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EC number: 218-780-8 | CAS number: 2234-16-4
- 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
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- Endpoint summary
- Stability
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 September 2017 - 27 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-(2,4-dichlorophenyl)ethan-1-one
- EC Number:
- 218-780-8
- EC Name:
- 1-(2,4-dichlorophenyl)ethan-1-one
- Cas Number:
- 2234-16-4
- Molecular formula:
- C8H6Cl2O
- IUPAC Name:
- 1-(2,4-dichlorophenyl)ethan-1-one
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 weeks old
- Weight at study initiation: 211 - 260 g
- Fasting period before study: On the night before treatment, the animals were fasted. The food was returned 3 hours after the treatment.
- Housing: 3 animals/cage (Type II. polypropylene/polycarbonate cages).
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 26 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2 – 25.0 °C
- Humidity (%): 34 – 80 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m..
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The selection of the vehicle was made during trial formulation with the test item. In order of preference, recommended vehicles were: distilled water, 0.5 or 1% methyl cellulose or carboxymethylcellulose, PEG 400, oil (corn or sunflower) and DMSO. The formulations prepared with distilled water or with 1% methyl cellulose (with continuous magnetic stirring) resulted inhomogeneous formats. Using PEG 400, a homogeneous format was available, which was suitable for oral gavage of the rats.
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual): The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0), weekly thereafter (Day 7) and at necropsy (Day 14).
- Necropsy of survivors performed: yes
Macroscopic examination was performed on all animals. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Test item did not cause mortality at a dose level of 2000 mg/kg bw in any animal.
- Clinical signs:
- other: At the dose level of 2000 mg/kg bw, the following symptoms were observed up to Day 1: slightly or/to moderately or/to markedly decreased activity (6 out of 6 animals), hunched back (6 out of 6 animals), slight and/or moderate incoordination (6 out of 6 an
- Gross pathology:
- There was no evidence of the macroscopic changes at necropsy at a dose level of 2000 mg/kg bw in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
- Executive summary:
An acute oral toxicity test was performed according to OECD Guideline 423 and EU Method B.1.tris (GLP study). Two groups of three female Crl:WI rats were treated with the test itemat a dose level of 2000 mg/kg body weight (bw) (Group 1 and Group 2). The test item was administered by gavage at the dose level of 2000 mg/kg bw. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group. The following symptoms were observed up to Day 1: slightly or/to moderately or/to markedly decreased activity (6 out of 6 animals), hunched back (6 out of 6 animals), slight and/or moderate incoordination (6 out of 6 animals), piloerection (4 out of 6 animals) and prone position (2 out of 6 animals). From Day 2, all animals were symptom-free until the end of the observation period. There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age. There was no evidence of the macroscopic changes at necropsy at a dose level of 2000 mg/kg bw. Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
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