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EC number: 205-126-1 | CAS number: 134-03-2
- 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
The available information does not show adverse effects on fertility. Information on this endpoint is waived because a valid prenatal developmental toxicity study in the rat is available (cf. regulation (EC) No. 1907/2006, Appendix VIII, No. 8.7.1, column 2).
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
The substance has no potential for reproductive toxicity. The NOAEL was determined to be 1125 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- pre-guideline study; no differentiation of early or late resorptions
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Species:
- rat
- Strain:
- Wistar
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- M/F ratio per cage: 1/4
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Duration of treatment / exposure:
- first trial: GD 6-15
second trial: GD 0 to day 21 p.p. - Frequency of treatment:
- 7/week
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Control group
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Remarks:
- Lowest dose group
- Dose / conc.:
- 250 mg/kg bw/day (actual dose received)
- Remarks:
- low dose group
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- mid dose group
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- high dose group
- No. of animals per sex per dose:
- Historical controls: 760 dams
Concurrend control: 21 dams
Lowest dose group: 22 dams
Low dose group: 19 dams
Mid dose group: 21 dams
High dose group: 17 dams - Control animals:
- yes, concurrent vehicle
- yes, historical
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: at start and termination; body weight gain reported
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No
- Number of corpora lutea: No
- Number of implantations: Yes
- Number of early resorptions: No; sum of earla and late resorptions - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: two third per litter
- Head examinations: Yes: No data - Statistics:
- means ± SD; statistical significance; method not specified
- Indices:
- no
- Historical control data:
- yes; from 760 dams
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- 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
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- Abortions as percentage of implantations
Historical controls: 760 dams 2.2 %
Concurrend control: 21 dams 2.4 %
Lowest dose group: 22 dams 3.7 %
Low dose group: 19 dams 1.1 %
Mid dose group: 21 dams 0.9 %
High dose group: 17 dams 0.0 % - Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- not specified
- Other effects:
- not examined
- Details on maternal toxic effects:
- no toxic effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: absence of adverse effects
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not examined
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: absence of adverse effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Ascorbic acid was not maternal toxic or reprotoxic in female Wistar rats up to 1000 mg/kg bw and day
- Executive summary:
The developmental toxicity of ascorbic acid was investigated in female Wistar rats and NMRI mice in a series of pre-guideline studies.
In the first trial, the test substance dissolved in water was administered by oral gavage at dose levels of 0, 150, 250, 500 and 1000 mg/kg bw and day during GD 6-15. Caesarian section was performed at termination on GD 20. Uteri and fetuses were examined. Findings were subjected to statistical analysis. No maternal toxicity or developmental toxicity (including teratogenicity) was noted at any dose level including the top dose. Hence, the NOAEL was 1000 mg/kg bw and day in this study.
It should be noted that the same result was obtained with mice treated during GD 6-15 (data not reported in this endpoint study record).
Further, a second trial was conducted which is not reported here in full detail. Briefly, dams (24-27 per group at termination) received ascorbic acid (0, 250, 500, 1000 mg/kg bw and day) by oral gavage from GD 0 until day 21 post parturition. This treatment had no adverse effect on pregnancy, parturition, breeding instinct and lactation capacity of the mother animals, nor on the embryonic, foetal, and postpartum development of the progeny.
Overall, ascorbic acid at 1000 mg/bw and day was not maternal or developmental toxic in the rat. The studies were performed before the existence of a suitable test guideline, but generally meet the accepted methodology and are therefore considered to be valid and suitable for assessment.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 125 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- sufficient fior assessment
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No maternal or developmental toxicity was seen in rats and mice receiving ascorbic acid by oral gavage during GD 6-15 pregnancy at doses up to and including 1000 mg/kg bw and day, or when rats received the test substance form GD 0 until day 21 post parturition (Frohberg et al., 1973). This pre-guideline study is scientifically acceptable and valid, and suitable for assessment. The results can be adopted for sodium ascorbate. Taking the molecular weights into consideration, this corresponds to 1125 mg sodium ascorbate/kg bw and day.
This result is supported by a rat study using an insufficient number of test animals which, therefore, is rated to be invalid (reliability 3) but does support the results outlined above (Siman and Eriksson, 1997).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Based on available data on reproductive toxicity, the substance is not considered to be classified for toxicity to reproduction according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.