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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1998
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

Constituent 1
Chemical structure
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

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.