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Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
Reference substance name:
2-aminoethyldiethylamine
EC Number:
202-844-7
EC Name:
2-aminoethyldiethylamine
Cas Number:
100-36-7
Molecular formula:
C6H16N2
IUPAC Name:
(2-aminoethyl)diethylamine

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:
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.