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EC number: 206-117-5 | CAS number: 302-17-0
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / 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
- Justification for type of information:
- Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Preliminary screening for the potential of drinking water disinfection byproducts to alter male reproduction.
- Author:
- Gary R. Klinefelter’, Juan D. Suarez, Naomi L. Roberts, And Anthony B. Deangelo
- Year:
- 1 995
- Bibliographic source:
- Reproductive Toxicology, Vol. 9, No. 6. pp. 571-578, 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The reproductive effect of Chloral hydrate was evaluated in F344 male rats when administered orally in a one-generation.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2,2-trichloroethane-1-1-diol
- IUPAC Name:
- 2,2,2-trichloroethane-1-1-diol
- Reference substance name:
- 2,2,2-trichloroethane-1,1-diol
- EC Number:
- 206-117-5
- EC Name:
- 2,2,2-trichloroethane-1,1-diol
- Cas Number:
- 302-17-0
- Molecular formula:
- C2H3Cl3O2
- IUPAC Name:
- 2,2,2-trichloroethane-1,1-diol
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Chloral Hydrate
- Molecular formula (if other than submission substance): C2 H3C13O2
- Molecular weight (if other than submission substance): 165.403 g/mol
- Smiles notation (if other than submission substance):C(C(O)O)(Cl)(Cl)Cl
- InChl (if other than submission substance):1S/C2H3Cl3O2/c3-2(4,5)1(6)7/h1,6-7H
- Substance type: Organic
- Physical state: crystalline
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Laboratories (Portage, MI)
- Age at study initiation: (P) x wks= 28 days of age
-Weight at study initiation: (P) Males: No data available
- Fasting period before study: No data available
- Housing: Animals were housed two per cage (20 x 25 x 47 cm) with laboratory grade pine shavings as bedding.
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet (e.g. ad libitum): Purina Laboratory Chow ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%):40 to 60%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 Light : 12 Dark, lights out at 1900 h
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Deionized water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose were Prepared by dissolving 0.5 g/L CH, and 2.0 g/L Chloral hydrate (CH) in deionized water which is equivalent to 55.0 and 188.0 mg/kg.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): vehicle used was deionized water
- Concentration in vehicle: 0.5 g/L and 2.0 g/L (i.e 55 mg/kg and 188 mg/kg resptively)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - Any other deviations from standard protocol: Only male reproductive function was analysis in this study.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of the bottled drinking water solutions were analyzed GC analysis monthly.
Analyses revealed that average actual concentrations were 0.78 g/L and 2.7 g/L for the CH exposures. - Duration of treatment / exposure:
- 52 week
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 55 and 188 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- Total: 18
0 mg/kg/day: 6 male
55.0 mg/kg/day: 6 male
188.0 mg/kg/day: 6 male - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data available
- Rationale for animal assignment (if not random): random
- Other: The rats used in this study were part of two different chronic cancer bioassay studies that were initiated in consecutive years. The sperm samples collected from each study were obtained at an interim (52 week) necropsy.
Water consumption and body weights were recorded weekly during the first month of exposure and then monthly afterward.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No
- Time schedule: No data available
BODY WEIGHT: Yes
- Time schedule for examinations: weekly for first month and then monthly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly for first month and then monthly
OTHER: At necropsy, the body, kidney, liver, spleen, and thyroid were weighed. all organs were examined for gross lesions, including discolorations, surface irregularities, nodular changes, and tumor masses. The left testis and epididymis were removed along with the liver, spleen, kidney, thyroid, stomach, intestine, and bladder for routine histopathologic analysis.
Computer-assisted motion analysis of cauda epididymal sperm, together with testicular and epididymal histopathology, as a preliminary screening for the potential of chloral hydrate to alter male reproductive function was performed. - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- Percentage of motile sperm, percentage of progressively motile sperm, epididymal sperm motion and straight-line velocity, average path velocity and curvilinear velocity of sperm were examined.
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Organ weight, Gross abnormalities and histopathology of male rat were examined
Organ weighted: Kidney, liver, spleen and thyroid gland
Organ examined:
Discolorations, surface irregularities, nodular changes and tumor masses. The left testis and epididymis, liver, spleen, kidney, thyroid, stomach, intestine and urinary bladder were examined - Postmortem examinations (offspring):
- No data available
- Statistics:
- Statistical analysis were performed by using General Linear Model for motility parameters; percent motile, percent progressively motile, straight-line velocity, curvilinear velocity, path velocity, and linear index.
When significant differences (P < 0.05) were found in the overall ANOVA, the least-square means were compared to determine differences between the vehicle and CH-treatment groups.
An ANOVA also was used to analyze the number of sperm with a straight-line velocity less than 60 pm/s in the vehicle and 188 mgikg CH groups to determine significant treatment effects. The analysis was adjusted for differences in the number of motile sperm per treatment group. - Reproductive indices:
- Linear index of sperm were examined.
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- not specified
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS):No significantly different were observed in body weight of treated rat as compared to control.
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS):From water comsumption 55 mg/kg and 188 mg/kg of dose for Chloral hydrate CH were determine.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS):No data available
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS):When treated with 188.0 mg/kg/day significant decreased were observed in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT) were observed.
Mean straight-line velocities average path and straight-line velocity distributions were shifted to a lower modal velocity range as compared to control in 188 mg/kg/day .
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):No data available
ORGAN WEIGHTS (PARENTAL ANIMALS):No significant change were observed in organ weight of treated rat as compared to control.
GROSS PATHOLOGY (PARENTAL ANIMALS):No gross lesions were observed in treated rat as copmared to control.
HISTOPATHOLOGY (PARENTAL ANIMALS):No evidences of perturbations in testicular histology such as seminiferous tubule atrophy, sloughed germ cells, or the presence of residual bodies in the lumen of the seminiferous tubule and no testicular or epididymal cells were observed in the lumen of the epididymis and there was no indication of an inflammatory response or granuloma formation were observed in treated rat as comapred to control.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 55 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive function (sperm measures)
- Dose descriptor:
- LOAEL
- Effect level:
- 188 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- reproductive function (sperm measures)
Target system / organ toxicity (P0)
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Histopathological findings:
- not specified
Details on results (F1)
Effect levels (F1)
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 55.0 mg/kg bw/day while LOAEL was determined to be 188.0 mg/kg/day on the basis of effects in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT) when F344 male rats were exposed to chloral hydrate for 52 weeks.
- Executive summary:
In a reproductive toxicity study, F344 male rat were exposed to chloral hydratein the concentration of 0, 55.0 and 188.0 mg/kg/day by oral drinking water for 52 weeks.
No significant effect were observed on clinical sign, body weight, organ weight, gross pathology and histopathology but significant decrease were observed in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT). In addition, Mean straight-line velocities average path and straight-line velocity distributions were shifted to a lower modal velocity range in 188.0 mg/kg/day treated rat as compared to control.
Therefore, NOAEL was considered to be 55.0 mg/kg bw/day while LOAEL was determined to be 188.0 mg/kg/day on the basis of effects in percentage of motile sperm (MOT) and percentage of progressively motile sperm (PMOT) when F344 male rats were exposed to chloral hydrate for 52 weeks.
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