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Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, acceptable with restrictions (The study was performed before the establishment of GLP and OECD guidelines.)

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The toxicology of Glycidol and some Glycidyl Ethers.
Author:
Hine CH et al.
Year:
1956
Bibliographic source:
Report, Department of Pharmacology and Experimental Therapeutics, University of California School of Medicine, San Francisco. Cited in OECD SIDS (SIAM 25, October 2007, Helsinki)
Reference Type:
publication
Title:
The toxicology of Glycidol and some Glycidyl Ethers.
Author:
Hine CH, Kodama JK, Wellington JS, Dunlap MK and Anderson HH
Year:
1956
Bibliographic source:
A.M.A. Archives of Industrial Health. 14: 250-264. Cited in OECD SIDS (SIAM 25, October 2007, Helsinki)
Reference Type:
publication
Title:
The toxicology of glycol and some glycidyl ethers.
Author:
Shell Chemical Company
Year:
1956
Bibliographic source:
TSCATS, OTS0523687, New Doc ID 40-5640496, Date produced 3/18/56.

Materials and methods

Principles of method if other than guideline:
Male rats (n = 6) were dosed at 1300, 1600, 1900 and 2300 mg/kg bw Alyl glycidyl ether (AGE) by intragastric intubation once. Clinial signs and mortalities were observed for 10 days. At the end of observation period, all animals were sacrificed and necropsy was performed.
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Allyl 2,3-epoxypropyl ether
EC Number:
203-442-4
EC Name:
Allyl 2,3-epoxypropyl ether
Cas Number:
106-92-3
Molecular formula:
C6H10O2
IUPAC Name:
2-[(prop-2-en-1-yloxy)methyl]oxirane
Details on test material:
- Name of test material (as cited in study report): Allyl Glycidyl Ether

Test animals

Species:
rat
Strain:
Long-Evans
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Simonson laboratory in Gilroy, California
- Weight at study initiation: 89-150 g
- Fasting period before study: overnight prior to dosing
- Housing: 5-6 per cage
- Diet (e.g. ad libitum): standard laboratory pellets

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% in propylene glycol
Doses:
1300, 1600, 1900 and 2300 mg/kg b.w.
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 10 days
- Frequency of observations and weighing: not reported
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology
Statistics:
Litchfield and Wilcoxon (J. Pharmacol. & Exper. Therap. 98: 101-103, 1949)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 600 mg/kg bw
95% CL:
1 390 - 1 840
Mortality:
0/6, 3/6, 5/6, 6/6 at the dose levels of 1300, 1600, 1900 and 2300 mg/kg bw, respectively. The death occured at 4-19, 2-27, 3-20 hours at the dose levels of 1300, 1600, 1900 and 2300 mg/kg bw, respectively.
Clinical signs:
other: Within 10 minutes the rats showed signs of distress such as slight lacrimation, mussed fur, restlessness and slight unsteadiness. Slight to moderate depression and dyspnea were usually seen between 15 and 90 minutes after dosing. Most survivors recovered
Gross pathology:
Rats that died showed diffuse inflammation of the lungs, slight to moderate irritation of gastroenteric tract with fluid distention and petechial hemorrhages in the stomach. Spleen and kidneys were pale and discoloured. Rats sacrified 10 days after exposure showed hypotonicity of the enteric tract and extensive adhesions of the stomach walls to adjacent tissues.
Other findings:
- Histopathology: Tissues of 7 rats showing gross changes were examined microscopically. With the exception of one liver, which showed focal areas of necrosis, all other organs were judged to be normal.

Applicant's summary and conclusion