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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-07-11 till 1996-08-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study without deviations
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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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 on 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, D-88397 Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 3560 to 3992 g
- Housing: The animals were housed individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet - NAFAG 814
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: control area on the same animal (right eye)
- Amount / concentration applied:
- 100 ml, i.e. 47 mg per animal
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after treatment
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after treatment
- Score:
- 0 - 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after treatment
- Score:
- 0 - 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, and 72 hours after treatment
- Score:
- 0 - 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Mean scores of 24 through 72 hours after ocular administration indicated moderate circumcorneal hyperemia of the iris in rabbit no. 424.
Conjunctival hyperemia with injected blood vessels was noted in all rabbits, and above normal swelling of eye lids in one rabbit.
The observed eye reactions were completely reversible in all rabbits within 2 days. - Other effects:
- Body weights (Table 2) were unaffected by the treatment. There were no remarkable in-life observations.
Any other information on results incl. tables
animal no. | 424 | 480 | 482 | |
conjunctiva / redness | 0.33 | 0.33 | 0.33 | |
conjunctiva / chemosis | 0.33 | 0 | 0 | |
cornea | 0 | 0 | 0 | |
iris | 0.33 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since the mean irritation scores 24 to 72 hours after instillation were below the thresholds defined in Commission Directive 93/21/EEC
(18th adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA
293343) as to its eye irritating properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP). - Executive summary:
An acute eye irritation/corrosion study was performed with White New Zealand Rabbit acc. to OECD Guideline 405.
Mean scores of 24 through 72 hours after ocular administration indicated moderate circumcorneal hyperemia of the iris in one rabbit. Conjunctival hyperemia with injected blood vessels was noted in all rabbits and above normal swelling of eye lids in one rabbit. The observed eye reactions were completely reversible in all rabbits within 2 days. All animals survived to the scheduled sacrifice. There were no remarkable in-life observations.
Since the mean irritation scores 24 to 72 hours after instillation were below the thresholds defined in Commission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), classification of CA 2342 A (Intermediate of CGA 293343) as to its eye irritating properties is not required. This classification still applies to the recent versions of both UN-GHS and EU-GHS (CLP).
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