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EC number: 602-927-1 | CAS number: 123312-89-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Jul 1991 to 4 Sep 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- 1985
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
- EC Number:
- 602-927-1
- Cas Number:
- 123312-89-0
- Molecular formula:
- C10H11N5O
- IUPAC Name:
- 6-methyl-4-[(E)-[(pyridin-3-yl)methylidene]amino]-2,3,4,5-tetrahydro-1,2,4-triazin-3-one
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd:Sprague Dawley SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 216 to 294 g (for males), 204 to 268 g (for females)
- Fasting period before study: Yes, approximately 17 to 20 hours before test material administration when food, but not water, was withheld.
- Housing: individually housed in screen-bottom, stainless steel cages (heavy gauge).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Animal husbandry and housing comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals" (NIH publication number No. 86-23, revised 1985). Variations from the prescribed environmental conditions existed and were considered to have had no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
IN-LIFE DATES:
July 18 to September 4, 1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Destilled
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: 20.00 mL/kg body weight - Doses:
- 4000, 5000, 6000, 6500, or 7000 mg/kg of body weight based on range-finding study using the following doses: 1000, 2000, 4000 and 5000 mg/kg of body weight performed with one animal/sex/dose.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were determined before test material administration (Day 0). Additional body weights were determined at Day 7 and at termination of the experimental phase (Day 14) or at death when survival exceeded 1 day.
- Necropsy of survivors performed: yes, All study animals, whether dying during the study or euthanatized, were subjected to a gross necropsy examination and all abnormalities were recorded. After necropsy, the animals were discarded and all tissues with lesions were collected for possible future histological evaluation.
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Clinical signs and mortality checks were conducted at approximately 1, 2.5, and 4 hours after test material administration. Additional clinical signs and twice a day mortality checks (morning and afternoon) were conducted daily thereafter for 14 days. - Statistics:
- The LD50 value for males, females, and the sexes combined was determined by a computer program utilizing probit analysis. No other statistical analyses were required by the protocol.
Results and discussion
- Preliminary study:
- No mortality was observed at levels of 1000, 2000, 4000, or 5000 mg/kg. All animals exhibited weight gain with the exception of one male rat which exhibited a weight loss of 8 g during the first week of the study.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 693 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5 955 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 820 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 4000 mg/kg bw there was no mortality. Most deaths at the higher dose levels occurred from day 7 to 13. A data overview can be found in 'Any other information on results incl. tables'.
- Clinical signs:
- other: The observed signs included hypoactivity, staggered gait, prostration, red-stained face, lacrimation, dyspnea, soft stool, stained urogenital area, redstained urine, tremors, and hypothermia.
- Gross pathology:
- At necropsy, the most prominent findings were in the DOTs and pertained to the contents and coloration changes in the gastrointestinal tract. The stomach and small intestines contain material of varied consistency and colour that probably represent test material mixed with ingestions. Some of the observations were also attributed to post-mortem change and autolysis or were considered common incidental findings. There were no visible lesions in the animals surviving to the end of the test periods.
Any other information on results incl. tables
Table 1. Mortality incidence
Dose (mg/kg bw) |
Mortality |
Onset of death |
Males |
|
|
4000 |
0/5 |
|
5000 |
1/5 |
Day 4 |
6000 |
3/5 |
Days 11, 11, 13 |
6500 |
4/5 |
Days 7, 8, 8, 9 |
7000 |
5/5 |
Days 2, 4, 9, 11 |
Females |
|
|
4000 |
0/5 |
|
5000 |
1/5 |
Day 8 |
6000 |
2/5 |
Days 1, 10 |
6500 |
3/5 |
Days 7, 9, 10 |
7000 |
5/5 |
Days 2, 5, 8, 9, 10 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study according to EPA 81-1 guideline the following LD50 values were found: 5693 mg/kg for males and 5955 mg/kg for females.
- Executive summary:
In this GLP compliant acute oral toxicity study performed according to EPA guideline 81-1, the test material was evaluated for its acute oral toxicity potential in male and female albino rats (Hsd:Sprague Dawley SD) when administered as a single gavage dose at levels of 4000, 5000, 6000, 6500, and 7000 mg/kg of body weight (5 animals/sex/dose). The test material was dissolved in water. After single exposure, rats were observed for 14 days. Mortality increased with increasing dosis: 0/10, 2/10, 5/10, 7/10 and 10/10 animals receiving 4000, 5000, 6000, 6500 and 7000 respectively. Clinical signs of toxicity included hypoactivity, staggered gait, prostration, red-stained face, lacrimation, dyspnea, soft stool, yellow/red/ or darkstained urogenital area, red-stained urine, tremors, hypothermic to touch, and death. There was no meaningful effect on body weight gain in those animals surviving to termination with the exception of two males which exhibited weight losses of 30 g each during the first week of the study. The most prominent findings observed at necropsy were in the animals dying during the study and pertained to the contents and coloration changes in the gastrointestinal tract. The calculated (probit analysis) oral LD50 was determined to be 5693, 5955, and 5820 mg/kg for males, females, and the sexes combined, respectively.
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