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EC number: 930-964-6 | CAS number: -
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): chloressigsäuremethylester
- Physical state: colourless liquid
- Analytical purity: 99%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Pharma-Forschung-Toxikologie, Kastengrund
- Age at study initiation: 45 days
- Weight at study initiation: males: 147-161 g; females: 144-158 g
- Diet (e.g. ad libitum): Altromin R1324 - Pellets (Altromin GmbH, Lage/Lippe), ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 50 ± 20%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The substance was applied continuously with a evaporator at 130 ºC. The preparation-air mixture was led by an air current of 800 l/h by a tube administration in the inhalation chamber. To reach the wished concentration as quickly as possible, the preparation was brought in two phases in the chamber.
TEST ATMOSPHERE
- Brief description of analytical method used: single-beam photometer
- Samples taken from breathing zone: yes
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 5 days per week (20 treatments), 6 hours daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 33, 100 ppm (0, 0.04, 0.14, 0.45 mg/l)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Post-exposure recovery period in satellite groups: five animals per sex per dose were necropsied on day 1 after the 28-day exposure and five animals per sex per dose were necropsied on day 14 after the 28-day exposure.
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: The behaviour and the general state of health of the animals were judged in each case once before the exposition beginning and after the exposition end as well as continuously during the exposition. Once at weekends as well as during the recovery periode the animals were examined daily.
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION: Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
- Time schedule for collection of blood: two groups of animals: day 1 after the 28-day exposure and day 14 after the 28-day exposure
- How many animals: Group 1: 5 animals per sex per dose; Group 2: 5 animals per sex per dose
- Parameters: erythrocyte count, haemoglobin, haematocrit, total and differential leucocyte count, platelet count, reticulocyte count (only for control and highest concentration groups), coagulation, thromboplastin time and partial thromboplastine time.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: two groups of animals: day 1 after the 28-day exposure and day 14 after the 28-day exposure
- How many animals: Group 1: 5 animals per sex per dose; Group 2: 5 animals per sex per dose
- Parameters: sodium, potassium, phosphorus, bilirubin, total bilirubin, creatinine, glucose, urea nitrogen, calcium, chloride, glutamic-pyruvic transaminase, glutamic-oxaloacetic transaminase, alkaline phosphatase, gamma glutamyl transpeptidase, cholesterol, triglycerides, total lipids, albumin, globulin and methaemoglobin.
URINALYSIS: Yes
- Time schedule for collection of blood: two groups of animals: day 1 after the 28-day exposure and day 14 after the 28-day exposure
- How many animals: Group 1: 5 animals per sex per dose; Group 2: 5 animals per sex per dose
- Parameters: appearance, colour, glucose, haemoglobin, bilirubin, pH and sediment.
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: weekly - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Organ weights: absolute and relative weights of the following organs: heart, lungs, liver, kidneys, spleen, testicles, ovaries, adrenal glands, thyroid, brain.
- Statistics:
- The evaluation was executed using a program package for the evaluation of toxicological studies (Standard Operating Procedure von Dr. Passing, Abt. fur praktische Mathematik, durch Abt. Pharma Forschung Dokumentation).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 33 ppm
- Sex:
- female
- Basis for effect level:
- other: see 'Remark'
- Dose descriptor:
- NOEL
- Effect level:
- 10 ppm
- Sex:
- male
- Basis for effect level:
- other: At 33 ppm: clinical signs such as narrowed eye lids, increased tendency to clean themselves, sneezing, retardation of the body weight development, reduced food consumption.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Applicant's summary and conclusion
- Conclusions:
- Based on the effects observed in a 28-day subacute inhalation study, the NOEL was 33 ppm for females and 10 ppm for males.
- Executive summary:
A subacute inhalation study was carried out with the substance Methyl chloroacetate in Wistar rats. Ten animals per sex per group received 5 treatments per week during 28 days. The duration of each treatment was 6 hours and the following concentrations were used: 0, 10, 33 and 100 ppm. Five animals per sex per dose were necropsied on day 1 after the 28-day exposure. A satellite groups of five animals per sex per dose was maintained during a post-exposure period of 14 days. The following examinations were conducted: clinical signs, mortality, body weight, food consumption and food efficiency, water consumption, ophthalmoscopic examination, haematology, clinical chemistry, urinalysis, neurobehavioural examination, gross pathology, histopathology and organ weights. Based on the effects observed, such as clinical signs, retardation of the body weight development or changes in lung weight with no evidence of organ dysfunction, the NOEL was 33 ppm for females and 10 ppm for males.
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