2-[2-(dimethylamino)ethoxy]ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD guideline study with acceptable restrictions (no test substance purity given). Acceptable, well documented report which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 1981)

Deviations:

yes

Remarks:

compared to OECD TG 404 (2002): observation period 72 h instead of 14 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[2-(dimethylamino)ethoxy]ethanol

EC Number:

216-940-1

EC Name:

2-[2-(dimethylamino)ethoxy]ethanol

Cas Number:

1704-62-7

Molecular formula:

C6H15NO2

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): Lupragen N 107
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 2.99, 2.64 kg (males); 2.87 kg (female)
- Housing: 1 animal per cage
- Diet: KLIBA 341, 4 mm; Klingentalmuehle AG, CH, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped at least 15 h before application

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Test patches were secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize Scoring System

READINGS
30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 72 h after the beginning of application

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: necrosis

Basis:

mean

Time point:

72 h

Reversibility:

not reversible

Remarks on result:

other: All three animals showed full thickness necrosis at the end of the observation period.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.4

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Any other information on results incl. tables

Results skin irritation: (animal 1/2/3)

Reading:	Erythema	Edema	Symptoms
4 h	2/3/3	2/2/2	-/HE/HE
24 h	4/4/4	2/2/2	N/N/N
48 h	4/4/4	1/1/2	N/N/N
72 h	4/4/4	1/1/1	TN+/TN+/TN+

HE: hemorrhage

N: necrosis.

TN: Full thickness necrosis.

+: findings confirmed by gross pathology examination.

After 4 h exposure hemorrhages were seen and after 24 necrosis occured in all three animals. At the end of the observation period at 72 h full thickness necrosis was observed in all three animals. Full thickness necrosis was confirmed by gross-pathological examination.

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria