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EC number: 479-390-3 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 479-390-3
- EC Name:
- -
- Cas Number:
- 42252-34-6
- Molecular formula:
- C4H8ClNO
- IUPAC Name:
- N-ethyl-N-methylcarbamoyl chloride
- Test material form:
- liquid
- Remarks:
- colourless.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): EMCA
- Physical state: Colourless liquid
- Analytical purity: 99.3 %
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deuthschland, Sulzfeld, Germany.
- Age at study initiation: Eight to twelve weeks old.
- Weight at study initiation: Body weight did not exceed ± 20 %.
- Fasting period before study: Yes, overnight for a maximum of 20 hours.
- Housing: Three animals per cage in labelled Macrolon cages containing sterilised sawdust as beeding material and paper as cage enrichment.
- Diet : ad libitum to pelleted rodent dient.
- Water (e.g. ad libitum): Tap water ad libitum-
- Acclimation period: 5 days.
- Other: Females nilliparous and non-pregnant females were selected.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 - 21.7 ºC
- Humidity (%): 36-80 %
- Air changes (per hr): 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 0.27 mL/kg bw (300 mg/kg bw dose) and 1.80 mL/kg-bw (2000 mg/kg bw dose).
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: When there is no information on a substance to be tested, for animal welfare reasons it is recommended to use the starting dose of 300 mg/kg
body weight. Therefore, this was chosen as the starting dose.
The toxicity of the substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose lvel of 300 mg/kg-bw. The absence of presence of mortality of animals dosed at one step determined the next step. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups. - Doses:
- 300 and 2000 mg/kg-bw
- No. of animals per sex per dose:
- 6 females for the 300 mg/kg-bw dose and 3 females for the 2000 mg/kg-bw dose.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality and viability were determined twice daily, the time of death was recorded as precisely as possible, weight was determined on day 1 (pre-administration), 8 and 15, clinical signs were periodically registered on day 1 and once daily thereafter until day 15.
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: cut-off value.
- Mortality:
- Two females treated at 2000 mg/kg-bw were found on day 1. No further mortality occured at 2000 and 300 mg/kg-bw
- Clinical signs:
- 300 mg/kg-bw: Hunched posture, uncoordinated movements, piloerection
2000 mg/kg-bw (surviving animal): Hunched posture, piloerection
2000 mg/kg-bw (animals found dead): Lethargy, flat/cramped posture, slow breathing, piloerection, watery discharge from both eyes, hyperthermia.
The surviving animals had recovered from clinical signs by day 2. - Body weight:
- The mean body weight gain shown by surviving animals was considered to be similar to that expected of normal untreated animals of the same age and strain.
- Gross pathology:
- Many dark red foci in the glandular mucosa of the stomach were found in one animal that died during experiment. Macroscopic examination of the other animal that died during the experiment and surviving animals did not reveal any abnormalities.
Any other information on results incl. tables
Table 1. Summary of results.
Step |
No. of animals |
Dose (mg/kg bw) |
Mortality |
Interpretation |
LD50cut-off (mg/kg bw) |
1 |
3 |
300 |
0 |
Category 4. > 300 – 2000 mg/kg bw |
1000 |
2 |
3 |
300 |
0 |
||
3 |
3 |
2000 |
2 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- EU criteria.
- Conclusions:
- The oral-LD50 value for the test subtance in Wistar rats was between 300 and 2000 mg/kg-bw. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg bw.
- Executive summary:
An acute oral toxicity study was performed according to OECD 423 with the test item under GLP conditions. Initially a group of 3 female rats was exposed to the test item by a single oral dose by gavage at 300 mg/ kg body weight. In a stepwise procedure, additional groups of female rats were dosed at 300 and 2000 mg/kg-bw. All animals were subject to daily observations and weekly determinations of bodyweight. Macroscopic examination was performed on the day of the death or after terminal sacrifice at day 15 . Two deaths occured on day 1 in the group of the highest dose level, no further mortality occurred. Clinical signs observed in death animals included lethargy, flat/cramped posture, slow breathing, piloerection, watery discharge from both eyes and hyperthermia, while clinical signs of the animals that survived the experiment included hunched posture, uncoordinated movements and piloerection.
The surviving animals had recovered from the symptoms on day 2. Based on the results the oral LD50 for the test substance in rat is between 300 and 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 1000 mg/kg bw.
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