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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Substance type: Commercial product
-Molecular weight: 144.25

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.10-3.28 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 50-58
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used as supplied
Duration of treatment / exposure:
Single treatment
Observation period (in vivo):
1hr and 24, 48 and 72 hours post exposure
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
ca. 0.83
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
ca. 0.63
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72h
Score:
ca. 1.42
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 1.06
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 172F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 172F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 172F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 172F
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 172F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 172F
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 172F
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 172F
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 172F
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 172F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 172F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 172F
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 176F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 176F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 176F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 176F
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 176F
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 176F
Time point:
72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 176F
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 176F
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 176F
Time point:
72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 176F
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 176F
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 176F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 159M
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 159M
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 159M
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 159M
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 159M
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 159M
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 159M
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 159M
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 159M
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 159M
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 159M
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 159M
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 4M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 4M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 4M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 4M
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 4M
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 4M
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 4M
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 4M
Time point:
48 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 4M
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 4M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 4M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 4M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 166F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 166F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 166F
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 166F
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 166F
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 166F
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 166F
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 166F
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 166F
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 166F
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 166F
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 166F
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 161M
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 161M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
other: Animal: 161M
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 161M
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 161M
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
other: Animal: 161M
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 161M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 161M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
other: Animal: 161M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 161M
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 161M
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
other: Animal: 161M
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
A dulling of the normal luster of the corneal surface was noted in two treated eyes one hour after treatment. Diffuse corneal opacity was noted in five treated eyes at the 24, 48, and 72 hour observation points. No other corneal effects were noted. Iridial irritation was noted in two treated eyes one hour after treatment and in five treated eyes at the 24-hours observation point. The effect persisted in four treated eyes at the 48-hour observation point and in two treated eyes at the 72-hour observation point. No other Iridial effects were noted. Minimal to moderate conjunctival irritation was noted in all treated eyes one and 24 hours after treatment and in five treated eyes at the 48 hour and 72 hour observation point. Petechial hemorrhage of the nictitating membrane was noted in one treated eye one hour after treatment. Treated eyes appeared normal by seven day observation point.

Any other information on results incl. tables

Individual animal scores for ocular irritation:

 Animal ID    1 hr  24 hr  48 hr  72 hr  7 days
 4 Male  Corneal Opacity  0 1  1  1  0 
   Iritis  0 1  0  0  0   
   Conjunctival Redness  1 2  2  1  0 
   Conjunctival Chemosis  1 2  1  1  0 
 166 Female  Corneal Opacity  0 1  1  1  0 
   Iritis  0 1  1  0  0 
   Conjunctival Redness  1 2  1  1  0 
   Conjunctival Chemosis  1 1  1  0  0 
 161 Male  Corneal Opacity  d  1 1 1  0 
   Iritis  1 1  1  1  0 
   Conjunctival Redness  2Pt  2 2  2  0 
   Conjunctival Chemosis  2 2  2  2  0 
 172 Female  Corneal Opacity  0 1  1  1  0 
   Iritis  0 1  1  0  0 
   Conjunctival Redness  1 2  1  1  0 
   Conjunctival Chemosis  1 1  1  0  0 
 176 Female  Corneal Opacity  d  1 1  1  0 
   Iritis  1 1  1  1  0 
   Conjunctival Redness  2 2  2  2  0 
   Conjunctival Chemosis  2 2  2  1  0 
 159 Male  Corneal Opacity  0 0  0  0   
   Iritis  0 0  0  0   
  Conjunctival Redness   1 1  0  0   
   Conjunctival Chemosis  1 0  0  0   

d = dulling of the normal lustre of the corneal surface

Pt = petechial haemeorrhage of the nictitating membrane

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Conclusions:
Branched alcohols, C8-C10, C-9 rich is irritating to eyes.
Executive summary:

In this study, 6 rabbits had their left eye instilled with 0.1 ml of isononanol and were evaluated for signs of eye irritation at 1, 24, 48 and 72 hours and 7 days post exposure according to the method of Draize.  Slight signs of irritation were noted within 1 hour post exposure, but these effects were resolved by the seven day observation point.  Mean eye irritation scores between 24 and 72 hours were: cornea score 0.83, iris score 0.63, and conjunctival redness 1.42. CAS number 68526 -84 -1 produced a mean corneal opacity score of≥1 in 5 of 6 individual animals.