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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Conducted according to generally accepted testing guidelines of the time. Basic data presented only.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981
Reference Type:
publication
Title:
Comparative acute and subchronic toxicity of ethylene glycol monopropyl ether and ethylene glycol monopropyl ether acetate
Author:
Katz, G.V., Krasavage, W.J. and Terhaar, C.J.
Year:
1984
Bibliographic source:
Environ. Health Perspect. 57:165-175

Materials and methods

Principles of method if other than guideline:
The study was conducted according to generally recognized procedures of the time. Equivalent to current methods.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(propyloxy)ethanol
EC Number:
220-548-6
EC Name:
2-(propyloxy)ethanol
Cas Number:
2807-30-9
Molecular formula:
C5H12O2
IUPAC Name:
2-(propyloxy)ethanol
Details on test material:
Test substance name: ethylene glycol monopropyl ether
Specific gravity: 0.913
Purity: >99.1%

Test animals

Species:
rat
Strain:
other: Charles River CD(BR)
Sex:
male
Details on test animals or test system and environmental conditions:
The test species were Charles River COBS, CD, BR male rats (150-200 g). All animals were quarantined and acclimated to the laboratory prior to assignment on the study. Animals were indiviually housed in suspended wire-bottomed cages. Water was available ad libitum. Food was ad libitum except for animals fasted for 16 to 20 hours prior to treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Administered undiluted using a glass syringe fitted with a polypropylene catheter.
Doses:
Ranged from 2.6 to 168 mM/kg bw
No. of animals per sex per dose:
5 in 5 dose groups
Control animals:
yes
Details on study design:
The acute oral LD50 values of test material were determined in separate groups of fasted and fed animals (150-200 g). Groups of 5 animals were given various doses of undiluted test material by gavage. Doses given were calculated on a mM/kg basis, and progressed by a factor of two (individual doses given were not listed). General appearance and activity, pharmacologic and toxicologic signs and mortality were checked twice daily (except on weekends and holidays).

The appearance of stools and urine was noted. Individual body weights were recorded prior to testing and at the end of the 2-week observation period. Animals that died and all survivors were necropsied and examined for gross pathology.
Statistics:
The LD50 value with its 95% confidence interval was calculated using the method of Thompson and Weil.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
3 089 mg/kg bw
Based on:
test mat.
95% CL:
2 340 - 4 077
Remarks on result:
other: Fasted rats. LD50: 29.70 (22.5- 39.2) mM/kg
Sex:
male
Dose descriptor:
LD50
Effect level:
6 178 mg/kg bw
Based on:
test mat.
95% CL:
4 680 - 8 154
Remarks on result:
other: Fed rats. LD50: 59.40 (45.0-78.4) mM/kg
Mortality:
Number of deaths at each dose not given.
Clinical signs:
other: Clinical signs of toxicity for both fed and fasted animals (numbers of animals affected were not stated) were inactivity, labored breathing, rapid respiration, anorexia, slight to moderate weakness, tremors, prostration and death. Animals that died exhibi
Gross pathology:
All survivors were necropsied and examined for gross pathology.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 value in fasted rats (and its confidence interval) was 29.70 (22.5-39.2) mM/kg, or 3089 (2340-4077) mg/kg. The LD50 value in fed rats (and its confidence interval) was 59.40 (45.0-78.4) mM/kg, or 6178 (4680-8154) mg/kg. The majority of deaths occurred within the first 3 days. The number of deaths at each dose was not stated.