2-dimethylaminoethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed according to OECD 404 guideline and in compliance with GLP Regulations. There were no significant deviations from the guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-dimethylaminoethanol

EC Number:

203-542-8

EC Name:

2-dimethylaminoethanol

Cas Number:

108-01-0

Molecular formula:

C4H11NO

IUPAC Name:

2-(dimethylamino)ethanol

Details on test material:

- Name of test material (as cited in study report): 6389-36-1
- Physical state: clear,colorless liquid
- Lot/batch No.: # 91-018
- Purity = responsibility of the Sponsor
- Stability under test conditions: no apparent change in the physical state of the test article during administration
- pH=8 (litmus paper)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Age at study initiation: adult
- Weight at study initiation: 1.941-2.365kg
- Housing: individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of.Laboratory Animal Resources, National Research Council
- Diet (e.g. ad libitum): Purina Rabbit Chow HF, ad libitum
- Water (e.g. ad libitum): Fresh tap water, ad libitum
- Acclimation period: min. 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (63-73°)
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12h light, 12h dark

IN-LIFE DATES: From: Oct 15, 1991 To: Oct 29, 1991

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

unchanged (no vehicle)

Controls:

other: OECD 404: untreated area of the test animal serves as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site, 3 sites per animal

Duration of treatment / exposure:

- 4 h (upper dorsal site-intact)
- 24h (lower dorsal site-intact and abraded)

Observation period:

Upper dorsal site (intact): 14 days
Lower dorsal site (intact and abraded): 14 days

Number of animals:

6 (3 male and 3 female)

Details on study design:

TEST SITE
- Area of exposure: trunk (lower and upper), clipped free of fur
- Type of wrap if used: rubber dam and an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with water and gauze
- Time after start of exposure: 4 and 24h

SCORING SYSTEM: observation
Draize Evaluation of Dermal Irritation, Primary Irritation Index and Modified Primary Irritation Index

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Score:

8

Max. score:

8

Remarks on result:

other: severe dermal irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6/6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: intact site: severe erythema , necrosis

Remarks:

Times of observation included also: 30-60min, and daily up to 14d

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

6/6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: intact site: severe edema

Remarks:

Times of observations included also 30-60min, and daily up to 14d

Results 4

Irritation parameter:

erythema score

Basis:

mean

Remarks:

6&6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14d observation

Remarks on result:

other: no difference between intact and abraded site, severe erythema, necrosis

Remarks:

Times of observations included also daily up to 14d

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

6&6

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

14 d observation

Remarks on result:

other: no difference between intact and abraded site :severe edema

Remarks:

Times of observations included also daily up to 14d

Irritant / corrosive response data:

Modified PDII=8 (severe dermal irritation).

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The test article was considered to be a severe dermal irritant (PDII and Modified PDII=8).

Executive summary:

New Zealand White rabbits were used to assess the irritating potential of DMAE. The undiluted test material was administered occlusive to the abraded and non-abraded skin of the animals for 4 and 24 hours. There were no differences between intact and abraded sites. The test material caused severe erythema with necrosis which were not reversible within 14 days of observation.