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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:
- August - September 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study; documentation sufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- This study was performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986. These procedures are based on the OECD Principles of GLP, adopted May 12, 1981 by Decision of the OECD Council C(81)30(Final)
Test material
- Reference substance name:
- -
- EC Number:
- 431-060-1
- EC Name:
- -
- Cas Number:
- 153719-38-1
- Molecular 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
- Substance type: Intermediate of CGA 293343
- Physical state: powder
- Analytical purity: 96.7%
- Lot/batch No.: P.503005
- Storage condition of test material: 0-5°C
- Date of Reanalysis: December 1996
- Safety precautions: gloves and face masks
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
- Weight at study initiation: 2690 - 2970 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellet (NAFAG 814, NAFAG, Gossau/SG, Switzerland)
- Water (e.g. ad libitum): ad libitum, water quality fulfilled the critical parameters in the specification of the "Schweizerisches Lebensmittelhandbuch"
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untereated eye of the animals served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml corresponding to about 57 mg - Duration of treatment / exposure:
- one-time administration
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM: OECD guideline 405 - Scores for ocular lesions (see below) and
Classification of Irritant Potency (not shown) according to Annex iV, 3.2.6 of Council Directive 67/548/EEC (Commision Directive 93/21/EEC of April, 1993; Official Journal of the European Communities No. L 110 A, May 4, 1993).
Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity.............................................................................................................................. 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible ...................................................................................................................... 1
Easily discernible translucent area; details of iris slightly obscured ............................................................2
Nacrous area; no details of iris visible; size of pupil barely discernible ......................................................3
Opaque cornea; iris not discernible through the opacity ..............................................................................4
Maximum possible: 4
* The area of corneal opacity should be noted
Iris
Normal .........................................................................................................................................................0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect ..................................1
Hemorrhage, gross destruction, or no reaction to light .................................................................................2
Maximum possible: 2
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal .........................................................................................................................................................0
Some blood vessels hyperaemic (injected) ...................................................................................................1
Diffuse, crimson colour; individual vessels not easily discernible ...............................................................2
Diffuse beefy red..........................................................................................................................................3
Maximum possible: 3
Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal .........................................................................................................................................................0
Some swelling above norma .........................................................................................................................1
Obvious swelling, with partial eversion of lids.............................................................................................2
Swelling, with lids about half closed ............................................................................................................3
Swelling, with lids more than half closed .....................................................................................................4
Maximum possible: 4
Results and discussion
In vivo
- Irritant / corrosive response data:
- see below in rich-text-field: "Remarks on results including tables and figures"
The mean scores of 24 through 72 hours after ocular administration indicated moderate circumscorneal hyperemia of the iris in normal swelling of eyelids inall rabbits. Diffuse areas of corneal opacity were noted in 2 of 3 rabbits. Observed eye reactions were completely reversible in all rabbits within 7 days.
Any other information on results incl. tables
All tables: First number given is always the control eye. The second number is the test eye.
Table 1: Irritant/corrosive response data for animal 1 (female) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/1 |
0/1 |
0/2 |
0/2 |
24 h |
0/1 |
0/1 |
0/2 |
0/1 |
48 h |
0/0 |
0/1 |
0/1 |
0/1 |
72 h |
0/0 |
0/0 |
0/1 |
0/0 |
Average 24h, 48h, 72h |
0/0.33 |
0/0.67 |
0/1.33 |
0/.67 |
7 days |
0/0 |
0/0 |
0/0 |
0/0 |
Table 2: Irritant/corrosive response data for animal 2 (male) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/1 |
0/1 |
0/2 |
0/2 |
24 h |
0/0 |
0/0 |
0/2 |
0/1 |
48 h |
0/0 |
0/0 |
0/1 |
0/0 |
72 h |
0/0 |
0/0 |
0/1 |
0/0 |
Average 24h, 48h, 72h |
0/0 |
0/0 |
0/1.33 |
0/0.33 |
7 days |
0/0 |
0/0 |
0/0 |
0/0 |
Table 3: Irritant/corrosive response data for animal 3 (male) at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
60 min |
0/1 |
0/1 |
0/2 |
0/2 |
24 h |
0/1 |
0/1 |
0/2 |
0/1 |
48 h |
0/0 |
0/1 |
0/1 |
0/0 |
72 h |
0/0 |
0/1 |
0/1 |
0/0 |
Average 24h, 48h, 72h |
0/0.33 |
0/1 |
0/0.33 |
0/0.33 |
7 days |
0/0 |
0/0 |
0/0 |
0/0 |
Table of body weights:
Animal No |
678/female |
007/male |
509/male |
At start of test |
2740 |
2690 |
2970 |
After 3 days |
2780 |
2670 |
3010 |
After 7 days (end) |
2850 |
2910 |
3050 |
A transitory slight loss of body weight in rabbit No. 007 was recorded on experimental day 3.
Mortality was unaffected by the treatment.
Rabbit No. 007 vocalised upon instillation of the test article. Otherwise, thre were no remarkable in-life observations.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- When evaluated according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC oxadiazinamine has not to be classified as eye irritating.
- Executive summary:
This study has been performed in compliance with Good Laboratory Practice (GLP) in . The study has been conducted according to OECD guideline 405 adopted February 24, 1987, by the OECD council, and on Annex V, part B of Council Directive 79/831/EEC (Commission Directive 92/69/EEC of July 31, 1992).
The test article (0.1 ml corresponding to 57 mg) was placed into the conjunctival sac of the left eye of each animal. Lids were then hold together for about 1 second. The untreated eye served as control.
The animals were checked daily for mortality and systemic symptoms. Body weights were recorded at start, after 3 days and on conclusion of the study on day 7. Ocular reactions were evaluated 1, 24, 48, 72 hours after instillation of the test article according to the OECD scoring system. Animals were observed for 7 days to determine the reversibility of the ocular reactions.
There was no mortality. One rabbit vocalised upon instillation of the test compound. No other systemic symptoms were recorded. In one animal, a transitory slight body weight loss was recorded on experimental day 3.
Grade 1 cornea opacity was seen in all test animals 1 hour after test article instillation, and in two animals 24 hours after instillation. Iris lesions were recorded in all test animals 1 hour after test article instillation in two animals 24 hours and 48 hours after instillation in one animal still existing after 72 hours. Conjunctival reactions (redness and/or chemosis) up to grade 2 were noted in all animals at all observation time pints until 72 hours of the test compound. The highest mean score of 24 to 72 hours after instillation was 1.33 for conjunctival redness, thus laying below the threshold of significance.
Observed ocular reactions were fully reversed in all animals by day 7.
When evaluated according to Council Directive 67/548/EEC, adapted to technical progress by Commission Directive 93/21/EEC, the substance oxadiazinamine has not to be classified as eye irritating.
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