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EC number: 201-861-7 | CAS number: 88-85-7
- 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:
- 22 August 1984 to 5 September 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in accordance with recognised guideline. Although no data is available on the study's GLP compliance equivalent quality assurance methods were in place at the testing laboratory. The substance is present in an oil formulation at ca.30% and a purity correction performed to give the LD50 of the substance itself.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Remarks:
- QA and study director statements included in the report
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dinoseb
- EC Number:
- 201-861-7
- EC Name:
- Dinoseb
- Cas Number:
- 88-85-7
- Molecular formula:
- C10H12N2O5
- IUPAC Name:
- dinoseb
- Details on test material:
- - Name of test material (as cited in study report): DNBP formulation
- Physical state: brown liquid
- Analytical purity: 30 - 31.2% w/w DNBP in oil.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HC/CFY (Remote Sprague-Dawley)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Limited, Huntingdon, Cambridgeshire, England
- Age at study initiation: approximately four to six weeks
- Weight at study initiation: 104 to 128 g
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing
- Housing: metal cages with wire mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum period of 6 days prior to the start of the main study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 25°C
- Humidity (%): ca. 68%
- Air changes (per hr): approximately 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period
IN-LIFE DATES: From 22 August to 5 September 1984.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- No vehicle used
MAXIMUM DOSE VOLUME APPLIED:
- not exceeding 0.16 ml/kg bw - Doses:
- Three dose levels of 64, 100 and 160 mg/kg bodyweight
- No. of animals per sex per dose:
- 64 mg/kg bw - 5m, 5f
100 mg/kg bw - 5m, 5f
160 mg/kg bw - 5m, 5f - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days in the main study, 5 days in the preliminary study
- Frequency of observations and weighing: Animals were observed soon after dosing; then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice per day. Clinical signs were recorded at each observation.
- Necropsy of survivors performed: yes
- Other examinations performed: Approximate time of death of individual rats. The nature, severity, approximate time of onset and duration of each toxic sign were recorded, also individual bodyweights of rats on Days 1 (day of dosing), 8 and 15 and at death. - Statistics:
- The acute median lethal oral dose (LD50) to male and female rats was calculated using the method of:
Finney (1971) Probit Analysis (3rd Edition) Cambridge University Press.
Separate LD50 values for males and females were estimated by undertaking probit analysis on the mortality data by fitting two parallel lines on the data (males only and females only) using the technique described by Finney (1978, Statistical Method in Biological Assay, 3rd Edition, Charles Griffin, London). A chi-squared test was carried out to check that the data did not contain any evidence for non-parallelism.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 80 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 64 - 97
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 80 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 59 - 106
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 80 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 59 - 106
- Mortality:
- Mortalities occurred amongst rats at dose levels of 64 mg/kg and above from within three to eight hours of dosing.
- Clinical signs:
- other: Signs of reaction to treatment observed shortly after dosing in all treated animals included pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy and increased salivation. These signs were accompanied by: pallor of t
- Gross pathology:
- Autopsy revealed congestion of the lungs and pallor of the liver, kidneys and spleen among animals that died during the study. Terminal autopsy findings for animals sacrificed at the end of the study were normal.
Any other information on results incl. tables
Time and number of deaths of rats dosed orally with DNBP formulation in the main study
Sex |
dose |
Number of deaths in group of 5 |
Day |
||||||||
1 |
2 to 15 |
||||||||||
Hours after dosing |
|||||||||||
2 |
3 |
4 |
5 |
6 |
7 |
8 |
1st observ. |
2nd observ. |
|||
m |
64 |
1 |
|
|
|
|
1 |
|
|
|
|
100 |
4 |
|
1 |
|
1 |
2 |
|
|
|
|
|
160 |
5 |
|
5 |
|
|
|
|
|
|
|
|
f |
64 |
1 |
|
|
|
|
|
|
1 |
|
|
100 |
4 |
|
|
2 |
2 |
|
|
|
|
|
|
160 |
5 |
|
1 |
3 |
|
1 |
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- other: toxic
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The LD 50 of the formulation has been determined to be 80 mg/kg bw in both male and female rats, which is approximately equivalent to an LD50 of 24 mg/kg bw for the active substance. The substance is therefore classified as toxic.
- Executive summary:
In an acute oral toxicity study conducted in accordance with OECD method 401 and under an appropriate quality assurance system, groups of 5 male and 5 female rats were dosed with a preparation of the substance in oil, at dose levels that gave equivalent concentrations of the substance itself as 64, 100 and 160 mg/kg bodyweight; the animals were observed for 14 days after treatment. The LD50 of the substance as tested was determined to be 80 mg/kg bw to both male and female rats which is equivalent to approximately 24 mg/kg bw for the active ingredient.
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