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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:
Not stated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results

Data source

Reference
Reference Type:
publication
Title:
Comparative toxicity of synthetic and natural glycerin
Author:
Hine, C
Year:
1953
Bibliographic source:
Arch Ind Hyg Occup Med 7:282-291

Materials and methods

Principles of method if other than guideline:
Groups of rats were dosed orally and observed for 10 days. Gross necropsy was performed on all animals.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Glycerol
EC Number:
200-289-5
EC Name:
Glycerol
Cas Number:
56-81-5
Molecular formula:
C3H8O3
IUPAC Name:
propane-1,2,3-triol
Details on test material:
CAS 56-81-5 (glycerine)
Natural glyerine, achieved from market stock, although purity was not indicated (impurities were fatty acids and esters) it was USP grade material.
Synthetic glycerin, purity 99.5% (rest mainly water with very small amounts of glycerin polymers and glyceraldehyde)

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
female
Details on test animals or test system and environmental conditions:
Rats were obtained from local suppliers and were quarantined for about two weeks prior to use. Metal cages bedded with sawdust housed them in approximately equal groups, which were separated according to species and sex. The temperature of the animal room varied between 15 and 17C. The animals were fed commercial animal food pellets of known composition, supplemented weekly with greens.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
TEST ORGANISMS:
- Number: 12
- Mean weight at study initiation: 114 g

ADMINISTRATION:
- Dose: 27.26 g/kg bw
- Route: oral (gavage) after fasting 22 to 24 hours. Feed was offered two hours after the treatment and water was available at all times.
- Vehicle: none (undiluted)
- Post dose observation period: 10 days


Doses:
27260 mg/kg (only dose tested; reported by von Oettingen to be the LD50.

Reference
van Oettingen, W.F. (1943). The aliphatic alcohols: Their toxicity and potential dangers in relation to their chemical constitution and their fate in metabolism. Public Health Bulletin 281, U.S. Public Health Service.
No. of animals per sex per dose:
12 females/dose level
Control animals:
not specified
Details on study design:
EXAMINATIONS: mortality, clinical signs, body weight (frequency not indicated), macroscopy in animals that died and selected survivors, histopathology of brain, heart, liver, spleen, stomach, intestine and kidney.
Statistics:
STATISTICAL METHOD: LD50 was calculated using logarithmic-probit graph paper

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
27 200 mg/kg bw
Based on:
test mat.
Mortality:
MORTALITY: not indicated



NECROPSY FINDINGS:
Clinical signs:
other: Muscle spasms and clonic convulsions prior to death. Survivors appeared normal within 2.5 hours after administration.
Gross pathology:
Hyperaemia of pylores and small intestine; congestion of the lungs; pale spleen; 3 animals showed hyperaemia of the cerebral meninges
Other findings:
No additional information provided.

Any other information on results incl. tables

No additional information available.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Results for natural and synthetic glycerine were comparable with an oral LD50 of 27,200 mg/kg.
Executive summary:

The acute oral LD50 of glycerine was examined. Results for natural and synthetic glycerine were comparable with an oral LD50 of 27,200 mg/kg.