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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 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:
- 1 996
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal 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: 93.7 %
- Purity test date:
- Lot/batch No.: P.503005
- Staorage conditions: 0 - 5°C
- Reanalysis date: December 1996
- Safety precautions: gloves and face mask
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-88397 Biberach
- Age at study initiation: 2-3 month
- Weight at study initiation: 2700-2970 g
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum standard rabbit pellét - NAFAG 814., NAFAG, Gossau/SG, Switzerland
- Water (e.g. ad libitum): ad libitum fresh water which fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.5% (w/v) carboxymethylcelllose in 0.1% (w/v) aqueous polysorbate 80
- Controls:
- other: A control gauze patch was applied to the contralateral flank of each animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 % (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polyorbate 80 - Duration of treatment / exposure:
- The patches with the test substance were held in place for 4 hours by an adhesive tape.
- Observation period:
- The degree of skin reactions was evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. In case of persisting skin reactions on day 3 after gauze patch removal. the observation period may be extended.
Animals were observed for 7 days to determine the reversibility of the skin reactions. - Number of animals:
- The test was performed on 3 male rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm² of the right flank of each animal
- Type of wrap if used: adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg)
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema ...................................................................................................................................................0
Very slight erythema (barely perceptible) .................................................................................................1
Well defined erythema ...................................................................................................................................2
Moderate to severe erythema ......................................................................................................................3
Severe erythema (beef redness) to eschar formation preventing grading of erythema.....................4
Maximum possible: 4
Oedema Formation
No oedema........................................................................................................................................................0
Very slight oedema (barely perceptible) ......................................................................................................1
Slight oedema (edges of area well defined by definite raising) ................................................................2
Moderate oedema (raised approximately 1 mm) ........................................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ............................4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h, 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 72 h
- Remarks on result:
- other: found dead due to a damaged kidney after an accident during examination
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h, 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h, 24 h, 48 h, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h, 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 48 h, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
The mean of 24 - 72 hours for
erythema scores:
animal 1 = 0 (found dead after 72 hours, therefore mean 24 - 48 h, see also remark above)
animal 2 = 0.33
animal 3 = 1
Edema scores:
animal 1 = 0 (found dead after 72 hours, therefore mean 24 - 48 h, see also remark above)
animal 2 = 0
animal 3 = 0.33
Observed skin reactions were fully reversed in surviving animals by day 7.
No erythema and edema were observed on the control flanks of each animal at all times
Body weights were unaffected by the treatment. There were no remarkable in –life observations.
Table of body weights: (all animals are male ones)
Animal No |
639 (1) |
643(2) |
(3) 653 |
At start of test |
2970 |
2890 |
2700 |
After 3 days |
Ex. 2910 |
2960 |
2780 |
After 7 days |
- - - |
3010 |
2850 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Very slight erythema was recorded in all rabbits 1 hour after gauze patch removal, in 2 of 3 animals after 24 hours and in 1 animal at up to 72 hours. Very slight edema was seen in 2 of 3 animals 1 hour after gauze patch removal and in 1 animal after 24 hours.
Observed skin reactinos were fully reversed in surviving animals by day 7 after removal of the gauze patches. - Executive summary:
This study has been performed in compliance with Good Laboratory Practice (GLP) in . The study has been conducted according to OECD guideline 404 adopted July 17, 1992, 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).
A gauze patch with 0.5 test material (oxadiazinamine), moistened with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80, was placed on the shaved skin of three male rabbits and loosely covered with aluminium foil for 4 hours. The controlateral flank was covered with a control patch moistened with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80 and with aluminium foil.
The animals were checked daily for mortality and systemic symptoms. Body weights were recorded at start, after three days and on conclusion of the study on day seven. Skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Animals were observed for 7 days to determine the reversibility of the skin reactions.
One animal was found dead on day 3 due to a damaged kidney after an accident during examination. No systemic symptoms were recorded in any of the test animals. Body weight development was within a normal range.
Grade 1 erythema and/or oedema were seen in the test animals 1 hour and 24 hours after gauze patch removal, erythema still existing existing in one animal after 72 hours.
Observed skin reactions were fully reversed in surviving animals by day 7.
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 skin irritating.
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