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EC number: 206-839-0 | CAS number: 381-73-7
- 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)
Data source
Reference
- Reference Type:
- publication
- Title:
- Developmental toxicity of dichloroacetate in the rat
- Author:
- Smith M.K., Randall, J.L. Read, E.J. and Stober, J.A.
- Year:
- 1 990
- Bibliographic source:
- Teratology, 46 (3), 217-23. Year: 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The developmental toxicity effect of dichloroacetic acid to Long-Evans rat was assessed in a parental generation of rat.
- GLP compliance:
- no
Test material
- Reference substance name:
- Dichloroacetic acid
- EC Number:
- 201-207-0
- EC Name:
- Dichloroacetic acid
- Cas Number:
- 79-43-6
- IUPAC Name:
- dichloroacetic acid
- Test material form:
- other: Liquid
- Details on test material:
- - Name of test material (as cited in study report): Dichloroacetic acid
- Molecular formula (if other than submission substance): C2H2Cl2O2
- Molecular weight (if other than submission substance): 128.94
- Substance type: Organic
- Physical state: Liquid
- Impurities (identity and concentrations): -----
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Long-Evans
- Details on test animals or test system and environmental conditions:
- Source: Charles River Breeding Laboratories
Weight range: Not available
Housing: groups of three in plastic cages with corn cob bedding (Bed O'Cobs, Anderson Cob Div., Maumee, OH), and maintained on Purina Rodent Laboratory Chow No. 5001 (St. Louis, MO)
Diet (e.g. ad libitum): Purina Rodent Laboratory Chow No. 5001, ad libitum
Water: ad libitum (distilled water)
ENVIRONMENTAL CONDITIONS:
Temperature: Temp. 70-74°F
Humidity (%): 40-60%
Photoperiod: 12-h light cycle (0630 lights on).
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dosing solutions were prepared daily and their purity and stability confirmed using ion chromatography.
DCA of >99% purity was dissolved in water and adjusted to pH 7 with sodium hydroxide, such that the desired dosage, adjusted daily, could be administered at 10 ml/kg body weight.
Rate of preparation of diet (frequency):
Dosing solutions were prepared daily and their purity and stability confirmed using ion-chromatography.
Amount of dose: 10 ml/kg body weight. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1 female: 1 male
- Length of cohabitation: At 2:00 PM and checked for the presence of sperm at 9:00 AM on the following morning.
(19 Hrs)
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Sperm-positive females were considered to be in day 0 of pregnancy and were singly housed for the duration of the study.
- After … days of unsuccessful pairing replacement of first male by another male with proven fertility. Not Available
- Further matings after two unsuccessful attempts: [no / yes (explain)] Not Available
- After successful mating each pregnant female was caged (how): Not Available
- Any other deviations from standard protocol: Not Available - Duration of treatment / exposure:
- 10 days
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 14, 140 or 400 mg/kg-bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 80 rats
0mg/kg-bw/ day: 20
14 mg/kg-bw/ day: 20
140 mg/kg-bw/ day: 20
400 mg/kg-bw/ day: 20 - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Analysis of the average percent maternal weight gain from days 0-20, adjusted for gravid uterine weight, revealed a statistically significant difference from the controls in 140 and 400 mg/kg/day, but not in the lowest dose group (14 mg/kg/day).
Reductions in weight gain, particularly during the initial phases of dosing, were seen in 140 mg/kg/day except at the 14-mg/kg/day dose.
The weight of the maternal liver (relative to body weight) was elevated above control values at all dose levels
The total number of implants per litter was unaltered by treatment with the exception of an apparently spurious reduction at 400 mg/kg/day - Ovaries and uterine content:
- Reproductive outcome in pregnant Long-Evans hooded rats following exposure to dichloroacetic acid on days 6-15 of gestation
Treatment
(mg/kg/day) Sperm positive females treated Deaths Pregnant Viable litters Body weight
D0 G±SD
D20 % Wt Gain
±SD Adjusted
% Wt Gain
±SD
H2O 19 00 19 19 226.7±18 343.0±27 51.5±8 21.0±6
DCA 14 19 00 18 18 223.7±22 348.5±30 49.7±12 20.3±6
DCA 140 20 00 19 19 228.3±22 337.2±31 48.0±8 16.2±5
DCA 400 19 00 19 19 227.7±17 326.8±28 43.6±8 13.3±5
Live fetuses showed dose-dependent reductions in weight and length at doses above 140 mgkg - Fetal examinations:
- Dose-related increases were seen in external, total soft tissue, cardiovascular, urogenital and orbital malformations.
- Statistics:
- Not Available
- Indices:
- Not Available
- Historical control data:
- Not Available
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Maternal livers, spleens and kidneys showed dose-related hypertrophy, and at all except the lowest dose (14 mg/kg/day) the adjusted percentage body weight gain in the dams was significantly reduced in comparison with the controls.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 14 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 14 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Remarks on result:
- other: not specified
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes. Remark: no dose-related trend in sex ratio alteration was seen at the 14 mg/kg/day
Details on embryotoxic / teratogenic effects:
no dose-related trend in sex ratio alteration was seen at the 14 mg/kg/day
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOEL
- Effect level:
- 140 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: embryotoxicity
- Remarks on result:
- other: not specified
- Dose descriptor:
- LOEL
- Effect level:
- 140 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: teratogenicity
- Remarks on result:
- other: not specified
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The Dichloroacetic acid treated on Long-Evans rat had shown NOAEL (no observed adverse effect level) for maternal and developmental toxicity in Long-Evans rats treated with dichloroacetic acid was found to be 14 mg/kg bw/day, while the LOEL (Low observed effect level) for embryotoxicity and teratogenicity was 140 mg/kg bw/day.
- Executive summary:
The developmental toxicity of DCA (Dichloroacetic acid) was assessed in a one generation study with pregnant Long-Evans rats at dose levels of 0, 14, 140 or 400 mg/kg/day. The rats were orally administrated with DCA in distilled water on gestation days 6-15. Maternal observations included clinical signs, weight change, and gross evaluation of organ weights and uterine contents at necropsy (day20).Corpora lutea were counted and uteri stained for implantation sites. Live fetuses were examined for external, skeletal, and soft tissue malformations.While in increased post-implantation resorptions at 900+ mg/kg bw per day, reduced fetal body weights at 400+ mg/kg bw per day, maternal toxicity at 14+ mg/kg bw per day malformations shown in cardiovascular at 400+ mg/kg bw per day soft tissue at 140+ mg/kg bw per day urogenital at 1400+ mg/kg bw per day. Liver, spleen, and kidney weights increased in a dose-related manner. The mean percentage of resorbed implants per litter was significantly elevated at 2900 mg/kg/day
The No observed adverse effect level (NOAEL)for maternal and developmental toxicity was found to be 14 mg/kg-bw/day, and the Low observed effect level (LOEL)for embryotoxicity and teratogenicitywas 140 mg/kg-bw/day.
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