Registration Dossier
Registration Dossier
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EC number: 236-415-0 | CAS number: 13360-63-9
Eye irritation
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:
- 1 972
- Report date:
- 1972
Materials and methods
- Principles of method if other than guideline:
- Method: other: BASF Screening
- GLP compliance:
- no
Test material
- 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
Constituent 1
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.
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