Registration Dossier
Registration Dossier
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EC number: 932-235-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedure in accordance with national standard methods with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The eye reactions were scored according to Draize.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Undecan-1-ol
- EC Number:
- 203-970-5
- EC Name:
- Undecan-1-ol
- Cas Number:
- 112-42-5
- IUPAC Name:
- undecan-1-ol
- Details on test material:
- No detail available.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye
- Amount / concentration applied:
- Amount applied: 0.1 ml
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 7 days (Scored at 1, 24, 48, 72, 120 and 168 hours).
- Number of animals or in vitro replicates:
- 3M, 3F
- Details on study design:
- Eyes rinsed with warm isotonic solution after the 24 hour reading.
Results and discussion
In vivo
Results
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 13.3
- Max. score:
- 110
- Reversibility:
- fully reversible within: 120 hours
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hour) 10.7/110 combined cornea, iris and conjunctivae.
Any other information on results incl. tables
The individual scores were not reported only the calculated Draize scores.
DESCRIPTION OF LESIONS: There was immediate slight discomfort with slight redness and copious discharge at 10 minutes which developed to
slight to moderate redness with copious discharge at 1 hour. At 24 hours there was barely perceptible corneal dullness, the reaction of the iris to
light was sluggish in 2 rabbits (maximum score 1), conjunctival involvement (slight to moderate redness with whitish discharge) was observed in
all eyes at this time period.
REVERSIBILITY: After 24 hours there was a gradual improvement through to 120 hours when the iris and cornea appeared normal. All eyes
appeared completely normal by 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Undecyl alcohol is described as slightly irritating to the eye in this test. Under GHS criteria the results suggest classification as mild. Under EU criteria undecyl would not be considered irritant.
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