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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1956
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The back and flanks of rabbits (2 to 3 kg) were clipped 24 hours prior to use. The shoulders and hips were used as test sites, two areas on each animal being scarified and two intact. A patch consisting of three layers of gauze was secured over each area with adhesive tape, and 0.5 mL of the undiluted compound was introduced under the gauze. The rabbits were wrapped in towels and immobilized for 24 hours, after which the areas were examined and irritation scored noted. A second reading was made at 72 hours. The average of all readings was used as the basis for grading the compound.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Mol wt.: 130.21 g/mol
- Specific gravity: 0.9087
- Boiling point: 164
- Vapour pressure: 3.2
- Theoretical concentration at 25 C, ppm: 4,211
- Water solubility (% w/v): 2.0
- ppm in mg/L: 188.1

Test animals

Species:
rabbit
Strain:
other: California Albino or New Zealnad White males were used
Details on test animals and environmental conditions:
TEST ANIMALS
The rabbits were California Albino or New Zealand White males obtained from the rabbitry at Point Reyes, Calif., USA or the Gilroy Laboratory, Gilroy, USA. The weight was 2-3 kg.

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the undiluted compound
Duration of treatment / exposure:
24 h
Observation period:
Irriation was scored at 24 hours and 72 hours after start of the application
Number of animals:
n.a.
Details on study design:
The back and flanks of rabbits (2 to 3 kg) were clipped 24 hours prior to use. The shoulders and hips were used as test sites, two areas on each animal being scarified and two intact. A patch consisting of three layers of gauze was secured over each area with adhesive tape, and 0.5 mL of the undiluted compound was introduced under the gauze. The rabbits were wrapped in towels and immobilized for 24 hours, after which the areas were examined and irritation scored noted. A second reading was made at 72 hours. The average of all readings was used as the basis for grading the compound.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/72 hours
Score:
2.8
Max. score:
4
Reversibility:
not specified
Remarks on result:
other:
Remarks:
Irritation scores were only recorded at 24 and 72 hours
Irritant / corrosive response data:
The maximum injury score for erythema (4) was obtained in some rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In this study, under the given conditions, the test item showed mild irritant effects.
Executive summary:

In a primary dermal irritation study, New Zealand White rabbits were exposed to 0.5 mL of undiluted n-butyl glycidyl ether (BGE) for 24 h under occlusive conditions.Scoring of skin irriation was done according to Draize at 24 hours and 72 hours after application of the test material. An average skin irritation score of 2.8 was identified in the publication by Hine et al., 1956.