2,3-epoxypropan-1-ol

Acute Toxicity: dermal

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

2,3-epoxypropan-1-ol

EC Number:

209-128-3

EC Name:

2,3-epoxypropan-1-ol

Cas Number:

556-52-5

Molecular formula:

C3H6O2

IUPAC Name:

(oxiran-2-yl)methanol

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 or test system 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:

other: Clinical signs were minimal following percutaneous absorption.

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.