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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

Constituent 1
Chemical structure
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).