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EC number: 435-740-7 | CAS number: 94317-64-3
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 12 August 1994 and 12 December 1994.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Details on test material:
- Sponsor's identification: N-(n-butyl) thiophosphoric triamide (NBPT)
-Substance type: Organic
Physical state:: Light-tan, waxy solid
Analytical purity: 87 %
Batch number: Not reportded
Date received: Not reported
Storage conditions: The test material was stored refrigerated before the range-finding study, then was moved to room temperature storage.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Cr1:CD®(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Age at study initiation: Young adult
- Weight at study initiation:
15 male and 15 female rats, weighing from 240 to 294 g
- Fasting period before study:
approximately 17 to 20 hours before test material administration
- Housing:
the animals were separated by sex and group housed in screen-bottom stainless steel cages in temperature- and humidity-controlled quarters. During the range-finding study, the animals were individually housed.
- Diet (e.g. ad libitum):
Laboratory Rodent Diet #5001, PMI Feeds, Inc.
- Water (e.g. ad libitum):
Ad libitum from an automatic system. Samples of the water are analyzed by HWI for total dissolved solids, hardness, and specified microbiological content and for selected elements, heavy metals, organophosphates, and chlorinated hydrocarbons
- Acclimation period:
At least 7 days
-Contaminants:
There were no known contaminants in the feed or water at levels that would have interfered with or affected the results of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 25°C
- Humidity (%):
50% ± 20%,
- Air changes (per hr):
Not stated
- Photoperiod (hrs dark / hrs light):
12-hour light/12-hour dark cycle.
IN-LIFE DATES:
In-life Start Date: 18 August 1994
In-life Termination Date: 4 October 1994
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Not reported
- Amount of vehicle (if gavage): Not reported
- Justification for choice of vehicle: Not reported
MAXIMUM DOSE VOLUME APPLIED:
20 mL/kg of body weight
DOSAGE PREPARATION:
The test material was mixed with distilled water to a specific concentration for each dose level. Each prepared test mixture appeared to be a suspension. An individual dose of each respective test mixture was calculated for each animal based on its fasted body weight and administered by gavage to a volume of 20 mL/kg of body weight. The test mixtures were stored at room temperature until administered.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Not reported - Doses:
- Range-Finding Study:
500, 1,000, 3,000, and 5,000 mg/kg bw
Definitive Study:
1,000, 2,500, and 5,000 mg/kg bw (Males)
1,000, 2,500, and 3,000 mg/kg bw (females) - No. of animals per sex per dose:
- Range-finding Study:
eight healthy, acclimated rats (one/sex/dose level)
Definitive Study:
5 males and 5 females per dose level - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
The range-finding animals were observed for mortality only on the day of treatment and for 14 days thereafter. Clinical observations and mortality checks for the definitive study animals were conducted at approximately 1, 2.5, and 4 hours after test material administration. Additional clinical observations and twice a day mortality checks (morning and afternoon) were conducted daily thereafter for 14 days.
Body weights for range-finding and definitive study animals were determined before test material administration (Day 0). Additional body weights were determined at Day 7, at termination of the experimental phase (Day 14), or at death when survival exceeded 1 day.
- Necropsy of survivors performed:
Yes
- Other examinations performed:
Clinical signs. - Statistics:
- The LD50 value for males, females, and the sexes combined was determined by a computer program using a modified Behrens-Reed-Muench cumulant method. No other statistical analyses were required by the protocol.
Results and discussion
- Preliminary study:
- Not applicable.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 536 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 147 - 5 824
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 603 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 885 - 3 595
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 823 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 823 - 3 652
- Mortality:
- All mortality occurred within 2 days of test material administration. Based on the observed mortality, the estimated oral LD50 in rats was determined to be 3,536, 2,603, and 2,823 mg/kg for males, females, and the sexes combined, respectively.
- Clinical signs:
- other: Clinical signs of toxicity included thin appearance, hunched posture, staggered gait, hypoactivity, absence of pain and/or righting reflex, hypothermic to touch, prostration, red or yellow-stained face, lacrimation, miosis, excessive salivation, dyspnea,
- Gross pathology:
- There were 10 rats (five males and five females) each from dose levels of 1,000 and 2,500 mg/kg, five females from a dose level of 3,000 mg/kg, and five
males from a dose level of 5,000 mg/kg necropsied. Some animals died on test (DOT) and the remaining surviving animals were euthanized and necropsied at
the termination of the study.
At necropsy, the most prominent finding in the DOTs pertained to coloration changes and the contents of the gastrointestinal tract. The stomach and small
intestines contained yellow oily semifluid which possibly represented test material mixed with ingesta. The urinary bladder in some animals were apparently distended with yellow or red fluid. The bladder wall or mucosa in two animals given 5,000 mg/kg was diffusely dark red or had multiple dark red areas of variable size. These changes were possibly caused by the test material but may also be related to post mortem autolysis. All remaining observations in these animals andthe animals surviving to study termination were considered incidental findings and unrelated to the test material. - Other findings:
- - Organ weights:
Not recorded
- Histopathology:
Not recorded
- Potential target organs:
Not recorded
- Other observations:
Not recorded
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material in the young adult albino rats of the Crl:CD®(SD)BR strain procured from Charles River Laboratories, Inc., Portage, Michigan. The method was designed to meet the EPA Guidelines: EPA OTS 798.1175 (Acute Oral Toxicity).
Method.
The objective of this study was to assess the acute oral toxicity produced when the test material is administered by the oral route (gavage) to rats.
The test material, N-(n-butyl) thiophosphoric triamide (NBPT), was evaluated for its acute oral toxicity potential in male and female rats when administered as a single gavage dose at levels of 1,000, 2,500, and 5,000 mg/kg of body weight in males and at 1,000, 2,500, and 3,000 mg/kg in females. The estimated oral LD50 in rats was determined to be 3,536, 2,603, and 2,823 mg/kg for males, females, and the sexes combined, respectiv
Mortality.
All mortality occurred within 2 days of test material administration.
Clinical Observations.
Clinical signs of toxicity included thin appearance, hunched posture, staggered gait, hypoactivity, absence of pain and/or righting reflex, hypothermic to touch, prostration, red or yellow-stained face, lacrimation, miosis, excessive salivation, dyspnea, bradypnea, soft stool, wet urogenital area, and dark- or yellow-stained urogenital area. All surviving animals returned to a normal appearance by Day 5 after treatmen
Bodyweight.
There was no meaningful effect on body weight gain in surviving animal
Necropsy.
Test material-related findings observed at necropsy were limited to those animals dying during the study and pertained to coloration changes and the contents of the gastrointestinal tract
Conclusion.
The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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