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EC number: 209-091-3 | CAS number: 555-32-8
- 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:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- See "Principles of method if other than guideline"
- Principles of method if other than guideline:
- Exposure started gestation day 6 (recommended start on day 5), dose level choice not justified (highest dose tested did not induce maternal effects), number of corpora lutea not determined, limited information on test substance included in report. No information on feed and environmental conditions, no analytical verification of doses, only average fetus weight males and females together per litter, no individual information on the pups, no historical control data, limited maternal toxicity parameters.
- GLP compliance:
- no
- Remarks:
- Study performed before GLP principles were implemented
- Limit test:
- no
Test material
- Reference substance name:
- Sodium benzoate
- EC Number:
- 208-534-8
- EC Name:
- Sodium benzoate
- Cas Number:
- 532-32-1
- Molecular formula:
- C7H6O2.Na
- IUPAC Name:
- Sodium benzoate
- Test material form:
- solid: particulate/powder
- Remarks:
- Fine white powdered material
- Details on test material:
- Name in the report: FDA 71-37
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- other: Golden hamster
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Individually housed in mesh bottom cages
- Diet: ad libitum
- Water: fresh tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- The cages were kept in temperature and humidity-controlled quarters
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Animals were dosed at 1.0 mL/kg bw.
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Virgin adult female hamsters were mated with young adult males (1:1), and appearance of motile sperm was considered day 0 of gestation.
- Duration of treatment / exposure:
- Gestation day 6 to 10
- Frequency of treatment:
- Daily
- Duration of test:
- Hamsters were sacrificed on gestation day 14.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 14 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 65 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Pregnant females: 22 (negative control), 21 (positive control), 22 (group exposed to 3.0, 14.0 and 65.0 mg/kg bw/day), 21 (group exposed to 300.0 mg/kg bw/day).
- Control animals:
- yes
- yes, sham-exposed
Examinations
- Maternal examinations:
- Body weights were recorded on days 0, 8, 10, and 14 of gestation. All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant females.
- Ovaries and uterine content:
- On day 14 all dams were subjected to Caesarean section under surgical anesthesia, and the numbers of corpora lutea, implantation sites, resorption sites, and live and dead fetuses were recorded. The urogenital tract of each dam was examined in detail for anatomical normality.
- Fetal examinations:
- The number of live and dead fetuses was recorded. The body weights of the live pups were recorded. The sex of all pups was determined.
All fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses of each litter underwent detailed visceral examinations employing 10X magnification. The remaining two-thirds were cleared in potassium hydroxide (KOH), stained with alizarin red S dye and examined for skeletal defects.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No mortality occurred in the control group and in the groups exposed to 14.0, 65.0 and 300.0 mg/kg bw/day. One female died in the group exposed to 3.0 mg/kg bw/day (killed on day 13 after abortion).
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weight increase of pregnant dams was comparable between the groups exposed to sodium benzoate and the control group.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- One female exposed to 3.0 mg/kg bw/day aborted on day 13. This was considered to be incidental and not related to the test item exposure. No other abortions were observed in the groups exposed to the test item or in the control group.
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- The average number of corpora lutea per dam was 15.7, 15.2, 14.7, 14.9 and 15.1 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The average number of implantation sites per dam was 13.2, 11.6, 11.9, 12.2 and 12.3 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The average number of live fetuses per dam were 12.9, 11.1, 11.3, 11.8 and 11.9 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The exposure to the test substance did not have an effect on implantation loss.
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- All pregnant dams had live litters.
- Early or late resorptions:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The total number of resorptions was 6, 8, 12, 8 and 9 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. The percentage of dams with partial resorptions was 27.3%, 23.8%, 40.9%, 31.8% and 28.6% for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
- Dead fetuses:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The total number of dead fetuses was 2, 2, 2, 2 and 1 for the negative control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
- Changes in number of pregnant:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female exposed to 3.0 mg/kg bw/day aborted on day 13. This was considered to be incidental and not related to the test item exposure. No other abortions were observed in the groups exposed to the test item or in the control group.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks on result:
- other: No adverse effects observed up to and including the highest dose tested.
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The average fetus weight was 1.81, 1.84, 1.80, 1.84 and 1.86 g for the control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratio (M/F) for the live fetuses was 0.45, 0.52, 0.45, 0.62 and 0.43 for the control group and the groups exposed to 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day, respectively. All values for the exposed groups were comparable to the sex ratio in the control group.
- External malformations:
- no effects observed
- Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The number of skeletal malformations in the exposed groups did not differ from the control group (results summarized below) and/or did not show a dose-related increase and were therefore considered not to be related to the test item.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No soft tissue abnormalities were observed in any of the groups.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects seen up to and including the highest dose tested
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
|
Control |
3.0 mg/kg bw/day |
14.0 mg/kg bw/day |
65.0 mg/kg bw/day |
300.0 mg/kg bw/day |
Live fetuses examined (pregnant dams) |
195/22 |
163/21 |
171/22 |
178/22 |
171/21 |
Sternebrae |
|||||
incomplete ossification |
101/22 |
85/20 |
98/21 |
102/21 |
92/21 |
Bipartite |
18/14 |
20/13 |
22/16 |
23/16 |
14/10 |
Extra |
- |
- |
6/1 |
- |
1/1 |
Missing |
18/11 |
7/5 |
32/13 |
17/8 |
14/8 |
Ribs |
|||||
More than 13 |
20/15 |
35/17 |
34/16 |
23/11 |
29/20 |
Vertebrae |
|||||
Incomplete ossification |
- |
- |
3/3 |
- |
- |
Extremities |
|||||
Incomplete closure |
- |
- |
2/2 |
1/1 |
- |
Miscellaneous |
|||||
Hyoid, missing |
- |
- |
5/2 |
- |
- |
Hyoid, reduced |
- |
- |
- |
- |
1/1 |
Numerator = number of foetuses affected; Denominator = Number of litters effected
Applicant's summary and conclusion
- Conclusions:
- Hamsters were exposed to sodium benzoate at 0, 3.0, 14.0, 65.0 and 300.0 mg/kg bw/day via oral gavage for 10 consecutive days during pregnancy (gestation days 6 to 15). At sacrifice on day 14, No effects were seen in maternal animals or fetuses. The nature and number of skeletal abnormalities in the test groups did not differ from the controls. No soft tissues abnormalities were observed. Based on these results, it is concluded that the NOAEL (maternal and development) is at least 300 mg/kg bw/day in hamsters.
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