Registration Dossier

Toxicological information

Eye irritation

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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:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Alcohols, C9-11-iso-, C10-rich
EC Number:
271-234-0
EC Name:
Alcohols, C9-11-iso-, C10-rich
Cas Number:
68526-85-2
Molecular formula:
CnH2n+1OH (n = 9 to 11)
IUPAC Name:
Alcohols, C9-11-iso-, C10-rich
Details on test material:
- Name of test material (as cited in study report): MRD-70-21
- Physical state: Clear liquid
- Analytical purity: Assumed to be 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.2-3.1 kg

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): Neat
- Applied into the conjunctival sac of the left eye of each rabbit
Duration of treatment / exposure:
- Eyes were held closed for 1 second following instillation of test material
Observation period (in vivo):
- 24, 48, and 72 hours and 4, 7, and 10 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
- Draize guidelines

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
0.5
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 through 72 h
Score:
1.54
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 through 72h
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 575
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 575
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 575
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 576
Time point:
24 h
Max. score:
4
Remarks on result:
other: Dull
Irritation parameter:
cornea opacity score
Basis:
animal: 576
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 576
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 577
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 577
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 577
Time point:
72 h
Max. score:
4
Remarks on result:
other: Dull
Irritation parameter:
cornea opacity score
Basis:
animal: 578
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 578
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 578
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 579
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 579
Time point:
48 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 579
Time point:
72 h
Score:
1
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 580
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 580
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: 580
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: 575
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 575
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 575
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 576
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 576
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 576
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 577
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 577
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 577
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 578
Time point:
24 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 578
Time point:
48 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 578
Time point:
72 h
Score:
1
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 579
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 579
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 579
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 580
Time point:
24 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 580
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: 580
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 575
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 575
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 575
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 576
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 576
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 576
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 577
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 577
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 577
Time point:
72 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 578
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 578
Time point:
48 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 578
Time point:
72 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 579
Time point:
24 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 579
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 579
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 580
Time point:
24 h
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 580
Time point:
48 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal: 580
Time point:
72 h
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal: 575
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 575
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 575
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 576
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 576
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 576
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 577
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 577
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 577
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 578
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 578
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 578
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 579
Time point:
24 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 579
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 579
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 580
Time point:
24 h
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 580
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal: 580
Time point:
72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
- Slight corneal opacity or dullness was observed in four animals.
- Slight iritis, chemosis, and discharge and slight to moderate redness were observed.
- The corneas in two animals appeared pitted at 24 hours.
Other effects:
- Immediately after instillation, all animals exhibited blinking and preening. One animal exhibited a very slight terminal body weight loss.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The eye irritation potential for isodecanol is minimal.
Executive summary:

Isodecanol was evaluated for acute eye irritation by a single instillation of 0.1 ml into the left eye of 6 rabbits.  Slight to moderate eye irritation was observed within 1 h post instillation and included slight corneal opacity, slight iritis, and slight to moderate conjunctival redness.  All signs of irritation were resolved by Day 7 post exposure. The eye irritation potential for isodecanol is minimal.  Mean eye irritation scores between 24 and 72 hours were: cornea score 0.5, iris score 0.5, conjunctival redness 1.54, and chemosis 0.17.