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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, reasonably well documented publication
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- , 1988
- Deviations:
- no
- Principles of method if other than guideline:
- The conduct of the sutdy was consistent to EC method B.31 (88/302/EEC) in all important aspects.
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium (E,E)-hexa-2,4-dienoate
- EC Number:
- 246-376-1
- EC Name:
- Potassium (E,E)-hexa-2,4-dienoate
- Cas Number:
- 24634-61-5
- Molecular formula:
- C6H8O2.K
- IUPAC Name:
- potassium (E,E)-hexa-2,4-dienoate
- Details on test material:
- - Name of test material: Potassium sorbate
- Physical state: Off-white powder
- Stability: the test substance was considered to be stable for the duration of the study.
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: a precise statement on the age of the test animals is lacking. Rats are transcribed as virgin adult females and young adult males.
- Weight at study initiation: 214-230 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 0, 3.4, 15.8, 73.3, 170 mg/mL
TOTAL VOLUME APPLIED: 1 mL (0, 3.4, 15.8, 73.3 mg of test substance)
2 mL (340 mg of test substance) - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Mating procedures: with young adult males (1:1); the day of copulation was considered as day 0 of pregancy.
- Duration of treatment / exposure:
- Duration of expsoure: Day 6-15 post mating
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 3.4 mg/kg bw/day
- Dose / conc.:
- 15.8 mg/kg bw/day
- Dose / conc.:
- 55 mg/kg bw/day
- Dose / conc.:
- 340 mg/kg bw/day
- No. of animals per sex per dose:
- Number of animals per group: 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 5 days
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: clinical signs
BODY WEIGHT: Yes
- Time schedule for examinations: On day 0, 6, 11, 15 and 20 of gestation
FOOD CONSUMPTION: Yes - Ovaries and uterine content:
- Parameters assessed during Caesarean section on day 20: sex, numbers of corpora lutea, implantation sites, resoption sites, live and dead fetuses, body weight of the live pups, and anatomical normality of the urogenital tract of each dam.
- Blood sampling:
- Not specified
- Fetal examinations:
- Examinations on fetuses: presence of external cogenital abnormalities, visceral examinations (Wilson technique)
- Statistics:
- Stastistical methods: not stated
- Historical control data:
- Not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Description (incidence and severity):
- Not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Details on maternal toxic effects:
The administration of up to 340 mg/kg bw of potassium sorbate had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 340 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 340 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Anogenital distance of all rodent fetuses:
- not specified
- Changes in postnatal survival:
- no effects observed
- External malformations:
- effects observed, non-treatment-related
- Skeletal malformations:
- effects observed, non-treatment-related
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
The administration of up to 340 mg/kg bw of potassium sorbate had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 340 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- > 340 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 340 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 340 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Key result
- Abnormalities:
- effects observed, non-treatment-related
- Description (incidence and severity):
- These were not different than the number reported in the sham-treated controls
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
TEST MATERIALS (POTASSIUM SORBATE) AND DOSES | ||
Dosage (mg/kg) | Dose (ml/kg) | Concentration (mg/ml) |
> 250 | 1 | > 250 |
251- 500 | 2 | 125 – 250 |
501 – 750 | 3 | 133 – 250 |
751 – 1000 | 4 | 187 – 250 |
1001 - 1600 | 5 | 200 – 250 |
Groups: 51 through 56 RATS Materia: FDA 73-4 Date: December 30, 1974 Laboratory No.: 2123 (18) |
Total |
Total | ||||
Group | Material | Dose mg/kg | Mated | Pregnant | Total | Pregnant1 |
