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EC number: 203-852-3 | CAS number: 111-27-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- other: Techincal Report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Hexan-1-ol
- EC Number:
- 203-852-3
- EC Name:
- Hexan-1-ol
- Cas Number:
- 111-27-3
- Molecular formula:
- C6H14O
- IUPAC Name:
- hexan-1-ol
- Test material form:
- not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- None included in report.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): 100%, undiluted - Duration of treatment / exposure:
- The eye was not rinsed of the test substance, the first observations were made at 1h and 4h.
- Observation period (in vivo):
- 1,h, 4h, 24, 48, 72 hours, 7, 10, 14 and 21 days (assessments made until the test eye for each animal showed complete reversal to
normal up to 21 days). - Number of animals or in vitro replicates:
- 4, sex unspecified
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed
SCORING SYSTEM: Grading Scale for Eye Irritation Effects, OECD, 1987. Grading Scale and Multiplication Factors, Draize et al. 1944.
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- The study was included as part of a data base of in vivo eye irritation results. All studies were conducted to OECD guideline 405 under GLP.
Any other information on results incl. tables
AVERAGE SCORE (24+48+72 hour)
- Cornea: Individual 3, 2, 2, 1.7 Mean 2.2
- Iris: Individual 2, 1, 1, 1.3 Mean 1.3
- Conjunctivae (Redness): Individual 3, 2, 3, 2.7 Mean 2.7
- Conjunctivae (Chemosis): Individual 3, 2, 3, 2 Mean 2.5
- Overall irritation score: MMAS (modified maximum score 64.8)
REVERSIBILITY: Effects on the cornea and iris had reversed by 7 days, redness and/or chemosis persisted to 7 days in one rabbits, 10 days in 2
animals and 14 days in the final rabbit, all scores were 0 by day 21.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Category 2 according to Regulation (EC) No 1272/2008.
- Conclusions:
- IIn the in vivo eye irritation study, conducted according to OECD Test Guideline 405 and in compliance with GLP, hexan-1-ol was concluded to be irritating to eyes. Hexan-1-ol is classified for eye irritation Category 2A according to GHS criteria and Category 2 according to Regulation (EC) No 1272/2008 based on individual mean 24+48+72-hour scores in at least 2 test animals of => 1 for corneal opacity and iritis and => 2 in at least 2 test animals for conjunctival chemosis and redness. Only 1 animal scored => 3 for corneal opacity or => 1.5 for iritis.
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