Registration Dossier
Registration Dossier
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EC number: 200-240-8 | CAS number: 55-63-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1.4.1974-31.5.1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Method followed: Intragastic intubation.
- GLP compliance:
- not specified
- Remarks:
- Unlikely (year performed 1975)
- Test type:
- other: Single dose (acute) oral LD50
Test material
- Reference substance name:
- Glycerol trinitrate
- EC Number:
- 200-240-8
- EC Name:
- Glycerol trinitrate
- Cas Number:
- 55-63-0
- Molecular formula:
- C3H5N3O9 C3H5(NO3)3
- IUPAC Name:
- propane-1,2,3-triyl trinitrate
- Details on test material:
- - Name of test material (as cited in study report): trinitroglycerin (TNG, NG)
- Substance type: organic substance
- Physical state: a 10% mixture in lactose
- Source: ICI America-Atlas Chemical Division (Chicago Illinois)
- Analytical purity: 9.72 % +/- 0,09% in lactose
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: National Laboratory Animal Company (O´Fallon, Missouri)- Fasting period before study: at least 16 hours- Housing: plastic cages with hardwood bedding- Diet (e.g. ad libitum): Purina rodent chow ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): 23.9 +/- 2.8 oC- Humidity (%): 50 +/- 10%- Photoperiod (hrs dark / hrs light): photoperiod of 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 3.41% NG - Amount of vehicle (if gavage): 65% peanut oilDOSAGE PREPARATION (if unusual):The lactose mixture was further diluted with peanut oil to give a solution/suspension containing 3.41 % NG (by G-C analysis), 31.5% lactose and 65% peanut oil.
- Doses:
- Not given in report.
- No. of animals per sex per dose:
- Not reported. Probably 10 males and 10 females/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days- Frequency of observations: daily for delayed mortality or toxic signs- Necropsy of survivors performed: no necropsies- Other examinations performed: clinical signs
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 055 mg/kg bw
- 95% CL:
- 895 - 1 178
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 188 mg/kg bw
- 95% CL:
- 1 008 - 1 352
- Mortality:
- Death usually occured within 5 to 6 hours of dosing.
- Clinical signs:
- other: Within 1 hour after dosing, all the animals became cyanotic and ataxie. The ears, nose, eyes, paws and tail appeared very pale and the respiration was depressed. Recovery usually complete in 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
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