 416
- Principles of method if other than guideline:
- This is a 4-generation repeated dose toxicity study of benzoic acid.
- GLP compliance:
- not specified
- Limit test:
- no
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
- Details on test material:
- no data available
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bayer-Elberfeid
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on oral exposure:
- In a 4-generation study, 20 rats/sex/group were dosed continuously with 0.5 and 1% in the diet, equivalent to 250 or 500 mg/kg/day, of benzoic acid.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Generations 1 and 2: lifelong
Generation 3: 16 weeks
Generation 4: until breeding - Frequency of treatment:
- Daily (continuous) in the diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 and 1% in the diet (estimated as 250-500 mg/kg bw/d, 275- 500 mg/kg bw/d, or 375-750 mg/kg bw/day by different expert groups)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20 per sex per group.
- Control animals:
- yes, plain diet
- Details on study design:
- Chronic repeated dose toxicity study, in which animals were allowed to mate through 4 generations. The animals of the 3rd generation were killed and examined histopathologically after 16 weeks (after lactation of the pups).
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- Animals were examined for weight, weight gain and food efficiency (measured by protein efficiency)) and organ weights.
- Sacrifice and pathology:
- HISTOPATHOLOGY:Yes
The animals of the 3rd generation were killed and examined histopathologically after 16 weeks (after lactation of the pups).
Results and discussion
Results of examinations
- 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:
- no effects observed
- 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:
- no effects observed
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No adverse effects were observed in 4 generations of rats at doses of 1% benzoic acid in the feed. There was slightly increased survival at the dose of 0.5%. No signficant findings were noted in the post-mortem examination. The NOAEL is 1% (approximately equivalent to 500-750 mg/kg bw/d).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 - 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: as 1% in the diet
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Rats were administered 0, 0.5 and 1% benzoic acid in the diet for 4 generations. No harmful effects were observed on growth, fertility, development, lactation and lifespan. The no effect dietary level was 1%, approximately equivalent to 500-750 mg/kg bw/d. This study is informative for evaluation of the toxicity and environmental fate 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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