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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not stated
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
The toxicology of glycidol and some glycidyl ethers
Author:
Hine, C.H. et al.
Year:
1956
Bibliographic source:
Arch. Ind. Health 14, 250-264 (1956)
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: standard topical method for assessment of toxicity. Rabbits were tested for dermal reaction to the test substance following single exposure.
GLP compliance:
no
Remarks:
study conducted prior to adoption of GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glycidol
- Molecular weight (if other than submission substance): 74.05
- Physical state: Liquid

Test animals

Species:
rabbit
Strain:
other: California albino or New Zealand white
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Point Reyes California or Gilroy Laboratory, California.
- Age at study initiation: Not documented
- Weight at study initiation: 2.0 - 2.5kg
- Fasting period before study: Not documented
- Housing: Not documented
- Diet (e.g. ad libitum): Not documented
- Water (e.g. ad libitum): Not documented
- Acclimation period: Not documented

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not documented
- Humidity (%): Not documented
- Air changes (per hr): Not documented
- Photoperiod (hrs dark / hrs light): Not documented

IN-LIFE DATES: From: To: Not documented

Administration / exposure

Type of coverage:
other: under rubber sleeves, wrapped in towelling
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Cylindrical area from the shoulder to the hip.
- % coverage: Not documented
- Type of wrap if used: Rubber sleeve and wrapped in towelling

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not documented
- Time after start of exposure: Not documented

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not documented
- Concentration (if solution): Not documented
- Constant volume or concentration used: Not documented
- For solids, paste formed: Not documented
Duration of exposure:
7 hours
Doses:
Not documented
No. of animals per sex per dose:
Not documented
Control animals:
not specified
Details on study design:
Test animals were observed for 10 days post-treatment for signs of test-substance related effects.
Statistics:
Litchfield and Wilcoxon

Results and discussion

Preliminary study:
Not relevant
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 980 mg/kg bw
Remarks on result:
other: An LD 50 value is derived forthis assay despite no details being provided for the dose levels applied
Mortality:
When death occured it was usually within 17 hours, although occasionally delayed as long as 5 days.
Clinical signs:
Clinical signs were minimal following percutaneous absorption.
Body weight:
Not documented
Gross pathology:
No information provided
Other findings:
No additional information

Any other information on results incl. tables

No additional information

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
In this acute dermal toxicity study in rabbits the LD50 was 1980 mg/kg bw. Under the conditions of this experiment, the LD50of the test substance was determined to be 1980 mg/kg bw. Based on this result, the test substance should be classified as a Category IV toxicant according to Regulation EC No. 1272/2008 and should have the signal word "Warning" and the hazard statement H312: Harmful if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R21: Harmful in contact with the skin associated with it.
Executive summary:

In a study conducted by Hine et al (1956), the test substance Glycidol was tested for its ability to induce toxicity when applied cutaneously to the backs of male rabbits in a single application for an exposure of 7 hours. The test substance was applied undiluted to the freshly clipped backs of rabbits. The rabbits were then placed in a rubber sleeve, wrapped in towelling and held in multiple rabbit holder for the 7 hour exposure period.

When death occured it was usually within 17 hours, although occasionally delayed as long as 5 days. Minimal clinical signs were observed following exposure.

Under the conditions of this experiment, the LD50of the test substance was determined to be 1980 mg/kg bw. Based on this result, the test substance should be classified as a Category IV toxicant according to Regulation EC No. 1272/2008 and should have the signal word "Warning" and the hazard statement H312: Harmful if swallowed associated with it. According to Directive 67/548/EEC, the test substance should be classified as Harmful (Xn) and have the risk phrase R21: Harmful in contact with the skin associated with it.