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EC number: 609-724-7 | CAS number: 39605-45-3
- 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:
- Jun 1990 - Feb 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 OTS 798.1175 (Acute Oral Toxicity)
- Version / remarks:
- 1985
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Version / remarks:
- 1982
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Terbuthylazine
- EC Number:
- 227-637-9
- EC Name:
- Terbuthylazine
- Cas Number:
- 5915-41-3
- Molecular formula:
- C9H16ClN5
- IUPAC Name:
- N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: OFA.SD. (IOPS Caw.)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Crédo, France
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 121-161 g
- Housing: group (5)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25
- Humidity (%): 34-90
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10%, 15.9%, 25.1% (w/v)
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION: prepared about 2.5 h before administration
- Doses:
- 1000, 1590, 2510 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: yes
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Bliss' method, Litchfield and Wilcoxon's method to calculate LD50
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- < 1 590 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 503 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 030 - <= 2 194
- Mortality:
- 1000 mg/kg: Mortality observed from Day 3 onwards both in males and females
1590 mg/kg: mortality observed from Day 2 (males only) onwards. From Day 3 both sexes affected
2510 mg/kg: mortality observed from Day 2 (males only) onwards. From Day 3 both sexes affected - Clinical signs:
- other: 1000 mg/kg: subdued behavior in all animals 4 h after administration, piloerection in half on Day 2, diarrhoea on Day 3 (one animal). All surviving rats recovered on Day 4. 1590 mg/kg: subdued behavior in all animals 4 h after administration, prostration
- Gross pathology:
- Abnormalities which were observed in animals dead during the study were mainly characterised by a marked congestion of the lungs. One male of group 3 presented with abdominal dropsy (cloudy liquid). No abnormality was noted in animals killed at the end of the study.
Any other information on results incl. tables
Table 1: Mortality observed in the study
Dose level (mg/kg) |
Mortality (%) after 15 days |
||
Males |
Females |
Males + Females |
|
0 |
0 |
0 |
0 |
1000 |
40 |
20 |
30 |
1590 |
60 |
60 |
60 |
2510 |
40 |
80 |
60 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under the conditions chosen, mortality was observed from 1000 mg/kg onwards. The LD50 for females (most sensitve) was calculated to be 1503 mg/kg.
- Executive summary:
The test article was administered once only, in suspension in purified water and at the dose levels of 1000, 1590 and 2510 mg/kg, by the oral route (gastric gavage), in the Sprague-Dawley rat (5 males + 5 females per group). This study was performed in comparison with a control group of 10 rats (5 males + 5 females) treated with the vehicle under the same conditions. Mortality and abnormal clinical signs were noted 15 minutes after intubation, then at 1, 2 and 4 hours, and then daily for the l4 day study period. All the animals were weighed the day before treatment (Day-l), immediately before administration of the test article (Day 1), on Days 8 and 15, as well as at time of death from Day 2 onwards. A necropsy was performed for all the animals dead during the study and for all surviving rats after the l4 day study period and the final observation (Day 15). Mortality was observed from the lowest concentration onwards. The LD50 for males, females and males and females combined was calculated with the Bliss' method to be < 1590 mg/kg, 1503 mg/kg, and 1590 mg/kg, respectively.
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