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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-08-24 till 1995-10-31
- 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:
- 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
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: mono-constituent organic substance
- Physical state: solid, fine, white powder
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach, Germany
- Age at study initiation: no data
- Weight at study initiation: 2690 to 2970 g
- Housing: The animals were housed individually in metal cages
- Diet (e.g. ad libitum): Rabbits received ad libitum standard rabbit pellet - NAFAG 814, NAFAG, Gossau/SG, Switzerland.
- Water (e.g. ad libitum): fresh water ad libitum
- Acclimation period: at least 5 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
IN-LIFE DATES: From: 1995-08-24 To: 1995-09-12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eyes of the three test animals without treatment served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, corresponding to 57 mg of test item
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- The test item was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article.
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing reported
- Time after start of exposure:
SCORING SYSTEM: OECD scoring system (demonstrated in Appendix 1 of the original study report)
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Remarks:
- animals 1, 2, and 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- other: max. score of 2 reversible after 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (chemosis)
- Basis:
- mean
- Remarks:
- animals 1, 2, and 3
- Time point:
- other: overall score at 24, 48, and 72 h
- Score:
- >= 0.33 - <= 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 d
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animals 1, 2, and 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- >= 0 - <= 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals 1, 2, and 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Irritant data are summarized in the table above. All effects were fully reversible within 7 days at latest
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on a degree of ocular irritation (mean scores of 24 through 72 hours after ocular administration) below threshold values, classification of CA 2343 A (Intermediate of CGA 293343) according to OECD-GHS or Council Directive 67/548/EEC is not required.
- Executive summary:
An acute eye irritation/corrosion study in albino rabbits was performed to determine the irritant and corrosive potency of CA 2343 A (Intermediate of CGA 293343) on albino rabbit eye and associated mucous membranes. This study protocol was based on the OECD Guideline No. 405, and on Annex V, part B of Council Directive 79/831/EEC.
Under the experimental conditions employed, CA 2343 A (Intermediate of CGA 293343) induced reactions of the cornea, iris and conjunctiva, when instilled into the conjunctival sac of albino rabbit eyes.
The following mean scores (24 - 72 h) were calculated:
Conjunctivae score (rednenss): mean 1.33, max. 2
Conjunctivae score (chemosis): mean 0.33 - 0.67, max. 1
Cornea score: 0 - 0.33, max. 1
Iris score: 0 - 1, max. 1
All observed irritating effects were fully revesible within 7 d at latest.
Based on a degree of ocular irritation (mean scores of 24 through 72 hours after ocular administration) below threshold values, classification of CA 2343 A (Intermediate of CGA 293343) according to OECD-GHS or Council Directive 67/548/EEC is not required.
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