2,3-epoxypropyl isopropyl ether

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

other: publication

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Sufficiently documented publication, scientifically reasonable method, testing performed on the registered substance itself.

Data source

Reference

Reference Type:

publication

Title:

The Toxicology of Glycidol and Some Glycidyl Ethers

Author:

Hine HC, Kodama JK, Wellington JS, Dunlap MK, Anderson HH

Year:

1956

Bibliographic source:

AMA Archives of Industrial Health. (Chicago, IL) 14,250,1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not applicable

GLP compliance:

no

Remarks:

conducted prior to GLP implementation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropyl glycidyl ether

IUPAC Name:

Isopropyl glycidyl ether

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Isopropyl glycidyl ether

Test animals

Species:

rabbit

Strain:

other: California Albino or New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: rabbitry at Point Reyes, Calif., or Gilroy laboratory, Calif.
- Weight at study initiation: 2 - 2.5 kg

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Healthy rabbits were clipped free of hair in a cylindrical swath from the shoulders to the hips 24 hours before use.
- Type of wrap if used: rubber sleeves; the rabbits were then wrapped in toweling to further minimize evaporation

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): graded doses, undiluted

Duration of exposure:

7 h

Doses:

graded doses

No. of animals per sex per dose:

no data

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 10 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

LD50 values were calculated by the method of Weil (Weil CS: Tables for Convenient Calculation of Median Effective Dose and Instructions in Their Use, Biometrics 8:249, 1952)

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

9 650 mg/kg bw

Based on:

test mat.

95% CL:

4 300 - 21 600

Mortality:

no details given

Clinical signs:

other: Signs of pharmacology activity were minimal following percutaneous absorption. When death occurred, it was usually within 17 hours, although occasionally delayed as long as 5 days. Varying degrees of skin irritation were noted.

Gross pathology:

no details given

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The studied was conducted scientifically reasonable with sufficient documentation similar to OECD 402, it was assessed with Klimisch 2. Hence, the results are sufficiently reliable to assess the acute dermal toxicity of isopropyl glycidyl ether in rats. An dermal LD50 was determined as 9650 mg/kg, which is above the limit value of 2000 mg/kg for classification according to Regulation 1272/2008, hence, the substance does not need to be classified as acute toxic and can be regarded as relatively harmless.

Executive summary:

In an acute dermal toxicity study similar to OECD 402, male California Albino or New Zealand White rabbits were dermally exposed to unchanged Isopropyl glycidyl ether for 7 hours at graded doses.  Animals then were observed for 10 days.

 

Dermal LD₅₀Males = 9650 mg/kg bw (95% C.I. 4300 - 21600)

 

Isopropyl glycidyl ether is of low Toxicity and does need to be classified as acute toxic according to Regulation 1272/2008.