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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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August - October 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- This study was performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerland.
- Test type:
- standard acute method
- Limit test:
- yes
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 (Intermediate of CGA 293343)
- Physical state: fine, white powder
- Batch No.: P.503005
- Contents/ Purity: 96.7 %
- Storage condition of test material: 0 - 5 °C
- Test material received: August 16, 1995
- Date of reanalysis: December 1996
- VB: 61580
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI F (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ciba-Geigy Limited, Animal Production, Stein, Switzerland
- Age at study initiation: young adults
- Initial body weight range at study initiation: 213 to 270 g
- Housing: individuals in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet: ad libitum (NAFAG 890, NAFAG, Gossau/SG, Switzerland)
- Water: ad libitum
- Acclimation period: at least 5 days before exposure
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2 °C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqeous polysorbate 80
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: 10 % of body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight (equivalent to 4 ml/kg body weight)
- Constant volume or concentration used: yes
VEHICLE
- Concentration (if solution): (0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqeous polysorbate 80) - Duration of exposure:
- exposure: 24 hours;
observation period after exposure: 14 days - Doses:
- One single dose (2000 mg/kg body weight);
rationale for dose selection: the dose level was selected according to OECD 402 (limit test; single application of at least 2000 mg/kg body weight). - No. of animals per sex per dose:
- 5 (total number of animals: 10)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (signs and symptoms): daily for 14 days
- Frequency of observations (mortality): daily; a.m. and p.m. on working days, a.m. on weekends
- Frequency of weighing: immediately before application and on day 7 and 14
- Necropsy of survivors performed: yes, at the end of the observation period - Statistics:
- Statistics on body weight changes, see "Remarks on results including tables and figures".
Results and discussion
- Preliminary study:
- No
Effect levels
- Sex:
- male/female
- 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 related to toxicity of the test article after single dose, dermal application. There were no remarkble findings at the application site of all animals. Neither mortality nor body weights were affected by the treatment.
- Gross pathology:
- At necropsy, no deviations from normal morphology were found.
- Other findings:
- None.
Any other information on results incl. tables
In-life observations
|
|
Time after dermal administration (days) |
||||||||||||||
Animal No. |
Observations |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1-5, males |
No remarkable findings |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
1-5, females |
No remarkable findings |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
Local Tolerance, 2000 mg/kg (application site)
|
|
Time after dermal administration (days) |
||||||||||||||
Animal No. |
Observations |
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
1-5, males |
No remarkable findings |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
1-5, females |
No remarkable findings |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
Body weight and necropsy findings, 2000 mg/kg, males
Animal number |
Body weights (g) |
* |
Gross necropsy findings |
||
Day 0 |
7 |
14 |
|
|
|
1 |
270 |
308 |
347 |
TS |
No observable abnormalities |
2 |
266 |
302 |
335 |
TS |
No observable abnormalities |
3 |
252 |
296 |
338 |
TS |
No observable abnormalities |
4 |
257 |
287 |
317 |
TS |
No observable abnormalities |
5 |
264 |
296 |
330 |
TS |
No observable abnormalities |
mean |
262 |
298 |
333 |
|
|
SD |
7.2 |
7.8 |
11.1 |
|
|
Body weight and necropsy findings, 2000 mg/kg, females
Animal number |
Body weights (g) |
* |
Gross necropsy findings |
||
Day 0 |
7 |
14 |
|
|
|
1 |
213 |
221 |
239 |
TS |
No observable abnormalities |
2 |
250 |
273 |
265 |
TS |
No observable abnormalities |
3 |
227 |
234 |
239 |
TS |
No observable abnormalities |
4 |
228 |
239 |
257 |
TS |
No observable abnormalities |
5 |
220 |
240 |
251 |
TS |
No observable abnormalities |
mean |
228 |
241 |
250 |
|
|
SD |
13.9 |
19.2 |
11.4 |
|
|
* TS: terminal sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- At 2000 mg/kg, CA 2343 A (intermediate of CGA 293343) elicited no signs of acute toxicity after single dose, dermal administration in male and female rats.
- Executive summary:
In an acute dermal toxicity study (OECD 402, limit test), 10 young adult albino rats (Tif: RAI f (SPF)) of both sexes (5 animals per group) were dermally exposed to CA 2343 A) intermediate of CGA 293343) in 0.5 % (w/v) carboxymethylcellulose (in 0.1 % (w/v) aqueous polysorbate 80) for approximately 24 hours to 10% of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Males >2000 mg/kg bw
Females >2000 mg/kg bw
Combined >2000 mg/kg bw
There were no in-life observations related to toxicity of the test article after single dose, dermal application.
There were no remarkble findings at the application site of all animals.
Neither mortality nor body weights were affected by the treatment.
At the autopsy, no deviations from normal morphology were found.
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.
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