Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 401 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Equal numbers of male and female Sprague-Dawley strain rats were supplied by Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K. At the start of the main study the males weighed 133 - 165g, and the females 120 - 142g, and were approximately five to eight weeks old. The animals were housed in groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding. With the exception of an overnight fast immediately before dosing and for approximately two hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet
No. 1, Special Diet Services Limited, Witham, Essex, U.K.) was allowed throughout the study.

The animal room was maintained at a temperature of 20 - 27°C and relative humidity of 42 - 74%. The rate of air exchange was approximately 15 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing.
Doses:
Limit dose, 5000 mg/kg of body weight
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All animals were dosed once only by gavage at 5000 mg/kg of body weight. Deaths and overt signs of toxicity were recorded , 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14, or at death. At the end of the study the animals were sacrificed and subjected to macroscopic examination. This consisted of opening the abdominal and examining all major organs. The macroscopic apperance of abnormal organs if present was recorded.
Statistics:
Not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were 3/10 mortalities at the Limit Dose of 5000 mg/kg of body weight.
Mortality:
3/10 at 5000 mg/kg
Clinical signs:
Common signs of toxicity noted were hunched posture, pilo-erection, lethargy, decreased respiratory rate, ptosis, ataxia or loss of righting reflex. Isolated signs of coma, emaciation or dehydration were also noted. All surviving animals appeared normal 3 - 4 days after treatment.
Body weight:
Surviving animals showed expected gain in bodyweight during the study period.
Gross pathology:
Abnormalities noted at necropsy of animals that died during the study were haemorrhagic or abnormally red lungs, patchy pallor of the liver, dark kidneys and haemorrhage of the small intestine. Necropsy of animals killed at the end of the study revealed isolated which foci approximately 1 mm x 1 mm over 25% of the non-glandular region of the stomach.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The acute oral median lethal dose (LD50) of the test material, 2,3-epoxypropyl o-tolyl ether in the Sprague-Dawley strain rat was found to be greater than 5000mg/kg bodyweight.
Executive summary:

An O.E.C.D. test guideline no. 401 Acute Oral Toxicity Study in the rat was conducted at the Limit Dose of 5000 mg/kg of body weight of the test substance, 2,3 -epoxypropyl o-tolyl ether. There were 3/10 mortalities at the Limit dose Therefore, the acute oral median lethal dose (LD50) of the test substance in the Sprague-Dawley strain rat is greater than 5000 mg/kg bodyweight.