51 | Sham | 0.0 | 25 | 20 | 24 | 19 |
52 | Aspirin* | 250.0 | 25 | 20 | 28 | 20 |
53 | FDA 73-4 | 3.4 | 23 | 20 | 27 | 20 |
54 | FDA 73-4 | 15.8 | 25 | 20 | 26 | 20 |
55 | FDA 73-4 | 73.3 | 23 | 20 | 25 | 20 |
56 | FDA 73-4 | 340.0 | 25 | 20 | 25 | 20 |
*Positive Control: 250 mg/kg **Administered as water suspension (10 ml per kg BW) 1 Includes all dams examined at term |
REPRODUCTION DATA (RATS) | ||||||
RATS Group: Dose mg/kg BW | 51 Sham | 52 Aspirin** | 53 3.4 | 54 15.8 | 55 73.3 | 56 340.0 |
Pregnancy Total No. Died or aborted (before day 20) To term(on Day 20) |
22 0 22 |
22 0 22 |
20 0 20 |
19 0 19 |
20 0 20 |
20 0 20 |
Corpora Lutea Total No. Average/dam mated |
282 11.3 |
299 12.0 |
265 11.5 |
259 10.4 |
273 11.9 |
242 9.68 |
Live Litters Total No.* |
22 |
22 |
20 |
19 |
20 |
20 |
Implant Sites Total No. Average/dam* |
257 11.7 |
251 11.4 |
244 12.2 |
222 11.7 |
240 12.0 |
233 11.7 |
Resorptions Total No.* Dams with 1 or more sites resorbed Dams with all sites resorbed Percent partial resorptions Percent complete resorptions |
-- -- -- -- -- |
51 9 -- 40.9 -- |
1 1 -- 5.00 -- |
7 4 -- 21.2 -- |
1 1 -- 5.00 -- |
4 4 -- 20.0 -- |
Live Fetuses Total No. Average/dam* Sex ratio (M/F) |
253 11.5 0.93 |
199 9.05 0.90 |
243 12.2 0.94 |
215 11.3 1.24 |
238 11.0 1.00 |
228 11.4 1.00 |
Dead Fetuses Total No.* Dams with 1 or more dead Dams with all dead Percent partial dead Percent all dead |
4 1 -- 4.55 -- |
1 1 -- 4.55 -- |
-- -- -- -- -- |
-- -- -- -- -- |
1 1 -- 5.00 -- |
1 1 -- 5.00 -- |
Average Fetus Weight, g | 3.93 | 2.40 | 4.03 | 4.08 | 4.02 | 0.86 |
*Includes only those dams examined at team **Positive Control: 250 mg/kg |
SUMMARY OF SKELETAL FINDINGS (RATS) | ||||||
| 51 | 52 | 53 | 54 | 55 | 56 |
| sham | Aspirin** | 4.6 | 21.4 | 99.1 | 460.0 |
Live Fetuses Examined (at term) | 177/22 | 145/22 | 171/20 | 150/19 | 165/20 | 163/20 |
Sternebrae Incomplete oss. Scramble Bipartite Fused Extra Missing Other |
37/14
1/1
1/1 |
96/19
11/5
1/1 130/21 |
54/16
9/5 |
58/18
1/1
2/2 |
14/9
|
34/16
1/1
12/8 |
Ribs Incomplete oss. Fused/split Wavy Less than 12 More than 13 Other |
14/7
|
7/4 91/20
131/22 |
13/9
5/4 |
15/6
1/1 |
7/3
|
22/9
1/1 |
Vertebrae Incomplete oss. Scrambled Fused Extra ctrs. oss. Scoliosis Tail defects Other |
9/6 |
106/22 |
1/1 |
3/2 |
|
3/3 |
Skull Incomplete closure Missing Craniostosis Other |
43/15 |
72/19 1/1 |
18/10 |
31/12 |
19/11 |
27/9 |
Extremities Incomplete oss. Missing Extra |
|
19/8 |
|
1/1 |
|
|
Miscellaneous Hyoid; missing Hyoid; reduced |
16/10 37/16 |
79/21 10/6 |
26/10 15/11 |
8/4 29/11 |
10/5 28/16 |
26/11 26/12 |
*Numerator = Number of fetuses affected; Denominator = Number of litters affected. **Positive control: 250.0 mg/kg |
SUMMARY OF SOFT TISSUE ABNORMALITIES (RATS) | |||||
Group | Material | Dose level (mg/kg) | Dam | Number of Pups | Description |
52 | Aspirin* | 250.0 | 44534 44538 44551 | 1 1 1 | Umbilical hernia Encephalomeningocele Umbilical hernia |
53 | FDA 73-4 | 3.4 | 44571 | 1 | Cleft palate |
*Positive control: 250.o mg/kg |
AVERAGE BODY WEIGHTS* (RATS) | |||||||
Group | Material | Dose Level Mg/kg | 0 | 6 | 11 | 15 | 20** |
51 | Sham | 0.0 | 219 | 232 | 248 | 269 | 335 (22) |
52 | Aspirin*** | 250.0 | 231 | 236 | 248 | 262 | 319 (22) |
53 | FDA 73-4 | 3.4 | 230 | 242 | 259 | 282 | 361 (20) |
54 | FDA 73-4 | 15.8 | 218 | 230 | 247 | 265 | 334 (19) |
55 | FDA 73-4 | 73.3 | 221 | 233 | 249 | 270 | 344 (20) |
56 | FDA 73-4 | 340.0 | 214 | 225 | 243 | 262 | 332 (20) |
*Of pregnant dams **Number of surviving dams in parentheses (c.f. Table 1) ***Positive control: 250.0 mg/kg |
Applicant's summary and conclusion
- Conclusions:
- LO(A)EL maternal toxic effects > 340 mg/kg b.w./day
NO(A)EL maternal toxic effects: 340 mg/kg b.w./day
LO(A)EL embryotoxic/ teratogenic effects > 340 mg/kg b.w./day
NO(A)EL embryotoxic/ teratogenic effects: 340 mg/kg b.w./day
The administration of up to 340 mg/kg bw of potassium sorbate had no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.
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. - Executive summary:
Potassium sorbate was not teratogenic in rats under the conditions of the study.
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