2-dimethylaminoethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 1991 - Jan 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed according OECD 402 guideline. GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EPA FR, Vol.50 188, September 27, 1985

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

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): 6398-36-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: 91-018
- Stability under test conditions: no apparent change in the physical characteristics of the test article during administration.
- Storage condition of test material: no data
- Other:specific gravity= 0.886 g/ml

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CAMM Research Lab Products, Wayne, New Jersey
- Weight at study initiation: 8-12 weeks
- Weight at study initiation: 1.930-2.315 kg
- 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 H.F., ad libitum,
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5 days

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

IN-LIFE DATES: From: 1991-11-01 To: 1991-11-15

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of trunk (clipped free of fur)
- % coverage: no data
- Type of wrap if used: rubber dam and an elastic bandage to retard evaporation

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

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3000 mg/kg
- Constant volume or concentration used: yes

VEHICLE not applicable

Duration of exposure:

24 hours

Doses:

3000 mg/kg

No. of animals per sex per dose:

10 (5 ♂ and 5 ♀)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: daily through 14 days, body weight: d0, d7 and d14
- Necropsy of survivors performed: yes

Statistics:

Statistics were calculated using Systat by Systat, Inc. Version 4.1, Evanston, IL.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 3 000 mg/kg bw

Remarks on result:

other: no mortality

Mortality:

- 0/10 animals died at the 3000 mg/kg dose level

Clinical signs:

other: - decreased activity, abnormal stance and abnormal gait - necrosis of the skin at the application sites

Gross pathology:

- severe irritation of underlying muscle at the application sites was observed in all animals at terminal necropsy

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the observations made in the Acute Exposure Dermal Toxicity Study in rabbits, the estimated acute dermal LD50 for 6398-36-1, Order #91-018, in males and females was determined to be greater than 3000 mg/kg.