Butyl(ethyl)amine

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979-06-01

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted standards with acceptable restrictions (limited performance and documentation)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

Method: other: single-dose test (adjusted to DOT guidelines)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl(ethyl)amine

EC Number:

236-415-0

EC Name:

Butyl(ethyl)amine

Cas Number:

13360-63-9

Molecular formula:

C6H15N

IUPAC Name:

butyl(ethyl)amine

Details on test material:

- Name of test material (as cited in study report): N-Ethyl-N-n-Butylamine [CAS No. 13360-63-9], not further specified

Test animals

Species:

rabbit

Strain:

other: white Vienna

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: males 2.5 kg; females 2.2 kg
- Fasting period before study:
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: none

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 cm²
- Type of wrap if used: aluminium foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 200 mg/kg
- Concentration (if solution): neat
- Constant volume or concentration used: yes

VEHICLE
no vehicle used

Duration of exposure:

24 hours

Doses:

200 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: observation at 1 hr, 1, 2, and 8 days after treatment
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 200 mg/kg bw

Any other information on results incl. tables

No mortality in any sex. No signs of intoxication. No macroscopic pathological findings of inner organs.
Local effects: soft skin necrosis after 1 day, full thickness necrosis after 8 days

Applicant's summary and conclusion

Executive summary:

The acute dermal toxicity of butylethylamine was tested in a limit dose study that was designed to meet the DOT regulation. Five male and female rabbits received 200 mg/kg bw on the shaved intact skin (occlusive, 24 hr) and were observed for 8 days. There were no clinical signs of toxicity or deaths. Local skin irritation was seen, along with full thickness necrosis at day 8 after treatment. Thus, the dermal LD50 was >200 mg/kg bw in this study (BASF, 1979).