Bis(2-chloroethyl) ether

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Version / remarks:

Title 49, Code of Federal Regulation, 173.1200, Appendix A, Method of Testing Corrosion to the Skin

Deviations:

not specified

Principles of method if other than guideline:

The study was conducted prior to development of OECD guidelines. It is broadly comparable with OECD 404 however 72 hour observations were not performed. The Draize (1965) method was followed.

GLP compliance:

no

Test material

Test material information

Constituent 1

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: dichloroethylether, Lot BA. 97
- Expiration date of the lot/batch: not stated

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kuiper's Rabbitry, Gary, IN
- Age at study initiation: 14 weeks
- Weight at study initiation: 2151 - 2425 g males; 2415 - 2893 g females
- Housing: individually in screen bottom cages
- Diet (e.g. ad libitum): commercial laboratory diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled, values not stated
- Humidity (%): humidity controlled, values not stated

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

48 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Area of exposure: 1 x 1 inch
- Type of wrap if used: 1 x 1 inch gauze patch secured with tape, overwrapped with Saran wrap (plastic film) and secured in place with elastoplast tape. The rabbits were fitted with elizabethan collars during the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application sites were washed with water immediately after the first reading

OBSERVATION TIME POINTS
- 4 hours (at removal of dressings), 24 hours and 48 hours

SCORING SYSTEM:
- Method of calculation: Draize scoring method for erythema and oedema formation (values 0 to 4)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 4 hours

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

other: 4 hours

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

24 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

6 animals

Time point:

48 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

There were no signs of irritation in any animal at any time point

Other effects:

No other effects reported

Any other information on results incl. tables

There were no signs of irritation in any animal at any time point; scores for erythema and oedema were 0 in all instances.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

There were no signs of irritation or corrosivity in any animal therefore classification according to CLP is not proposed.

Executive summary:

An older skin irritation study in the rabbit is available for Bis(2 -chloroethyl) ether. The study was conducted prior to development of GLP and OECD test guidelines, however the method of Draize (1965) was followed and therefore the methodology is considered to be acceptable. Three male and three female New Zealand White rabbits were prepared by clipping the skin on the back 24 hours prior to exposure. A quantity of 0.5 mL test substance (undiluted) was applied to the clipped skin and held in place using an occlusive dressing for 4 hours. The test sites were evaluated for signs of irritation and corrosion at dressing removal and 24 and 48 hours later. The test sites were washed with water after the first observation. There were no signs of irritation at any time point in any animal; scores for erythema and oedema were 0. It was concluded that the test substance is not a skin irritant.