2-[(2-[2-(dimethylamino)ethoxy]ethyl)methylamino]ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1984-04-05 to 1984-04-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

No major deviations identified

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method was performed to satisfy DOT corrosivity classification requirements. The test substance was applied for four hours under occluded conditions for four hours and observed after four and 48 hours for positive responses

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-22-20
- Physical state: Clear liquid
- Lot/batch No.: Order # J-175
- Stability under test conditions: There was no apparent change in the physical state of the test material during administration
- Other: The purity of the test material is the responsibility of the sponsor

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, USA
- Weight at study initiation: 2 - 3 kg
- Housing: 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: Wayne Rabbit Ration, ad libitum
- Water: Fresh tap water, fit for human consumption, ad libitum
- Acclimation period: 5 days

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

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

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:

48 hours

Number of animals:

2 per dose group

Details on study design:

TEST SITE
- Type of wrap if used: test area was covered with one inch square patches; trunk of animal wrapped with a rubber dam and an Ace bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was wiped to remove any remaining material
- Time after start of exposure: 4 hours

SCORING SYSTEM: Corrosion will be considered to have resulted if the substance in contact with the rabbit skin has caused destruction or irreversible alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction is considered to have occurred if, at any of the readings, there is ulceration or necrosis. Tissue destruction does not include merely sloughing of the epidermis or erythema, edema or fissuring.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks on result:

other: slight to well defined erythema were observed during the study

Results 2

Irritation parameter:

edema score

Remarks on result:

other: Slight to moderate edema were observed during the study

Irritant / corrosive response data:

No signs of skin necrosis were visible at any observation period.

Any other information on results incl. tables

Slight to well defined erythema and slight to moderate edema were observed during the study. No signs of skin necrosis were visible at any observation period. The test substance was not considered corrosive based on results of the DOT corrosivity study in rabbits.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Based upon the results of this study, the test substance was not considered to be corrosive.

Executive summary:

The test substance was applied to an intact skin site on each of six rabbits (three males and three females). The test substance was kept in contact with the skin for four hours. Animals were observed at 4 and 48 hours after treatment. Slight to well defined erythema and slight to moderate edema were observed during the study. No signs of skin necrosis were visible at any observation period. Based on the results of DOT corrosivity study in rabbits, the substance was not considered to be corrosive.