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Toxicological information

Acute Toxicity: oral

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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:
1975
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

Constituent 1
Chemical structure
Reference substance name:
Glycerol trinitrate
EC Number:
200-240-8
EC Name:
Glycerol trinitrate
Cas Number:
55-63-0
Molecular formula:
C3H5N3O9C3H5(NO3)3
IUPAC Name:
1,3-bis(nitrooxy)propan-2-yl nitrate
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

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:
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