2-(2-aminoethylamino)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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-aminoethylamino)ethanol

EC Number:

203-867-5

EC Name:

2-(2-aminoethylamino)ethanol

Cas Number:

111-41-1

Molecular formula:

C4H12N2O

IUPAC Name:

2-[(2-aminoethyl)amino]ethan-1-ol

Details on test material:

AEEA (2-(2-aminoethylamino)ethanol; substance 77/213),
degree of purity >98 %.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF-Breed, Wiga, Sulzfeld, Germany
- Age at study initiation: young adult
- Weight at study initiation: male: 145 g , female 127 g
- Diet: concentrated feed, Eggersmann, Rinteln/Weser, Germany, ad libitum
- Water : tap water ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: applied in olive oil and as neat substance

Details on dermal exposure:

TEST SITE
- Area of exposure: 11.5 cm² of the intact dorsal skin clipped 24 h before treatment
- coverage: 100 %
- Type of wrap if used: inert foil


REMOVAL OF TEST SUBSTANCE
- Washing: after 24 h with warm water

Duration of exposure:

24 h

Doses:

400 mg/kg bw (olive oil), 2000 mg/kg bw (neat)

No. of animals per sex per dose:

10/10 and 5/5 (males/females) for the 400 and 2000 mg/kg bw dose levels, respectively

Control animals:

no

Details on study design:

- Duration of observation period following administration: the animlas were observed for signs of toxicity during the 14-day observation ( after observation period animals were sacrified and necropsied)
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

- no mortality was seen at either dose level

Clinical signs:

other: - no signs of systemic toxicity were seen at either dose level

Gross pathology:

- during terminal necropsy pale kidneys were occasionally noted
- local skin irritation was noted 24 hours after application which led to scar formation within 14 days

Applicant's summary and conclusion

Executive summary:

In this acute dermal toxicity study groups of young adult Sprague Dawley rats were dermally exposed to AEEA (> 98 % a.i) at doses of 400 (in olive oil, 10/sex) and 2000 mg/kg bw (neat substance, 5/sex) for 24 hours to an area of 11.5 cm². Animals then were observed for 14 days. During terminal necropsy pale kidneys were occasionally noted and local skin irritation was noted 24 hours after application which led to scar formation within 14 days. No mortality and no signs of systemic toxicity were seen at either dose level.