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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Read-across from data on benzoic acid as evaluated by ECHA/RAC (2012)
see read-across justification attached in section 13.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- No data is available for sucrose benzoate. Therefore data on benzoic acid is used for read-across. For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across to data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose (see toxicokinetic section and read-across justification attached in section 13).
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- Key result
- Critical effects observed:
- no
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- No data is available for sucrose benzoate. Therefore data on benzoic acid is used for read-across purposes.
For benzoic acid reproductive toxicity was assessed in a non-guideline 3-generation study performed in rats with 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d. These doses failed to produce detectable toxic effects on parental and offspring generations or reproductive capacity (ECHA/RAC 2012). For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across from data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose (see toxicokinetic section). Based on lack of effects on fertility of benzoic acid, no concern can be concluded for sucrose benzoate as well. - Executive summary:
No data is available for sucrose benzoate. Therefore data on benzoic acid is used for read across purposes.
For benzoic acid reproductive toxicity was assessed in a non-guideline 3-generation study performed in rats with 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d. These doses failed to produce detectable toxic effects on parental and offspring generations or reproductive capacity (ECHA/RAC 2012). For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across from data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose (see toxicokinetic section). Based on lack of effects on fertility of benzoic acid, no concern can be concluded for sucrose benzoate as well.
Reference
Additional information
No data is available for sucrose benzoate. Therefore data on benzoic acid is used for read across purposes.
For benzoic acid reproductive toxicity was assessed in a non-guideline 3-generation study performed in rats with 0, 0.5 and 1% benzoic acid added to the diet, corresponding to approximate doses of 0, 250 and 500 mg/kg bw/d. These doses failed to produce detectable toxic effects on parental and offspring generations or reproductive capacity (ECHA/RAC 2012).
Based on lack of effects on fertility of benzoic acid, no concern can be concluded for sucrose benzoate as well.
Effects on developmental toxicity
Description of key information
Read-across from data on benzoic acid as evaluated by ECHA/RAC (2012)
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- No data is available for sucrose benzoate. The evaluation is therefore based on read across from data on benzoic acid, For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across to data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose. See also toxicokinetic section and read-across justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Key result
- Abnormalities:
- no effects observed
- 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
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: soft tissue and skeletal
- Description (incidence and severity):
- Effects observed at 1610 mg/kg/day (maternal dose)
- 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
- Conclusions:
- No data is available for sucrose benzoate. Therefore the conclusion is based on read across from benzoic acid.
Based on three developmental toxicity studies on benzoic acid/ benzoate using dose levels in the range of 50 – 1610 mg/kg/d RAC concluded benzoic acid not to be classified for developmental toxicity as no developmental effects occurred even at highly maternal toxic levels (ECHA/RAC 2012).
For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across to data on benzoic acid is considered relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose (see toxicokinetic section).
Based on lack of effects on fertility and development of benzoic acid, no concern can be concluded for sucrose benzoate as well. - Executive summary:
No data is available for sucrose benzoate. Therefore the concludion is based on read across to benzoic acid.
Based on three developmental toxicity studies on benzoic acid/ benzoate using dose levels in the range of 50 – 1610 mg/kg/d RAC concluded benzoic acid not to be classified for developmental toxicity as no developmental effects occurred even at highly maternal toxic levels (ECHA/RAC 2012).
For inducing reproductive toxicity the substance has to be absorbed in order to reach the sex organs and the embryo/ foetus. Therefore, read-across to data on benzoic acid is considered especially relevant as exposure to sucrose benzoate would not lead to systemic exposure to sucrose benzoate but benzoic acid and sucrose (see toxicokinetic section).
Based on lack of effects on fertility and development of benzoic acid, no concern can be concluded for sucrose benzoate as well.
Reference
Additional information
Read-across data on benozic acid:
Doses up to 500 mg/kg bw/d did not produce detectable adverse effects on
development of the offspring or on sexual function or fertility in parental animals. No
increase in offspring variations and malformations was observed up to doses that
produced maternal toxicity (> 1000 mg/kg bw/d benzoic acid). In a single study, a 4.5
% offspring mortality (1/22) was observed at the highest dose level (~1130 mg/kg
bw/d benzoic acid) administered with the food during the whole gestational period (ECHA/RAC 2012).
Justification for classification or non-classification
Based on the availble information benzoic acid is according to RAC (2012) not to be classified for reproductive toxicity.
Based on read-across from the data on benzoic acid the substance sucrose benzoate is not to be classified for reproductive toxicity.
Additional information
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