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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:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Purity of the test material was not listed.

Data source

Reference
Reference Type:
publication
Title:
The comparative acute toxicity and primary irritancy of the monohexyl ethers of ethylene and diethylene glycol.
Author:
Ballantyne B.; Myers R. C.
Year:
1987
Bibliographic source:
Vet Human Tox 29:361-366

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): diethylene glycol monohexyl ether (DGHE)
- Physical state: Colorless liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were maintained on appropriate commercial diet and municipal water. Both were available adlibitum except during periods of restraining.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL / undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
14 days
Number of animals:
6
Details on study design:
Three male and three female New Zealand White rabbits were dosed with 0.5 mL of the test material. The dose was applied to the shaved, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material was applied to each of 6 rabbits for the 4-hr contact period. Skin reaction was scored, by the method of Draize, at one hour, one day, 2 days, 3 days, 7 days, and 14 days after dosing.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
A 4-hour application of 0.5 mL of test material to covered skin resulted in minor erythema on 3 of 6 rabbits. Two rabbits developed minor edema. After one day, minor erythema persisted on 3 animals. No edema remained. There was no erythema after two days, but desquamation was seen on day 7 post dosing.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A 4-hour application to covered rabbit skin under occlusive conditions produced minor irritation
Executive summary:

Three male and three female New Zealand White rabbits were dosed with 0.5 mL of Test material. The dose was applied to the clipped, intact skin under a gauze patch and is loosely covered with impervious sheeting. The test material was applied to each of 6 rabbits, which were restrained for the 4-hr contact period. Excess sample was removed after contact. Skin reaction was scored, by the method of Draize, at one hour, one day, 2 days, 3 days, 7 days, and 14 days after dosing. A 4-hour application of 0.5 mL of test material to covered skin resulted in minor erythema on 3 of 6 rabbits. Two rabbits developed minor edema. After one day, minor erythema persisted on 3 animals. No edema remained. There was no erythema after two days, desquamation was seen on day 7 post dosing.