2-(2-aminoethoxy)ethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

12 May 1981

Deviations:

yes

Remarks:

purity not reported

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EPA Federal Register, Vol. 50 188

Version / remarks:

27 September 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-(2-aminoethoxy)ethanol

EC Number:

213-195-4

EC Name:

2-(2-aminoethoxy)ethanol

Cas Number:

929-06-6

Molecular formula:

C4H11NO2

IUPAC Name:

2-(2-aminoethoxy)ethan-1-ol

Specific details on test material used for the study:

- Name of test material (as cited in study report): 6398-21-1
- Physical state: clear, colorless liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: 90-013
- 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: gravity: 1.06g/ml; pH=12 (litmus paper)

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hare-Marland, Hewitt, New Jersey
- Age at study initiation: young adult
- Weight at study initiation: 2.119-2.764 kg
- 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 Animal Resources, National Research Council
- Diet (e.g. ad libitum): Purina Rabbit Ration H.F., ad libitum
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: min. 5d


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

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)
- Type of wrap if used: rubber dam and an elastic bandage


REMOVAL OF TEST SUBSTANCE: no data


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

Duration of exposure:

24h

Doses:

3000 mg/kg

No. of animals per sex per dose:

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 14d, body weight recorded at d0, d7 and d14
- Necropsy of survivors performed: YES
- Other examinations performed: clinical signs, body weight

Statistics:

Not applicable.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

3 000 mg/kg bw

Mortality:

No mortality observed during study.

Clinical signs:

other: Days 1 and 2: 10/10 animals:decreased activity, abnormal stance& gait. Days 3 up to 14 no signs in all observed animals. Day 1: 1/10 animal:diarrhea. Days 3 up to 14 no signs in all observed animals. Day 2: 10/10 animals poor grooming. Days 3 up to 14 no

Gross pathology:

Terminal necropsy of the animals revealed severe irritation and/or yellow discoloration of the underlying muscle tissue at the application site, necrotic or discolored yellow fascia at the application site, mottled lungs and pale kidneys.

Other findings:

no other data

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 > 3000mg/kg.

Executive summary:

In a Limit Test, one group of 10 rabbits (5 males and 5 females) was dermally administered the test article at 3000 mg/kg. Clinical signs observed during the study included decreased activity, abnormal stance, abnormal gait, diarrhea, poor groo of fur surrounding the application site were observed. Necrosis and sloughing of the skin at application site, bilateral alopecia and a clear exudate from necrotic areas were also observed during the study. Terminal necropsy of the animals revealed severe irritation and/or yellow discoloration of the underlying muscle tissue at the application site, necrotic or discolored yellow fascia at the application site, mottled lungs and pale kidneys. Based on the observation made in the Acute Exposure Dermal Toxicity Study in rabbits, the estimated acute dermal LD50 was determined to be greater than 3000 mg/kg.