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EC number: 228-973-9 | CAS number: 6381-77-7
- 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: Adequate documentation of protocol and results.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
- Reference Type:
- publication
- Title:
- Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate, Erythorbic Acid, and sodium Erythorbate
- Author:
- F. Alan Andersen, Cosmetic Ingredient Expert Review Panel
- Year:
- 1 999
- Bibliographic source:
- International Journal of Toxicology 1999 18 (suppl. 3): 1-26
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- EC Number:
- 228-973-9
- EC Name:
- 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone
- Cas Number:
- 6381-77-7
- Molecular formula:
- C6H8O6.Na
- IUPAC Name:
- sodium (2R)-2-[(1R)-1,2-dihydroxyethyl]-4-hydroxy-5-oxo-2,5-dihydrofuran-3-olate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FDA 71-68 (Sodium erythorbate)
- Physical state: Fine white powdered material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Adult
- Housing:Individually in mesh-bottom cages
- Diet: ad libitum
- Water: Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature controlled
- Humidity (%): Humidity controlled
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on mating procedure:
- Females were mated with young adult males and observation of the vaginal sperm plug was considered Day 0 of gestation. (One male was not permitted to impregnate more than one female per group).
- Duration of treatment / exposure:
- Days 6-15 days of gestation
- Duration of test:
- All dams were subjected to caesarean section on day 20.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
9.0, 41.8, 194.0, or 900.0 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- Positive control: 22 animals
0, 900 mg/kg bw/day: 24 animals
9, 41.8 mg/kg bw/day: 20 animals
194 mg/kg bw/day: 21 animals - Control animals:
- yes, sham-exposed
- other: Positive control (Aspirin 250 mg/kg bw/day)
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily for appearance and behaviour
BODY WEIGHT: Yes
- Time schedule for examinations: Day 0, 6, 11, 15 and 20
FOOD CONSUMPTION: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 20
- Organs examined: Urogenital tract was examined for anatomical abnormality. - Ovaries and uterine content:
- Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
-Other: live and dead fetuses
See Table 1:Reproductive and developmental toxicity of Sodium Erythorbate in Wistar rats - Fetal examinations:
- - External examinations: Yes: [all per litter]. All fetuses were examined grossly for presence of external congenital abnormalities.
- Soft tissue examinations: Yes:. One third of the fetuses of each litter underwent detailed visceral examinations employing the Wilson technique.
- Skeletal examinations: Yes: The remaining two third of fetuses were cleared in potassium hydroxide, stained with Alizarin Red S dye and examined for skeletal defects.
- Head examinations: Yes
-Other: Body weight of live pups - Indices:
See Table 1:Reproductive and developmental toxicity of Sodium Erythorbate in Wistar rats
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no data
Details on maternal toxic effects:
No statistically significant differences were observed in number of pregnancies, corpus lutea, implantation rates, live births, resorptions, dams with >1 site resorbed, dams with all sites resorbed, % partial resorptions, complete resorptions, number live fetuses (average/dam) betwen treated and control groups. Abnormalities were observed in rats given aspirin.
See Table 1:Reproductive and developmental toxicity of Sodium Erythorbate in Wistar rats and Appendix II - Individual Reproduction Data
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 900 mg/kg bw/day
- Basis for effect level:
- maternal abnormalities
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No statistically significant differences in average fetus weight or number of live fetuses examined at term in rats of the negative control group or in rats given Sodium Erythorbate. No gross, skeletal or soft tissue morphological abnormalities were observed in rats of the negative control group or in rats given Sodium Erythorbate. Abnormalities were observed in rats given aspirin.
