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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 402 with GLP compliance.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl o-tolyl ether
EC Number:
EC Name:
2,3-epoxypropyl o-tolyl ether
Cas Number:
Molecular formula:
Constituent 2
Reference substance name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
Oxirane, 2-[(2-methylphenoxy)methyl]-
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Details on test animals or test system and environmental conditions:
Sprague-Dawley strain rats were supplied by Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K. At the start of the study the males weighed 202 - 223 gm, and the females 200 - 219 gm, and were approximately ten to fourteen weeks old. After a minimum acclimatisation period of at least five days the animals were placed on study.

The animals were housed individually in solid-floor polypropylene cages during the 24-hour exposure period. For the remainder of the study the animals were housed in groups of five by sex in polypropylene grid-floor cages suspended over trays lined with absorbent paper. 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, except the day brfore exposure.

The animal room was maintained at a temperature of 20 - 23°C and relative humidity of 53 - 69%. 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

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers to expose a skin area of approximately 5 cm x 4 cm. The calculated volume of the undiluted test substance, was applied uniformly to an area of shorn skin approximating to 10% of the total body surface area using a graduated syringe. A piece of aluminium foil measuring 7 cm x 4 cm was placed over the treatment area and occluded with a piece of self-adhesive bandage (HYPERTIE). The strapping was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24-hour exposure period.
Duration of exposure:
24 hours
2000 mg/Kg of body weight.
No. of animals per sex per dose:
Control animals:
Details on study design:
Shortly after dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the strapping and foil were carefully removed and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material. The animals were returned to group housing for the rest of the study.

Deaths and overt signs of toxicity were recorded , 1, 2 and 4 hours after dosing and subsequently at least once daily for 14 days. Individual bodyweights were recorded on the day of treatment (day 0) and on days seven and fourteen.

At the end of the studyperiod the animals were sacrificed by cervical dislocation and subjected to gross pathologic examination for any macroscopic abnormalities. This consisted of opening the abdominal and thoracic cavities and examining all major organs. The macroscopic appearance of abnormal organs if present was recorded.

No data

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Clinical signs:
other: None
Gross pathology:
No findings.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Migrated information Criteria used for interpretation of results: expert judgment
No adverse findings were made in the study. The rat acute dermal LD50 for the test substance is > 2000 mg/Kg of body weight. The test substance is non-toxic by the dermal route of exposure in the rat.
Executive summary:

The test substance, 2,3 -epoxypropyl o-tolyl ether was evaluated for acute dermal toxicity in the rat by an O.E.C.D. test guideline no. 402 study.No adverse findings were made in the study. The rat acute dermal LD50 for the test substance is > 2000 mg/Kg of body weight. The test substance is non-toxic by the dermal route of exposure in the rat.