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EC number: 246-376-1 | CAS number: 24634-61-5
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (GLP)
- Justification for type of information:
- Since the sorbate anion in the (eco-) toxicologically relevant moiety and its presence in dissociated or non-dissociated form is entirely determined by pH, extrapolation to potassium sorbate, the substance in question, is not considered to be restricted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1983
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Hexa-2,4-dienoic acid
- EC Number:
- 203-768-7
- EC Name:
- Hexa-2,4-dienoic acid
- Cas Number:
- 110-44-1
- Molecular formula:
- C6H8O2
- IUPAC Name:
- hexa-2,4-dienoic acid
- Details on test material:
- - Name of test material: Sorbic acid
- Physical state: solid, white powder
- Analytical purity: 99 %
- Stability under test conditions: The test substance was considered to be stable for the duration of the study.
- Storage condition of test material: dark at 4 °C
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Strain: NMRKf (SPF71)
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 27–36 g, females: 21–29 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: sesame oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): freshly prepared every day - Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- single application
- Post exposure period:
- 24, 48 or 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 500 mg/kg diet
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 1 500 mg/kg bw/day
- Remarks:
- Basis: actual ingested
- Dose / conc.:
- 5 000 mg/kg diet
- Remarks:
- Basis: actual ingested
Criteria for selection of MTD: a preliminary study reported 5000 mg/kg bw as the highest tolerable dose
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control: 50 mg/kg bw Cyclophosphamide (Endoxan ®), concentration: 50 mg/kg bw.
Examinations
- Tissues and cell types examined:
- Bone marrow:
- Number of animals: 5 per sex at each of 3 time points
- Number of cells: 1000
- Time points: 24, 48 and 72 hours after treatment
- Type of cells: Erythrocytes in bone marrow
- Parameters: Polychromatic/normo-chromatic erythrocyte ratio, occurrence of micronuclei - Evaluation criteria:
- Criteria for evaluating results: number of cells with micronuclei, PCE:NCE ratio
- Statistics:
- Statistical methods: Wilcoxon
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
- Vehicle controls validity:
- valid
- Remarks:
- Sesame oil
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks:
- Cyclophosphamide (Endoxan ®)
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- No mortalities were observed, and the only clinical sign was uncoordinated gait, which had recided 24 hours after application.
- There were no substance-related findings upon necropsy, or effects on body weight.
- Ratio of PCE/NCE (for Micronucleus assay): The PCE/NCE ratio was unaffected.
- Statistical evaluation: The test yielded no statistically significant increase of micronucleated polychromatic erythrocytes and normochromatic erythrocytes with micronuclei.
Any other information on results incl. tables
Table1: In-vivomicronucleus test of bone marrow cells from male mice receiving Sorbic acid, sesame oil (vehicle control) or Cyclophosphamide (positive control).
|
Positive control |
Vehicle control |
Low dose (500 mg/kg) |
Mid dose (1500 mg/kg) |
High dose (5000 mg/kg) |
||||||||
Number of cells evaluated |
5000 |
5000 |
5000 |
5000 |
5000 |
||||||||
Sampling time [h] |
24 |
24 |
48 |
72 |
24 |
48 |
72 |
24 |
48 |
72 |
24 |
48 |
72 |
No. of erythrocytes |
|
|
|
|
|
|
|
|
|
|
|
|
|
Normo-chromatic with micronuclei |
2 |
1 |
1 |
1 |
2 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
Polychromatic with micronuclei |
32* |
2 |
1 |
0 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
2 |
Ratio of erythrocytes |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polychromatic/ normo-chromatic |
0.97 |
0.93 |
0.90 |
0.94 |
0.98 |
0.89 |
1.02 |
0.98 |
0.90 |
1.12 |
1.05 |
0.95 |
0.99 |
*) significantly different from control (p < 0.05) |
Table2: In-vivomicronucleus test of bone marrow cells from female mice receiving Sorbic acid, sesame oil (vehicle control) or Cyclophosphamide (positive control).
|
Positive control |
Vehicle control |
Low dose (500 mg/kg) |
Mid dose (1500 mg/kg) |
High dose (5000 mg/kg) |
||||||||
Number of cells evaluated |
5000 |
5000 |
5000 |
5000 |
5000 |
||||||||
Sampling time [h] |
24 |
24 |
48 |
72 |
24 |
48 |
72 |
24 |
48 |
72 |
24 |
48 |
72 |
No. of erythrocytes |
|
|
|
|
|
|
|
|
|
|
|
|
|
Normo-chromatic with micronuclei |
1 |
1 |
0 |
1 |
0 |
1 |
1 |
0 |
1 |
0 |
1 |
0 |
0 |
Polychromatic with micronuclei |
21* |
1 |
2 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
2 |
2 |
1 |
Ratio of erythrocytes |
|
|
|
|
|
|
|
|
|
|
|
|
|
Polychromatic/ normo-chromatic |
0.89 |
0.99 |
1.17 |
1.00 |
0.94 |
1.12 |
1.14 |
0.94 |
1.22 |
1.24 |
1.13 |
1.05 |
1.15 |
*) significantly different from control (p < 0.05) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Treatment with Sorbic acid did not cause any increase in the number of micro-nucleated polychromatic erythrocytes and micro-nucleated normo-chromatic erythrocytes at any of the three sampling times at either dose level. Statistically significant increases in the number of polychromatic cells with micronuclei were observed in positive control animals treated with 50 mg/kg bw Cyclophosphamide. Sorbic acid was not genotoxic under the conditions of this test.
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