See Table 1:Reproductive and developmental toxicity of Sodium Erythorbate in Wistar rats and Appendix II - Individual Reproduction Data
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 900 mg/kg bw/day
- Basis for effect level:
- reduction in number of live offspring
- changes in litter size and weights
- skeletal malformations
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1:Reproductive and developmental toxicity of Sodium Erythorbate in Wistar rats
Endpoint |
|
|
Treatment group |
|
|
|
Negative control |
Positive control |
9.0 mg/kg bw/day |
41.8 mg/kg bw/day |
194.0 mg/kg bw/day |
900.0 mg/kg bw/day |
|
Pregnancies (total no./no. to term) |
20/20 |
20/20 |
20/20 |
20/20 |
20/20 |
20/20 |
No. corpora lutea (average/dam) |
268 (11.2) |
252 (11.5) |
266 (13.3) |
257 (12.9) |
270 (12.9) |
254 (10.6) |
No. live litters |
19 |
20 |
20 |
20 |
20 |
20 |
No. implant sites (average/dam) |
244 (12.2) |
227 (11.4) |
237 (11.9) |
233 (11.7) |
238 (11.9) |
234 (11.7) |
No. resorptions |
13 |
46 |
2 |
2 |
3 |
4 |
Dams with >1 site resorbed |
5 |
11 |
2 |
2 |
3 |
4 |
Dams with all sites resorbed |
1 |
|
|
|
|
|
% Partial resorptions |
25.0 |
55.0 |
10.0 |
10.0 |
15.0 |
20.0 |
% Complete resorptions |
0.96 |
1.10 |
0.82 |
0.94 |
0.84 |
1.09 |
No. live fetuses (average/dam) |
231 (11.6) |
181 (9.05) |
235 (11.8) |
231 (11.6) |
230 (11.5) |
230 (11.5) |
M/F ratio |
0.96 |
1.10 |
0.82 |
0.94 |
0.84 |
1.09 |
No. dead fetuses |
|
|
|
|
5 |
|
Dams with >1 dead |
|
|
|
|
1 |
|
Dams with all dead |
|
|
|
|
|
|
% Partial dead |
|
|
|
|
5.00 |
|
% All dead |
|
|
|
|
|
|
Average fetus weight (g) |
3.95 |
2.62 |
3.96 |
3.95 |
3.87 |
3.92 |
Live fetuses examined at term* |
161/19 |
129/20 |
166/20 |
161/20 |
160/20 |
161/20 |
Stemebrae-incomplete ossification |
28/10 |
52/16 |
55/15 |
21/11 |
56/16 |
27/14 |
Stemebrae-bipartite |
|
11/6 |
|
|
|
|
Stemebrae-fused |
|
1/1 |
|
|
|
|
Stemebrae-extra |
|
2/2 |
|
|
|
|
Stemebrae-missing |
8/2 |
106/20 |
13/5 |
8/5 |
21/10 - |
4/4 |
Ribs-incomplete ossification |
|
19/8 |
|
|
|
1/1 |
Ribs-fused/split |
|
5/3 |
|
|
|
|
Ribs-wavy |
18/8 |
52/14 |
8/5 |
14/7 |
8/5 |
12/4 |
Ribs->13 |
4/3 |
39/14 |
2/1 |
|
2/2 |
2/1 |
Vertebrae-incomplete ossification |
7/2 |
60/16 |
|
|
7/4 |
1/1 |
Vertebrae-extra centers of ossification |
|
2/1 |
|
|
|
|
Skull-incomplete closure |
30/12 |
54/15 |
17/10 |
16/8 |
15/5 |
26/13 |
Skull-missing |
|
1/1 |
|
|
|
|
Extremities-incomplete ossification |
|
7/2 |
|
|
|
|
Miscellaneous-hyoid missing |
22/9 |
52/16 |
16/8 |
19/9 |
16/8 |
23/11 |
Miscellaneous-hyoid reduced |
21/11 |
5/2 |
15/10 |
15/7 |
14/7 |
14/10 |
*Numerator = number of fetuses affected; denominator = number of litters affected.
Study report attachments:
Appendix II - Individual Reproduction Data
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 900 mg/kg bw/day of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone to pregnant Wistar rats had no clearly discernible effect on nidation or on maternal or fetal survival.
- Executive summary:
In a developmental toxicity study (FDABF-GRAS-350) 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was administered to groups of Wistar rats by gavage at dose levels of 0.0, 9.0, 41.8, 194.0, or 900.0 mg/kg bw/day from days 6 through 15 of gestation.
No statistically significant differences were observed in number of pregnancies, corpus lutea, implantation rates, live births, resorptions, dams with >1 site resorbed, dams with all sites resorbed, % partial resorptions, complete resorptions, number live fetuses (average/dam) betwen treated and control groups. The maternal NOAEL is 900 mg/kg bw/day.
There were no treatment-related effects in developmental parameters (average fetus weight, number of live fetuses, gross, skeletal or soft tissue morphological abnormalities) The developmental NOAEL is 900 mg/kg bw/day.
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