2-(2-hexyloxyethoxy)ethanol

Skin irritation / corrosion

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

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-hexyloxyethoxy)ethanol

EC Number:

203-988-3

EC Name:

2-(2-hexyloxyethoxy)ethanol

Cas Number:

112-59-4

Molecular formula:

C10H22O3

IUPAC Name:

2-[2-(hexyloxy)ethoxy]ethan-1-ol

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 2

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.