Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not documented
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment. Increased dermal absorption probable due to application to scarified skin areas.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 Draize Test
GLP compliance:
no
Remarks:
completed prior to adoption of GLP principles

Test material

Constituent 1
Chemical structure
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-ylmethanol
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
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 - 3kg
- 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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Two sites shaved and two sites abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Not documented
Details on study design:
TEST SITE
- Area of exposure: Backs and flanks of each rabbit, with the shoulders and hips used as test sites.
- % coverage: Not documented
- Type of wrap if used: Occlusive - Three layers of gauze were secured over each test area with adhesive tape, with the undiluted test susbtance under the gauze. The animals were then wrapped in towels.

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

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
4.5
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Average score obtained after reading at 24 and 72 hours post-exposure
Irritant / corrosive response data:
The average score of 4.5 was judged to represent a moderately irritant response
Other effects:
Not documented

Any other information on results incl. tables

No additional information provided

Applicant's summary and conclusion

Interpretation of results:
no data
Remarks:
Migrated information A suitable classification cannot be derived from this data set Criteria used for interpretation of results: OECD GHS
Conclusions:
In this skin irritation study with rabbits glycidol was moderately irritating. Under the conditions of this test and due to the lack of information provided on the number of animals used and the individual responses, it was not possible to derive a classification according to Regulation EC No. 1272/2008 and Directive 67/548/EEC for the test substance. However, it is reported as being a moderate skin irritant.
Executive summary:

In a study conducted by Hine et al (1956), the test substance, Glycidol, was tested for its ability to cause skin irritation when applied to the hips and shoulders of male California albino or New Zealand White rabbits. The test areas were shaved 24 hours prior to exposure, with two test sites per animal abraded and two tests sites left intact. 0.5ml of the test substance was applied undiluted under 3 layers of gauze, secured with adhesive tape and the animals were then wrapped in towels, to form an occlusive dressing. The test substance was left in place for 24 hours. Following this, a reading was made at 24 hours, with a second reading made at 72 hours. The results were scored according to the Draize method. The overall mean irritation score after 24 and 72 hours was determined to be 4.5, with a maximum score of 8 recorded. Under the conditions of this test and due to the lack of information provided on the number of animals used and the individual responses, it was not possible to derive a classification according to Regulation EC No. 1272/2008 and Directive 67/548/EEC for the test substance. However, it is reported as being a moderate skin irritant.