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EC number: 431-060-1 | CAS number: 153719-38-1
- 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:
- 1995-09-06 until 1995-10-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 431-060-1
- EC Name:
- -
- Cas Number:
- 153719-38-1
- Molecular formula:
- Hill formula: C4H8N4O3 CAS formula: C4H8N4O3
- IUPAC Name:
- 3-methyl-N-nitro-3,6-dihydro-2H-1,3,5-oxadiazin-4-amine
- Details on test material:
- - Name of test material (as cited in study report): CA 2343 A (Intermediate of CGA 293343)
- Substance type: monoconstituent organic substance
- Physical state: solid
- Analytical purity: 96.7 %
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: P.503005
- Expiration date of the lot/batch: Date of reanalysis: December 1996
- Stability under test conditions: not reported
- Storage condition of test material: 0 - 5 °C
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino rats (Tif: RAI f (SPF))
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein / Switzerland
- Age at study initiation: "young adult rats", acc. to the study report
- Weight at study initiation: 174 to 217 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding
- Diet (e.g. ad libitum): Rat diet (NAFAG 890, NAFAG, Gossau/SG, Switzerland) ad libitum.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Rats were acclimatized at least for 5 days before administration.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle
IN-LIFE DATES: From: 1995-09-12 To: 1995-10-04
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: no justification given
- Lot/batch no. (if required): not reported
- Purity: not reported
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not applicable - Doses:
- 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations for mortality, weighing immediately before administration and on days 7 and 14
- Necropsy of survivors performed: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: clinical signs, body weight: daily for 14 days - Statistics:
- no statistics applied
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- >= 1 000 - <= 2 000 mg/kg bw
- Mortality:
- At 2000 mg/kg, 3 of 5 males and all females were found dead within 7 hours after administration of the test article. At 1000 mg/kg, all animals survived to the scheduled sacrifice.
- Clinical signs:
- other: In-life observations indicating treatment related systemic effects such as dyspnea, reduced locomotor activity, convulsions, hunched posture and piloerection were recorded in both sexes at 2000 mg/kg. Tremor, ataxia, diarrhea and ventral recumbency were l
- Gross pathology:
- At necropsy, no deviations from normal morphology were found in all animals.
- Other findings:
- not applicable
Any other information on results incl. tables
Tab. 1: Mortality data
Dose group | No. of deaths | % deaths | Animal No./died: time after administration (h = hours, d = days) |
Males | |||
1000 mg/kg | 0 / 5 | 0 | |
2000 mg/kg | 3 / 5 | 60 | 4 (2h), 1 (7h) 5 (Id) |
Females | |||
1000 mg/kg | 0 / 5 | 0 | |
2000 mg/kg | 5 / 5 | 100 | 1 (4h), 2 - 4 (5h), 5 (Id) |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The LD50 in rats of both sexes was approximately determined to be greater than 1000 but lower than 2000 mg/kg body weight. Based on this study result, acc. to the new OECD classification system for chemicals CA 2343 would be classified as category 4 concerning its acute oral toxic effects.
- Executive summary:
The purpose of this study was to evaluate the oral acute toxicity of test item CA 2343 (oxadiazinamin; intermediate of CGA 293343), acc. to OECD Guideline 401. Upon single dose, oral administration of 1000 and 2000 mg/kg to male and female rats and a 14 day post-treatment observation period, the following LD50 was determined . At 2000 mg/kg CA 2343 A elicited evident signs of acute toxicity and mortality in male and female rats. Signs of acute toxicity, but no mortality, were seen after treatment with 1000 mg/kg. Therefore the LD50 in rats of both sexes was approximately determined to be greater than 1000 but lower than 2000 mg/kg body weight. Based on this study result, acc. to the new OECD classification system for chemicals CA 2343 would be classified as category 4 concerning its acute oral toxic effects.
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