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EC number: 807-534-0 | CAS number: 1228284-89-6
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-01-21 until 2014-02-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was carried out following OECD guideline 425 and in compliance with GLP. The method description is well documented. Statistical treatment of results, clinical signs and mortality were reported.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- up-and-down procedure
- Limit test:
- no
Test material
- Reference substance name:
- 1-(2,4,6-trichlorophenyl)acetone O-methyloxime
- EC Number:
- 807-534-0
- Cas Number:
- 1228284-89-6
- Molecular formula:
- C10H10Cl3NO
- IUPAC Name:
- 1-(2,4,6-trichlorophenyl)acetone O-methyloxime
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: Brown liquid
- Purity test date: 25 September 2013
- Expiration date of the lot/batch: End September 2015
- Stability under test conditions: Stable until end September 2015
- Storage condition of test material: Room temperature (<30°C), protected from light and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories S.r.l., S.Pietro al Natisone (UD), Zona Industriale Azzida, 57, 33040, Italy
- Strain: RccHan:WIST
- Age at study initiation: 8-11 weeks
- Weight at study initiation: 166-187 g
- Fasting period before study: Yes (overnight)
- Housing: Individually in Type II. polypropylene/polycarbonate cages
- Diet: Ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" ad libitum (except for overnight pre-dose fast and for 3 hours post dose). Ssniff Spezialdiäten GmbH, D-59494 Soest Germany
- Water: Municipal tap water ad libitum
- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3-23.9
- Humidity (%): 34-62
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 January 2014 To: 25 February 2014
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE: Corn oil
DOSAGE PREPARATION: Test item was melted in a water bath at a temperature not exceeding 50°C prior to formulating with corn oil.
DOSE VOLUME: 10 mL/kg body weight - Doses:
- 2000 and 550 mg/kg bw
- No. of animals per sex per dose:
- 2 females at 550 mg/kg bw, 5 females at 2000 mg/kg bw
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed individually after dosing at 30 minutes, 1, 2, 3, 4, and 6 hours and once each day for 14 days thereafter. Body weights were recorded on Days -1 (prior to the removal of food), 0 (prior to administration), 7 and 14.
- Necropsy of survivors performed: Yes - Statistics:
- As the AOT425StatPgm program could not estimate an exact LD50 in this case, due to the pattern of mortality. In line with the OECD guideline, an alternative calculation method was used. Probit analysis was performed, within the SPSS PC+4.0 package. This is the standard validated statistical software package used at this facility for Probit analysis on acute studies for LD50 and LC50 calculations.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 830 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no mortalities at 550 mg/kg. Mortality was observed in one animal (1/5) dosed at 2000 mg/kg bw on Day 2.
- Clinical signs:
- At 550 mg/kg, the following were seen: decreased activity (1/2), hunched back (1/2) and piloerection (1/2). All animals were symptom free from 1 day after the treatment.
At 2000 mg/kg, the following were seen: decreased activity (5/5), hunched back (5/5), prone position (5/5), incoordination (5/5), piloerection (3/5) and irritability (4/5). All surviving animals were symptom free from Day 4 after treatment. - Body weight:
- There were no treatment related body weight changes.
- Gross pathology:
- There was no treatment related macroscopic findings in surviving animals. In the 2000 mg/kg animal that was found dead, the following findings were recorded in the lungs: collapsed; dark discoloration, red, diffuse all lobes; foamy material, white.
Any other information on results incl. tables
Table 1: Acute oral toxicity in the rat (mortality data)
Animal number |
Dose (mg/kg bw) |
Volume dosed (mL) |
Mortality |
5101 |
550 |
1.7 |
Survived |
5102 |
2000 |
1.7 |
Survived |
5103 |
2000 |
1.8 |
Survived |
5104 |
2000 |
1.9 |
Died (Day 2) |
5105 |
550 |
1.8 |
Survived |
5106 |
2000 |
1.9 |
Survived |
5089 |
2000 |
1.9 |
Survived |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the acute oral median lethal dose LD50 of the test item was greater than 2000 mg/kg bw in RccHan:WIST female rats. The value for the LD50 calculated by Probit analysis is 2830 mg/kg bw (confidence limits could not be calculated).
- Executive summary:
An acute oral toxicity (up and down procedure) study was conducted with 7 animals (female RccHan:WIST rats). Animals were treated with a single oral (gavage) dose of the test item at a dose level of 550 (2 animals) or 2000 (5 animals) mg/kg body weight (bw) followed by a 14 day observation period. The animals were fasted overnight prior to treatment and food was returned 3 hours after dosing. All animals were observed individually after dosing at 30 minutes, 1, 2, 3, 4 and 6 hours post treatment and once each day for 14 days thereafter. Body weight was measured on Day -1 (prior to removal of food), Day 0 (prior to administration) and weekly thereafter. All animals were examined macroscopically at the end of the study.
No mortality was observed at the dose level of 550 mg/kg bw. Treatment at 550 mg/kg bw caused decreased activity (1/2), hunched back (1/2) and piloerection (1/2). All animals were symptom free from 1 day after the treatment. Mortality was observed in one animal (1/5) on Day 2 at 2000 mg/kg bw dose level. Treatment at 2000 mg/kg bw caused decreased activity (5/5), hunched back (5/5), prone position (5/5), incoordination (5/5), piloerection (3/5) and irritability (4/5). All surviving animals were symptom free from Day 4 after treatment. 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 test item-related observations at the dose level of 550 mg/kg bw at necropsy.
Under the conditions of this study, the acute oral median lethal dose LD50 of the test item was greater than 2000 mg/kg bw in RccHan:WIST female rats. The value for the LD50 calculated by Probit analysis is 2830 mg/kg bw (confidence limits could not be calculated).
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