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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-08-01
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (corrosivity could be predicted from physico-chemical properties; intact and abraded skin tested)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other: acc. to US Fed. Reg. 244 (1972)
GLP compliance:
no

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-Butylamine [CAS No. 13360-63-9], not further specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3
- Air changes (per hr): 20
- Photoperiod (10 hrs dark / 14 hrs light):

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required
Amount / concentration applied:
undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
96 hrs
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 50 mm diameter
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after 4 hrs

SCORING SYSTEM: according to Draize (1959)

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Score:
5.9

Any other information on results incl. tables

The test substance produced severe erythema (score 4 ; readings at 4, 24, and 48 hrs)  and moderate edema (score 2; readings at 4, 24, and 48 hrs) in all animals. All test sites had become necrotic at the 4 hour reading.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The intact rabbit skin (six New Zealand White) had become necrotic after a 4-hour contact to Butylethylamine (neat, 500 mg under occlusive dressing) (Safepharm, 1980).