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EC number: 200-911-5 | CAS number: 75-87-6
- 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:
- fertility, other
- Remarks:
- Cardiac teratogenesis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal.
Data source
Reference
- Reference Type:
- publication
- Title:
- A Review: Trichloroethylene Metabolites: Potential Cardiac Teratogens
- Author:
- Paula D. Johnson, Brenda V. Dawson and Stanley J. Goldberg
- Year:
- 1 998
- Bibliographic source:
- Environmental Health Perspectives, Vol 106, Supplement 4, 995-999, August 1998.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Reproductive toxicity effect of test chemical was evaluated by conducting experiment on rat.
- GLP compliance:
- no
- Limit test:
- no
- Justification for study design:
- No data
Test material
- Reference substance name:
- Trichloroacetaldehyde
- EC Number:
- 200-911-5
- EC Name:
- Trichloroacetaldehyde
- Cas Number:
- 75-87-6
- Molecular formula:
- C2HCl3O
- IUPAC Name:
- 2,2,2-trichloroacetaldehyde
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Chloral
- Molecular formula: C2HCl3O
- Molecular weight: 147.3879 g/mol
- Substance type: organic
- Physical state: Liquid
- Smiles notation: C(C=O)(Cl)(Cl)Cl
- InChl: 1S/C2HCl3O/c3-2(4,5)1-6/h1H
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Remarks:
- drinking
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test chemical was dissolve in drinking Water.
VEHICLE
- Justification for use and choice of vehicle (if other than water): drinking water
- Concentration in vehicle: 0 and 151 mg/kg bw
- Amount of vehicle (if gavage): 42 ml/day
- Lot/batch no. (if required): No data
- Purity: No data - Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- approx 21 days (During pregnancy)
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrations
- Remarks:
- 0 and 151 mg/kg bw/day
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included: Rats were observed for mortality.
DETAILED CLINICAL OBSERVATIONS: Rats were observed for sign of toxicity.
- Time schedule: No data
BODY WEIGHT: Rats were observed for body weight.
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OTHER: - Oestrous cyclicity (parental animals):
- Pregnancy complications, implantation sites, were observed
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Numbers of live or dead fetuses, fetal weight and crown-rump length were observed
- Postmortem examinations (parental animals):
- uterine and ovarian morphologic were examinations.
- Postmortem examinations (offspring):
- placental weight, no gross external or noncardiac internal organ congenital abnormalitieswere examined.
- Statistics:
- Using Fisher exact analysis, mean number of implantation site and resorption site for treated group and control group was estimated.
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No evidence of toxicity was observed in treated female rats at 151 mg/kg bw as compared to contorl.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed in treated female rats at 151 mg/kg bw as compared to contorl.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No change in body weight gain was observed in treated female rats at 151 mg/kg bw as compared to contorl.
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect on implantation sites and resorption sites were observed in treated female rats at 151 mg/kg bw as compared to contorl.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on live and dead fetuses were observed in treated female rats at 151 mg/kg bw as compared to contorl.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 151 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effects were noted
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: Not specified
- Organ:
- not specified
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (P1)
- Critical effects observed:
- not specified
- System:
- other: Not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No efect on numbers of live or dead fetuses were observed.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on fetal weight were observed.
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No effect on placental weight were observed.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No effect on external morphology were observed.
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effect on crown-rump length and noncardiac internal organ congenital abnormalities were observed.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 151 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- organ weights and organ / body weight ratios
- gross pathology
- other: cardiac defects
Target system / organ toxicity (F1)
- Critical effects observed:
- no
- System:
- cardiovascular
- Organ:
- heart
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F2)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- other: not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Any other information on results incl. tables
Table: Congenital cardiac Malformations
|
Group |
Heart abnormalities |
Trichloroacetaldehyde p. (151 mg/kg bw/day) |
Abnormal looping |
- |
Aortic hypoplasia |
- |
Pulmonary artery hypoplasia |
- |
Atrial septal defects |
2 |
Mitral valve defects, Hypoplasia or ectasia |
2 |
Tricuspid valve defects, Hypoplasia or ectasia |
- |
Ventricular septal defects, Perimembranousa Mascular |
3 - |
Atrioventricular Septal defects |
- |
Pulmonary valve defects |
1 |
Aortic valve defects |
- |
Situs inversus |
- |
Total Abnormal Hearts Fetuses with abnormal hearts Fetuses |
8 8 248 |
aSubaortic
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 151 mg/kg/day for P and F1 generation when female rats were treated with test chemical orally in water.
- Executive summary:
The reproductive toxicity of test chemical was evaluated by conducting experiment in female rats. Test chemical was administered orally in drinking water. Chemical was given to rats during organogenesis at the concentration of 0 and 151 mg/kg bw/day. No reproductive effects were observed on health, weight gain, and pregnancy, uterine and ovarian morphologic examinations. Similarly, no effect on implantation sites, resorption sites were observed as compared to control. In addition, no developmental effect such as live and dead fetuses, fetal weight, placental weight, crown-rump length, gross external or no cardiac internal organ congenital abnormalities were observed in fetus of treated female rats. Therefore, NOAEL was considered to be 151 mg/kg/day P and F1 generation when female rats were treated with test chemical orally in water.
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