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Diss Factsheets
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EC number: 203-118-2 | CAS number: 103-50-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Maximum reliability for read across-studies Critical study in OECD risk assessment, 2004: Meets generally accepted scientific standards, well documented and acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- No information
- Author:
- Kieckebusch W & Lang K
- Year:
- 1 960
- Bibliographic source:
- Arzneim.-Forsch. 10: 1001-1003
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report for 13th SIAM (Bern, 7th – 9th November 2001) on Benzoates: Benzoic acid, Sodium benzoate, Potassium benzoate, Benzyl alcohol, CAS Nos. 65-85-0, 532-32-1, 582-25-2, and 100-51-6
- Author:
- OECD
- Year:
- 2 004
- Bibliographic source:
- http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?key=9d081a2b-4582-464a-99d7-27749e8b324a&idx=0
Materials and methods
- Principles of method if other than guideline:
- 4-generation diet-study. Cited from OECD risk assessment: "A robust protocol, according to standards at that time, was used. Taking into account the reputation of the investigators a high quality has to be assumed."
- GLP compliance:
- no
- 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
- Details on test material:
- benzoic acid, purity not noted
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- initial body weight:40-50 g
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Oral feed (first 8 weeks paired feed technique; afterwards ad libitum)
- Duration of treatment / exposure:
- Exposure period: generation 1 and 2: lifelong; generation 3: 16 weeks; generation 4: until breeding
- Frequency of treatment:
- Continuously in diet
- Details on study schedule:
- Lifelong (4-generations)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
approx. 375 and 750 mg/kg bw (0.5 and 1 % in diet)
Basis:
- No. of animals per sex per dose:
- 20
- Control animals:
- yes
- Details on study design:
- The mean compound consumption was calculated according to Lehman, A.J., Assoc. Food Drug Off. Q. Bull. 18, 66 (1954).
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 750 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No indications for parental toxicity at highest dose of 750 mg/kg; reference: OECD risk assessment, 2004
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 750 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No indications for fetal toxicity at highest dose of 750 mg/kg; reference: OECD risk assessment, 2004
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- >= 750 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No indications for fetal toxicity at highest dose of 750 mg/kg; reference: OECD risk assessment, 2004
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
"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 ("Fortpflanzung") and lactation ("Aufzucht der Jungen") was found. The animals of the 3rd generation were sacrificed and examined histopathologically after 16 weeks (after lactation of the pups). No remarkable histopathological findings were found.
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.
From other parameters it can be assumed that as a minimum the brains, heart, liver, kidney, testis and were examined.
Feeding of 0.5 % led to prolongation of survival compared to controls. In addition a so called "Alters-Paarung" after 48 weeks gave no influence on start of menopause."
Applicant's summary and conclusion
- Executive summary:
Cited from OECD 2004: "In a 4-generation study 20 rats/sex/group were dosed continuously by diet with 375 or 750 mg/kg/day benzoic acid. In all 4 generations, no effects on fertility (“Fortpflanzung”) and lactation (“Aufzucht der Jungen”) were found. In addition a so-called “Alters-Paarung” after 48 weeks gave no influence on start of menopauze. NOAEL (Parental) > 750 mg/kg/day, NOAEL (F1 Offspring) > 750 mg/kg/day, NOAEL (F2 Offspring) > 750 mg/kg/day."
(Kieckebusch & Lang, 1960, OECD 2004)
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