Registration Dossier
Registration Dossier
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EC number: 203-875-9 | CAS number: 111-49-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only secondary literature available.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- secondary source
- Title:
- Revised Summaries
- Author:
- Invista S.à.r.I.
- Year:
- 2 009
- Bibliographic source:
- US EPA High production volume (HPV) Challenge Program, 2009; http://www.epa.gov/chemrtk/pubs/summaries/hexmthln/c13912tc.htm
Materials and methods
- Principles of method if other than guideline:
- eye irritation test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Perhydroazepine
- EC Number:
- 203-875-9
- EC Name:
- Perhydroazepine
- Cas Number:
- 111-49-9
- Molecular formula:
- C6H13N
- IUPAC Name:
- azepane
- Details on test material:
- - Name of test material (as cited in study report): Hexamethyleneimine
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 3/6 animals: treated eye was washed with water beginning 20-30 seconds after application for 60 seconds.
3/6 animals: no washing performed - Observation period (in vivo):
- The study was terminated after 24 h observation and the rabbits were killed.
- Number of animals or in vitro replicates:
- 6 male
- Details on study design:
- TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- 24 h after application all 6 animals exhibited blanching of the nictitating membrane and eschar of the eyelids. in addition, 3 of the rabbits had blanching of the conjunctiva, while the conjunctiva of the remaining rabbits was not visible due to eschar on the eyelids.The iris of all rabbits was unscorable due to severity of the opacity. After 24 h the study was terminated.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the applied test conditions the test substance was highly corrosive to the eyes of all six animals.
- Executive summary:
An eye irritation test was performed with six rabbits. The animals were exposed to 0.1 ml of test substance . 24 h after application all 6 animals exhibited blanching of the nictitating membrane and eschar of the eyelids. In addition, 3 of the rabbits had blanching of the conjunctiva, while the conjunctiva of the remaining rabbits was not visible due to eschar on the eyelids.The iris of all rabbits was unscorable due to severity of the opacity. After 24 h the study was terminated due to the strong corrosive effects.
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