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EC number: 203-564-8 | CAS number: 108-24-7
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP status not known, near guideline study, published in peer reviewed literature, limitations in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Acetic acid
- EC Number:
- 200-580-7
- EC Name:
- Acetic acid
- Cas Number:
- 64-19-7
- Molecular formula:
- C2H4O2
- IUPAC Name:
- acetic acid
- Details on test material:
- FDA 71-78 (Apple cider vinegar (acetic acid); table strength 5%)
Clear amber coloured liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- Virgin, adult, Dutch-belted female rabbits were individually housed in mesh bottom cages in temperature and humidity-controlled quarters with free access to food and fresh tap water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The females were dosed with the indicated dosages by oral intubations. The controls were sham treated with the vehicle at a level equivalent to the group receiving the highest test dose. The test material was prepared and doses calculated according to the following table:
Dosage Dose Concentration
(mg/kg) (ml/kg) (mg/ml)
250 1 250
251 - 500 2 125 - 250
501 - 750 3 133 - 250
751 - 1000 4 187 - 250
1001 - 1250 5 200 - 250
1251 - 1500 6 208 - 250
1501 - 1600 6.4 235 - 250 - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- On Day 0, each doe was given an injection of 0.4 ml of human chorionic gonadotropin (400 IU) via the marginal ear vein. Three hours later, each doe was inseminated artificially with 0.3 ml of diluted semen from a proven donor buck using approximately 20 x 106 motile sperm.
- Duration of treatment / exposure:
- Days 6 - 18 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- Days 0-29 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.5 mg/kg bw/day (nominal)
- Dose / conc.:
- 16 mg/kg bw/day (nominal)
- Dose / conc.:
- 74.3 mg/kg bw/day (nominal)
- Dose / conc.:
- 345 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Approximately 12 pregnant females.
- Control animals:
- yes, sham-exposed
- Details on study design:
- An additional group of mated females was dosed with 2.5mg/kg 6-aminonicotinamide on day 9 and served as a positive control
Examinations
- Maternal examinations:
- Body weights were recorded on Days 0, 6, 12, 18, and 29 of gestation.
All animals were observed daily for appearance and behaviour with particular attention to food consumption and weight, in order to rule out any abnormalities which may have occurred as a result of anorexic effects in the pregnant female animal - Ovaries and uterine content:
- On Day 29 all does were subjected to Caesarean section under surgical anaesthesia, and the numbers of corpora lutea, implantation sites, resorption sites and live and dead foetuses were recorded. The urogenital tract of each animal was examined in detail for normality.
- Fetal examinations:
- The body weights of the live pups were recorded. all foetuses underwent a detailed gross examination for the presence of external congenital abnormalities. The live foetuses of each litter were then placed in an incubator for 24 hours for the evaluation of neonatal survival. All surviving pups were sacrificed, and all pups examined for visceral abnormalities (by dissection). All foetuses were then cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduced bodyweight observed in dams treated with 1600 mg/kg/day.
- 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:
- 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
Maternal developmental toxicity
- Number of abortions:
- effects observed, treatment-related
- Description (incidence and severity):
- Abortions observed in all treated groups at incidences of: 0, 2, 1, 1, 2 for the 0, 16, 74.3, 345 and 1600 mg/kg/day treatment groups.
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduction in the number of live litters from females treated with 345 and 1600 mg/kg/day.
- 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 1600 mg/kg (body weight) of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal survival. Report of reduced body weight in dams at 1600 mg/kg bw/day. Some deaths or abortions occurred in all treated groups and some litter losses were reported at 345 and 1600 mg/kg/day. Maternal effects considered consequence of the bactericidal properties of, orally administered, acetic acid within the gastrointestinal tract of female rabbits.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 16 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- dead fetuses
- number of abortions
- Remarks on result:
- other:
- Remarks:
- Maternal effects considered consequence of the bactericidal properties of, orally administered, acetic acid within the gastrointestinal tract of female rabbits.
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- effects observed, treatment-related
- Description (incidence and severity):
- Reduction in the number of live offspring observed at 16, 345 and 1600 mg/kg/day.
- Changes in sex ratio:
- no effects observed
- 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
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- changes in postnatal survival
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 1600 mg/kg (body weight) to pregnant rabbits for 13 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.
- Executive summary:
In a developmental toxicity study in rabbits, apple cider vinegar, that contains 5% acetic acid, was administered by gavage at dose levels of 0, 16, 74.3, 345 and 1600 mg/kg/day for 13 consecutive days. The authors reported that administration of up to 1600 mg/kg bodyweight of the test material to dams for 13 days revealed no discernible effect on maternal or foetal survival, or on soft of skeletal tissues.
There was a reduction in pregnancy rate at the high dose and from 74.3 mg/kg/day, a dose-dependent decrease in maternal bodyweight gain in dams. Some deaths or abortions occurred in all treated groups and some litter losses were reported at 345 and 1600 mg/kg/day. Maternal effects were much more noticeable than effects on foetal development. It has been concluded that these findings are a consequence of the bactericidal properties of, orally administered, acetic acid within the gastrointestinal tract of female rabbits (EU, 2008). These effects are considered not to be a direct effect on embryonic implantation and development of acetic acid (EU, 2008). It is likely that this accounts for the apparent increased sensitivity of this species to oral administration of acetic acid.
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