Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 433-400-2 | CAS number: 4245-76-5
- 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:
- 1996-07-02 till 1996-08-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 433-400-2
- EC Name:
- -
- Cas Number:
- 4245-76-5
- Molecular formula:
- C2H6N4O2
- IUPAC Name:
- 1-Methyl-3-nitro-guanidine
- Reference substance name:
- N-methyl-N'-nitro-guanidine
- IUPAC Name:
- N-methyl-N'-nitro-guanidine
- Details on test material:
- - Name of test material (as cited in study report): CA 2342 A (Intermediate of CGA 293343)
- Substance type: Intermediate
- Physical state: solid
- Analytical purity: 98%
- Purity test date: reanalysis December 1997
- Lot/batch No.: P.601014
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: white albino (Tif: RAI f (SPF), bred ahd raised on the premises)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Stein / Switzerland
- Age at study initiation: no data
- Weight at study initiation: 173 to 205 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 provided ad libitum
- Water (e.g. ad libitum): provided ad libitum
- Acclimation period: at least for 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-2 °C
- Humidity (%): relative humidity of 55 +/- 10%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours day light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: test substance concentration in vehicle 200 mg/ml
- Amount of vehicle (if gavage): 10 ml per kg body weight
- Justification for choice of vehicle: no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 2.05 ml
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily for 14 days
- Frequency of weighing: before administration and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: There were no in-life observations indicating treatment related systemic effects - Statistics:
- no statistical analysis was used
Results and discussion
- Preliminary study:
- The dose level was selected according to OECD 401 (limit test; single application of 2000 mg/kg body weight).
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived to the scheduled sacrifice.
- Clinical signs:
- other: There were no in-life observations indicating treatment-related systemic effects
- Gross pathology:
- At necropsy, no deviations from normal morphology were found in all animals
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The substance is not classified as acute oral toxic by EU-GHS (CLP), since LD50 > 2000 mg/ kg body weight, which is the cut-off in the EU's GHS classification system. UN-GHS has a Category 5 for acute oral toxicity for the dose range 2000 mg/kg bw < LD50 < 5000 mg/kg bw, a concentration range which has not been tested. However acute toxicity Category 5 is applied by some authorities only. Furthermore, acc. to GHS 3.1.2.5 testing animals in the Category 5 range is discouraged unless "there is a strong likelyhood that results of such testing would have a direct relevance to the protection of human health", which is not the case.
- Executive summary:
An acute oral toxicity test on the rat was performed acc. to OECD Guideline 401. Upon single dose, oral administration of 2000 mg/kg to male and female rats (Limit test) and a 14 day post-treatment observation period, the LD50 of CA 2342 A (Intermediate of CGA 293343) was determined to be greater than 2000 mg/kg body weight in both sexes.
All animals survived to the scheduled sacrifice. There were no in-life observations indicating treatment related systemic effects. A loss of body weight was recorded in one female rat during the second week after treatment. At necropsy, no deviations from normal morphology were found in all animals.
The substance is not classified as acute oral toxic by EU-GHS (CLP), since LD50 > 2000 mg/ kg body weight, which is the cut-off in the EU's GHS classification system. UN-GHS has a Category 5 for acute oral toxicity for the dose range 2000 mg/kg bw < LD50 < 5000 mg/kg bw, a concentration range which has not been tested. However acute toxicity Category 5 is applied by some authorities only. Furthermore, acc. to GHS 3.1.2.5 testing animals in the Category 5 range is discouraged unless "there is a strong likelyhood that results of such testing would have a direct relevance to the protection of human health", which is not the case.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.