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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication. No GLP, conducted methods not according to todays standards. However, this publication is key data since the lowest oral LD50 (guinea pig) was determined.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
The single dose toxicity of some glycols and derivatives.
Author:
Smyth HF, Seaton J, Fischer L
Year:
1941
Bibliographic source:
J Int Hyg Toxicol 23: 259-268
Reference Type:
publication
Title:
The calculation of the dosage-mortality curve.
Author:
Bliss, C. I.
Year:
1935
Bibliographic source:
Ann. Appl. Biol., 22: 134-167
Reference Type:
publication
Title:
The determination of the dosage-mortality curve from small numbers.
Author:
Bliss, C. I.
Year:
1938
Bibliographic source:
Quart. J. Pharm. & Pharmacol., 11: 192-216

Materials and methods

Principles of method if other than guideline:
Method: other: Acute oral toxicity
GLP compliance:
no
Test type:
other: acute oral toxicity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
test substance as stated in publication: "Ethylene glycol monoethyl ether"
commercial grade; dissolved in water at max. 50 % for administration

Test animals

Species:
other: rat, guinea pig
Strain:
other: albino Wistar (rats); strain not specified (guinea pigs)
Sex:
male/female
Details on test animals and environmental conditions:
animal breeders: commercial breeders; source of rats did not change throughout whole study
weight of animals at point of administration: 90-120 g (rats) and 250-300 g (guinea pigs)
developmental stage of rats and guinea pigs: about the same

Administration / exposure

Vehicle:
water
Details on oral exposure:
administered by stomach tube in single doses
Doses:
2510-3590 mg/kg bw , slope 6160 (rats); 1220 - 1600 mg/kg bw, slope 7750 (guinea pigs)
No. of animals per sex per dose:
10 (per dose; only general information about sex was given, not specified for dosage groups)

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 000 mg/kg bw
Remarks on result:
other: rat
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 400 mg/kg bw
Remarks on result:
other: guinea pig

Any other information on results incl. tables

Diet of animals: Purina chows, supplemented by fresh vegetables; water freely available. Diet given in the afternoon and the doses administered the following morning (in most cases).

Most deaths occurred during first two days but all deaths within 14 days of administration were used for LD50 calculation. Animals whose death was inconsistent with the indications from others was autopsied, and if found to be infected it was not included in the calculations. Tissues not studied microscopically.

Applicant's summary and conclusion

Conclusions:
The test substance 2-ethoxyethanol was administered orally to rats and guinea pigs. The determined LD50 values were 3000 mg/kg and 1400 mg/kg, respectively.