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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
other: publication
Adequacy of study:
key 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

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:
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.
Body weight:
no details given
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.