Registration Dossier
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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

Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- The extrapolation from sorbic acid to potassium sorbate or vice versa is considered not to be restricted in any way, since the determinant of potential toxicity is on the "sorbate" anion.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- adopted 1995-07-27
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- adopted 1996
- Deviations:
- no
- Principles of method if other than guideline:
- The conduct of the study was consistent in all important aspects with method B.7 (96/54/EEC), OECD guideline 407 and OPPTS 870.3050 (U.S. EPA).
- GLP compliance:
- yes
- Limit test:
- no
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: White crystalline powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age: Approx. 6 weeks
- Weight at study initiation: Males: 127-155 g (mean: 141 g); females: 117-134 g (mean: 126 g)
Administration / exposure
- Route of administration:
- oral: feed
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- - Stability and homogeneity of the test compound in the diet was confirmed by HPLC analysis for 7 days.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- continuous
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25 000, 50 000 and 100 000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- Number of animals per group:
- Group 1: 10 males and 10 females (recovery: 5 males and 5 females)
- Group 2: 5 males and 5 females
- Group 3: 5 males and 5 females
- Group 4: 10 males and 10 females (recovery: 5 males and 5 females)
- Control animals: 10 males and 10 females - Control animals:
- yes, plain diet
- Details on study design:
- Post-exposure period: 15 days recovery
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: clinical signs once daily and mortality twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption: Yes (twice weekly)
- Intake of test substance: Yes (twice weekly)
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule: End of study and after recovery period (only group 1 and group 4)
- How many animals: All animals
- Parameters: Erythrocyte count, haemoglobin concentration, haematocrit, MCV, MCH, MCHC, reticulocytes, Heinz Bodies, white blood cell count, neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, coagulation time
CLINICAL CHEMISTRY: Yes
- Time schedule: End of study and after recovery periode (only group 1 and group 4)
- How many animals: All animals
- Parameters: Sodium, potassium, calcium, chloride, phosphorus, bilirubin total, bilirubin direct, glucose, uric acid, creatinine, urea nitrogen, cholesterol, triglycerides, protein total, albumin, aspartate aminotransferase, alanine aminotransferase, γ-glutamyltranspeptidase, alkaline phosphatase, albumin/globulin ratio, globulin
URINALYSIS: Yes
- Number of animals: All animals
- Time schedule: End of study
- Parameters: Volume, pH value, specific weight, bilirubin, urobilinogen, ketone bodies, glucose, protein, blood
NEUROBEHAVIOURAL EXAMINATION: Yes
- Number of animals: All animals
- Time schedule for examinations: Day 25
- Parameters: "Open field" observations, assessment of sensory function, forelimb and hindlimb grip strength. - Sacrifice and pathology:
- GROSS PATHOLOGY AND HISTOPATHOLOGY: Yes
- Number of animals: All animals
- Time points: End of study and after recovery period
- Organs: Heart, kidneys, liver, lungs, spleen, thymus, iliac lymph node, mandibular lymph node, trachea, forestomach, glandular stomach, jejunum, colon, cerebrum, cerebellum, medulla oblongata, spinal cord, sciatic nerve, adrenal cortex, adrenal medulla, thyroid gland, parathyroid glands, urinary bladder, ovaries, uterus, prostate, seminal vesicles, testes, epididymides, bone marrow
ORGAN WEIGHTS: Yes
- Number of animals: All animals
- Time points: End of study and after recovery period (only group 1 and group 4)
- Organs: Heart, liver, kidney, spleen, testes, epididymes, adrenals, brain, thymus - Statistics:
- Statistics: None
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- not applicable
- Details on results:
- - Clinical signs: No effects. An incidental finding: One mid dose group male exhibited slight alopecia between study days 15 and 24. This incident appears not to be treatment related.
- Mortality: No unscheduled deaths throughout the study.
- Body weight gain: Throughout the study the mean body weight increased in all 4 groups. Compared to the control group the overall body weight gain was slightly reduced for high dose males. On study day 4 and 11 the mean body weight of high dose males was also slightly but statistically significantly decreased. This difference was marginal, and was considered the result of massive test compound intake and loss of calories through dietary reduction. The same happened on study day 36 in high dose recovery females: The mean body weight was also statistically significantly decreased. This finding was considered as incidental.
- Food consumption and compound intake: No effects.
- Ophtalmoscopic examination: Not examined
- Neurotoxicological examinations: "Open field" observations, assessment of sensory function and forelimb and hindlimb grip strength showed no effects. The number of movements was statistically significantly reduced for low dose females. This finding was considered as incidental.
- Blood analysis:
- Haematology: No haematological effects in the final and recovery group occurred throughout the study. For high-, mid-, and low dose group males the mean haemoglobin was statistically significantly decreased compared to the control. This finding was considered as incidental. White cell count picture and the blood coagulation time in all groups at final and after recovery showed no effects.
- Clinical chemistry: No clinical chemistry effects in the final and recovery group occurred throughout the study. In several serum parameters (chloride, cholesterol, alkaline phosphatase, albumin, albumin/globulin ratio) slight but statistically significant increases could be observed for females compared to the control group. Except for albumin the values were all within the physiological range of the control data and therefore considered not to be toxicologically significant. The high dose males showed a slight but statistically significant increase of alanine aminotransferase; in addition, 1-glutamyltranspeptidase was statistically significantly decreased for high dose males when compared to the control group. This finding was considered not to be toxicologically significant. Slight statistically significant increases of calcium, phosphorus, total protein and alkaline phosphatase activity in high dose males compared to the control. No toxicological significance was shown.
- Urinalysis: No effects.
- Sacrifice and pathology:
- Organ weights: No effects on mean absolute organ weights in the final and recovery group throughout the study. The kidney of the high dose males showed a statistically significant decrease when compared to the control and the liver of the low dose, middle dose and high dose females and the thymus of the high dose females showed a statistically significant increase when compared to the control. However, as they were all within the physiological range no functional, clinical and histopathological correlation are shown. The adrenal weight of the high dose males showed statistically significant increases when compared to the control. Although the values were slightly outside the upper physiological range a histopathological correlate was not identified for this organ.
- Relative organ weights: At the end of the treatment period, the livers of the low, mid dose and high dose females, and the thymus of the mid and high dose females showed a statistically significant increase when compared to the control. These relative organ weight changes were all within the physiological range of the control data for this rat strain, gender and age. This finding was considered as incidental and not toxicologically significant.
- Gross pathology: No effects at final and recovery necropsy that could be related to administration. Only incidental findings were stated.
- Microscopic pathology: No effects at final and recovery necropsy that could be related to administration. Only incidental findings were stated.
- Other: None
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- mortality
- urinalysis
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No overt clinical signs of toxicity, no mortalities, no-treatment related effects on food consumption and no changes in neurotoxicological measurements were observed during the study. The high dose group showed a reversible trend of slightly lower overall mean body weight gains. This was considered due to palatability problems of feeding a high test compound concentration in the diet (10%). No treatment related changes in haematological, blood serum parameters and urine analysis were seen. No treatment related macroscopic or microscopic changes were identified upon necropsy.
Conclusion:
LO(A)EL: Not applicable
NO(A)EL: 100 000 ppm males and females (male: 9200 mg/kg bw/d and female: 8600 mg/kg bw/d)
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