2,2'-oxydi(ethylamine)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-01-09 - 1985-01-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Two animals are used, and only an exposure time of 4 hours is used. An occlusive dressing is used instead of a semi-occlusive dressing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

The study is performed similar to the initial test as described in OECD 404. However, two animals are used, and only an exposure time of 4 hours is used. An occlusive dressing is used instead of a semi-occlusive dressing.

GLP compliance:

not specified

Remarks:

Assumed to be GLP compliant as raw data is present and other studies of this lab are performed according to GLP principles.

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-oxydi(ethylamine)

EC Number:

220-395-5

EC Name:

2,2'-oxydi(ethylamine)

Cas Number:

2752-17-2

Molecular formula:

C4H12N2O

IUPAC Name:

2-(2-aminoethoxy)ethan-1-amine

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-22-1, Order #J-170
- Appearance: clear liquid
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Feeders are designed to reduce soiling, bridging and scattering.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site

Duration of treatment / exposure:

4 hours

Observation period:

Animals were observed at 4 and 48 hours after application of the test material.

Number of animals:

2 animals

Details on study design:

TEST SITE
- Area of exposure: trunk
- Type of wrap if used: Following the application of the test material, one-inch square patches were applied to the test site. The trunk of the animal was then wrapped with a rubber dam and an Ace bandage to retard evaporation.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the 4 hour exposure period, the wrappings were removed and the skin wiped to remove any remaining material.

SCORING SYSTEM: Initially, two rabbits will be administered the test article. The test will be considered positive if both animals exhibit a positive response and the study will be terminated. If only one animal or no animals exhibit a positive response, the test will be repeated with a different group of two rabbits. If one animal exhibits a positive response in the second group, the test article will be considered corrosive and the study will be terminated provided there was one positive response in Group I. If no positive reactions are observed in Group II, an additional group of two rabbits will be added and conclusions will be based on a total of six rabbits.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Skin necrosis

Basis:

animal #1

Time point:

other: 4h

Reversibility:

not specified

Remarks on result:

other: See 'Remarks'

Remarks:

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Results 2

Irritation parameter:

other: Skin necrosis

Basis:

animal #2

Time point:

other: 4h

Reversibility:

not specified

Remarks on result:

other: See 'Remarks'

Remarks:

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Results 3

Irritation parameter:

other: Skin necrosis

Basis:

animal #1

Time point:

48 h

Reversibility:

not specified

Remarks on result:

other: See 'Remarks'

Remarks:

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Results 4

Irritation parameter:

other: Skin necrosis

Basis:

animal #2

Time point:

48 h

Reversibility:

not specified

Remarks on result:

other: See 'Remarks'

Remarks:

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: See 'Remark'

Remarks:

Only skin necrosis is reported

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: See 'Remark'

Remarks:

Only skin necrosis is reported

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Remarks on result:

other: See 'Remarks'

Remarks:

Only skin necrosis is reported

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Remarks on result:

other: See 'Remarks'

Remarks:

Only skin necrosis is reported

Irritant / corrosive response data:

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Any other information on results incl. tables

Skin necrosis was visible in both rabbits at 4 hours and 48 hours after application of the test article.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the results of the DOT Corrosivity study in rabbits, the substance was considered to be corrosive to the skin. The test substance is classified as skin corrosive category 1B according to the criteria laid down in the CLP Regulation.