2-aminoethyldiethylamine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Scientifically acceptable study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

according to BASF-internal standard

GLP compliance:

no

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-aminoethyldiethylamine

EC Number:

202-844-7

EC Name:

2-aminoethyldiethylamine

Cas Number:

100-36-7

Molecular formula:

C6H16N2

IUPAC Name:

N1,N1-Diethyl-1,2-ethanediamine

Test animals

Species:

rabbit

Strain:

Vienna White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mean body weights: male animals about 2.8 kg, female animals about 2.7 kg.
A standardized animal laboratory diet as well as tap water were available ad libitum.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

The product was applied undiluted in a dose of 200 mg/kg to the clipped areas (about 50 cm2) of the back and flanks.
Removal of fur from the dorsal and lateral parts of the trunk with an electric hair cutter about 15 to 24 hours before application. Only animals with a healthy and undamaged skin were used in the study.
The test substance was applied uniformly to an area of about 50 cm2. The treated area of skin was then covered with aluminum foil which was fixed with an adhesive tape. The dressing was removed after 24 hours; the test substance was then washed off with warm water or with a mixture of water and Lutrol, and the area was dried with wadding.

Duration of exposure:

24 h

Doses:

200 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Investigations:
Mortality within 8 days
Signs of systemic toxicity and of local irritation
Necropsy of the animals sacrificed with carbon dioxide at the end of the observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Mortality:

none

Clinical signs:

other: Signs of systemic toxicity: The animals showed a slight apathy up to 2 days after application. Signs of local irritation: 24 hours after application a necrosis was observed, which was not revesrible within 8 days after study start.

Gross pathology:

Sacrificed animals: nothing abnormal detected.

Applicant's summary and conclusion

Conclusions:

The acute dermal toxicity of 2-Amino-1-diaethyl-amino-aethan in Vienna white rabbits has been determined. This entailed the product being applied undiluted in a single dose of 200 mg/kg for 24 hours on clipped areas (about 50 cm2) of the back and flanks. The determination of the LD50 was based on the DOT guidelines, but no exact LD50 was established.

Executive summary:

The study was conducted according to an internal BASF method (BASF, 1978). Vienna White rabbits (5 males and 5 females) were dermally exposed to a single dose of 200 mg/kg bw of the undiluted test substance to the clipped skin of the back and flanks and covered by semi-occlusive dressing for 24 hours. Afterwards the test substance was removed by washing. The application area comprised at least a surface area of 50 cm². The animals were observed for 14 days. The following test substance-related effects were recorded during the course of the study: No mortality occurred. The animals showed a slight apathy up to 2 days after application. Local irritation was noticed, 24 hours after application a necrosis was observed, which was not reversible within 8 days after study start. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the study. As a conclusion, the LD50 value for acute dermal toxicity was found to be greater than 200 mg/kg bw (based on DOT guidelines). This acute dermal study is classified as acceptable.