Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1972-11-01
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Short communication only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
Method: other: BASF Screening
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-Ethylbutylamine CAS No. 13360-63-9], not further specified

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.05 mL
- Concentration: unchanged
Duration of treatment / exposure:
no data
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
no data
Details on study design:
Comment: not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: cornea peeling
Time point:
other: 1 hr
Remarks on result:
other: Severe edema and cornea opacity were also recorded
Irritation parameter:
other: purulence, bleeding
Time point:
other: 8 days
Reversibility:
not reversible
Remarks on result:
other: Severe edema and cornea opacity were also recorded

Any other information on results incl. tables

Severe edema, cornea opacity and peeling were produced, associated with  purulent necrosis. 

The effects persisted and aggravated throughout until  the end of the observation period (8 days).

Applicant's summary and conclusion

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

Ethylbutylamine (0.05 mL) caused severe edema, corneal opacity, and corneal peeling of the rabbit’s eye at 1 hour after treatment. The symptoms were irreversible and aggravated until the end of the observation on day 8. Strong purulence was seen on days 1 and 8 after treatment, along with bleeding on day 8 (BASF, 1972).

This information is suitable for assessment, and in line with expected effects deduced from the physic-chemical data. The effects are absolutely clear and the study is therefore assigned as key study despite the low reliability that is generally attributable to short communications.