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EC number: 210-695-4 | CAS number: 621-62-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Ethane, 2-Chloro-1,1-Dimethoxy-
- IUPAC Name:
- Ethane, 2-Chloro-1,1-Dimethoxy-
- Reference substance name:
- 97-97-02
- IUPAC Name:
- 97-97-02
- Reference substance name:
- 2-chloro-1,1-dimethoxyethane
- EC Number:
- 202-624-0
- EC Name:
- 2-chloro-1,1-dimethoxyethane
- Cas Number:
- 97-97-2
- Molecular formula:
- C4H9ClO2
- IUPAC Name:
- 2-chloro-1,1-dimethoxyethane
- Test material form:
- other: colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): Chloroacetaldehyde dimethylacetal
- Physical state: colourless liquid
- Storage condition of test material: room temperature
- Container: brown glass bottle x2
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (U.K.) Limited, Manston, Kent
- Age at study initiation: 5-6 weeks
- Weight at study initiation: males: 137-168g, females: 127-159g
- Housing: polypropylene grid-floor cages suspended over trays lined with absorbent paper
- Diet: free access to food except during urine collection when food was withdrawn overnight
- Water: free access
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 37-68%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (control), 15.3, 51, 204, 0 (satellite), 204 (satellite) mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: immediately before dosing and one and five hours after dosing during working week; immediately before dosing and one hours after dosing at weekends and public holidays; twice daily, morning and afternoon during treatment free period (one daily at weekends).
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 7, 14, 21, 28
FOOD&WATER CONSUMPTION: Yes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of study (day 28)
- Anaesthetic used for blood collection: Yes: Clotting time was assessed by "Hepato Quick" time using samples collected into sodium citrate solution (0.11 mol/L)
- Animals fasted: Yes
- How many animals: all from groups 1-4
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of study (day 28)
- Animals fasted: No
- How many animals: all of groups 1-4
URINALYSIS: Yes
- Time schedule for collection of urine: collected over a period of approx. 16h
- Parameters were examined:Volume, Specific gravity, pH, Protein, Glucose, Ketones, Bilirubin, Urobilinogen, Reducing substances, Blood
- animals: all
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes but normal hydration - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in kidney weights, liver weights
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- changes in kidneys, not relevant for humans
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- The administration of CADMA by oral gavage for a period of twenty-eight con-secutive days resulted in toxicologically significant changes at dose levels of 50 and 200 mg/kg/day. Increases in plasma alkaline phosphatase and bilirubin were apparent, although statistical significance was not achieved, possibly suggesting a slight liver change. This was supported by increases in liver weight in both sexes, however there were no histopathological changes. Kidney weights were also ele-vated in animals of both sexes treated with 200 mg/kg/day. Microscopic examina-tion of kidney sections revealed intracytoplasmic hyaline droplet formation in the proximaltubular epithelium of male rats treated with 50 and 200 mg/kg/day. These changes resemble a well documented (Alden C.L. (1986). A Review of Unique Male Rat Hydrocarbon Nephropathy. Toxicologic Pathology 14.1. pp. 109-111) hydrocarbon nephropathy which occurs in male rats but not in other species. This effect is therefore not indicative of a hazard to human health. Nevertheless, statisti-cally significant increases in kidney weight were also detected in females treated with 200 mg/kg/day and it is therefore possible that another slight renal change was also present in high dose animals.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Organ weights, clinical chemistry
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Oral administration of the test material Chloroacetaldehyde dimethylacetal, to rats for a period of 28 consecutive days at dose levels of up to 200 mg/kg/day resulted in toxicologically significant changes at 50 and 200 mg/kg/day.
The NOEL is, therefore, considered to be 15 mg/kg/day. However, the changes at 50 mg/kg/day were confined to a kidney effect resembling hydrocarbon nephropathy which only occurs in male rats and is, therefore, not indicative of a hazard to human health. - Executive summary:
The test material Chloroacetaldehyde dimethylacetal was administered by gavage to three groups, each of five male and five female Sprague-Dawley CD strain rats, for 28 consecutive days, at dose levels of 15, 50 and 200 mg/kg/day (incorporating a correction factors to allow for 98% purity) comparable to the OECD Guideline Study 407. A control group of five males and five females was dosed with vehicle alone (arachis oil B.P.). Two satellite groups, each of five males and five females were treated with the high dose (200 mg/kg/day) or the vehicle alone throughout the 28 day study period and then maintained without treatment for a further 14 days.
Clinical signs, bodyweights, food and water consumptions were monitored during the study. Haematology, blood chemistry and urinalysis were evaluated for all main group animals during the final week of dosing. Parameters showing possible abnormalities were examined in satellite group animals at the end of the treatment-free period. All animals were subjected to a gross necropsy examination with histopathological evaluation of selected tissues.
Oral administration of the test material Chloroacetaldehyde dimethylacetal, to rats for a period of 28 consecutive days at dose levels of up to 200 mg/kg/day resulted in toxicologically significant changes at 50 and 200 mg/kg/day.
The NOEL is, therefore, considered to be 15 mg/kg/day. However, the changes at 50 mg/kg/day were confined to a kidney effect resembling hydrocarbon nephropathy which only occurs in male rats and is, therefore, not indicative of a hazard to human health.. The NOAEL therefore is 50 mg/kg bw.
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