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EC number: 204-310-9 | CAS number: 119-27-7
- 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:
- 26 May - 17 December, 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 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- not applicable
- Remarks:
- Due to the short term nature of the study, no analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation. This exception is considered not to affec the integrity or validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- not applicable
- Remarks:
- Due to the short term nature of the study, no analysis was carried out to determine the homogeneity, concentration or stability of the test item formulation. This exception is considered not to affec the integrity or validity of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- 2,4-dinitroanisole
- EC Number:
- 204-310-9
- EC Name:
- 2,4-dinitroanisole
- Cas Number:
- 119-27-7
- Molecular formula:
- C7H6N2O5
- IUPAC Name:
- 2,4-dinitroanisole
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Physical state/Apparence : pale yellow powder
- Source and lot/batch No.of test material: 55503625
- Expiration date of the lot/batch: 28 April 2019
- Purity test date: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature in the dark
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was prepared as a suspension in arachis oil BP.
The arachid oil BP was used because the test item dod not dissolve/suspend in distilled water.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan : WIST
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Females nulliparous and non-pregnant
- Age at study initiation: 8-12 weeks of age
- Fasting period before study: an overnight before dosing and for approximately 3 to 4 hours after dosing
- Housing: animal were foused in groups of up to four in suspended solid-floor polypropylene cages surnished with woodflakes
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: 5 days
- Body Weight: the body weight variation did not exceed +/- 20% of the mean body weight at the stard of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/ 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Using available information on the toxicity ot the test item, 50 mg/kg was chosen as the starting dose
A single animal was treated with 50mg/kg.
In the absence of mortality at this dose level, an additional animal was treated with 300 mg/kg.
In the absence of mortality at this dose level, an additional animal was treated with 2000 mg/kg.
Due to mortality at the dose level of 2000 mg/kg, an additional group of 4 animals was treated at 300 mg/kg. - Doses:
- 50, 300, 2000 mg/kg
- No. of animals per sex per dose:
- 1 animal for 50 mg/kg and 2000 mg/kg
5 animal for 300 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of clinical observation period following administration: 30 min, 1, 2 and 4 hours after dosing and the daily for up to 14 days.
- Frequency of weighing: day 0 and on day 7 and 14 or at death.
- Frequanecy of morbidity and mortality : twice daily, early and late during normal working day, and once daily at weekends and public holidays.
- Euthanasia : animals were killed by cervical dislocation
- Necropsy of survivors performed: yes for all animals
Evaluation of data included identification of the number of animals that died during the study (or that were killed for humane reasons), and determination of the nature, severity, onset and duration of the toxic effects. If possible, the signs of evident toxicity were described.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 50 mg/kg: no mortalilty
At 300 mg/kg: no mortality
At 2000 mg/kg: the animal was killed for humane reasons, 2 hours after dosing, due to the occurence of clinical signs of toxicity that approached the severity
limit set forth in th UK Home Office Project License. - Clinical signs:
- other: At 50 mg/kg: Hunched posture and ataxia were noted during the day of dosing. The animal appeared normal 1 day after dosing. At 300 mg/kg: No signs of systemic toxicity during the observation period. At 2000 mg/kg: Signs of systemic toxicity noted were
- Gross pathology:
- At 50 mg/kg and 300 mg/kg: No abnormalities were noted at necropsy.
At 2000 mg/kg: Abnormalities noted at necropsy were patchy pallor of the liver, dark kidneys and clear liquid present in the stomach. - Other findings:
- NA
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
An acute oral toxicity in the Wistar strain rat (A. Sanders, 2017, Envigo) has been performed, according the 420 OECD guideline in order to assess the LD50 of the test item.
Following a sighthing test at dose levels of 50, 300 and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 300 mg/kg. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
At 2000 mg/kg, animal was killed because of evident sign of systemic toxicity, confirmed by necropsy.
At 50 and 300 mg/kg, no mortality, no sign of systemic toxicity (also in necropsy) were observed.
Therefore the LD50 ot the test item in the female Wistar strain rat is estimated to be in the range of 300 -2000 mg/kg.
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