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

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970
Reference Type:
publication
Title:
Acute toxicity of a homologous series of branched chain primary alcohols
Author:
Scala RA and Burtis EG
Year:
1973
Bibliographic source:
Am Ind Hyg Assoc J 34:493-499

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MDR-70-20
- Physical state: liquid, clear

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:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
24, 48 and 72 hours and 4, 7 and 10 days post instillation.
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
- Draize score for ocular irritation

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 569
Time point:
24 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 569
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 569
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 569
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 570
Time point:
24 h
Score:
0
Remarks on result:
other: Dull
Irritation parameter:
cornea opacity score
Basis:
animal: 570
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 570
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 570
Time point:
24/48/72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 571
Time point:
24 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 571
Time point:
48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 571
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: 571
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 572
Time point:
24 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 572
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 572
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 572
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 573
Time point:
24 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 573
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 573
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 573
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: 574
Time point:
24 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 574
Time point:
48 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 574
Time point:
72 h
Score:
1
Irritation parameter:
cornea opacity score
Basis:
animal: 574
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 569
Time point:
24 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 569
Time point:
48 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 569
Time point:
72 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 569
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 570
Time point:
24 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 570
Time point:
48 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 570
Time point:
72 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 570
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 571
Time point:
24 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 571
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 571
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 571
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 572
Time point:
24 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 572
Time point:
48 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 572
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 572
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 573
Time point:
24 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 573
Time point:
48 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 573
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 573
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal: 574
Time point:
24 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 574
Time point:
48 h
Score:
1
Irritation parameter:
iris score
Basis:
animal: 574
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal: 574
Time point:
24/48/72 h
Score:
0.67
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 569
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 569
Time point:
48 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 569
Time point:
72 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 569
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 569
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 569
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 569
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 569
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 570
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 570
Time point:
48 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 570
Time point:
72 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 570
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 570
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 570
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 570
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 570
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 571
Time point:
24 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 571
Time point:
48 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 571
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: 571
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 571
Time point:
24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 571
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 571
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 571
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 572
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 572
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 572
Time point:
72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 572
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 572
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 572
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 572
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 572
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 573
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 573
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 573
Time point:
72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 573
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 573
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 573
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 573
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 573
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: 574
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: 574
Time point:
48 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 574
Time point:
72 h
Score:
1
Irritation parameter:
conjunctivae score
Basis:
animal: 574
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: 574
Time point:
24 h
Score:
1
Irritation parameter:
chemosis score
Basis:
animal: 574
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 574
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: 574
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Corneal dullness or slight opacity was seen in 5 animals through 72 hours or Day 4. Slight iritis and slight to moderate redness, chemosis, and discharge were observed. Fluorescein staining at Day 7 confirmed the absence of corneal damage in all eyes.

Any other information on results incl. tables

Table 1:

 

 

Animal number

Hours

 

                   Days

 

Observation 

1

4

24

48

72

24-78 

   4

  7

Cornea

average

569

Opacity

Dull

Dull

1

1

1

1.00

1

0

569

Area Involved*

3

4

4

4

0

570

Opacity

0

Dull

Dull

1

1

0.66

0

0

570

Area Involved*

0

1

1

0

0

571

Opacity

0

0

0

0

0

0.00

0

0

571

Area Involved*

0

0

0

0

0

0

0

572

Opacity

1

1

1

1

1

1.00

1

0

572

Area Involved*

4

4

4

4

4

4

0

573

Opacity

1

1

1

1

1

1.00

1

0

573

Area Involved*

4

4

4

4

4

3

0

574

Opacity

Dull

Dull

1

1

1

1.00

1

0

574

Area Involved*

3

2

2

2

0

Iris

569

Iris

1

1

1

1

1

1.00

1

0

570

Iris

1

1

1

1

1

1.00

0

0

571

Iris

0

0

0

0

0

0.00

0

0

572

Iris

1

1

1

0

0

0.33

0

0

573

Iris

1

1

1

1

0

0.67

0

0

574

Iris

1

1

1

1

0

0.67

0

0

Conjunctivae

569

Redness

2

2

2

2

2

2.00

2

0

569

Chemosis

1

1

1

0

0

0.33

0

0

570

Redness

2

2

2

2

2

2.00

1

0

570

Chemosis

1

1

1

0

0

0.33

0

0

571

Redness

0

1

0

0

0

0.00

0

0

571

Chemosis

0

0

0

0

0

0.00

0

0

572

Redness

2

2

2

1

1

1.33

0

0

572

Chemosis

2

2

1

0

0

0.33

0

0

573

Redness

2

2

2

1

1

1.33

1

0

573

Chemosis

1

1

1

0

0

0.33

0

0

574

Redness

1

2

2

1

1

1.33

1

0

574

Chemosis

1

1

1

0

0

0.33

0

0

*Area of corneal opacity is noted and the observations were taken from the densest area.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
According to the current UN criteria (http://www.unece.org/fileadmin/DAM/trans/doc/2011/dgac10c4/ST-SG-AC10-C4-2011-2e.pdf) adopted in June 2011 (http://www.unece.org/fileadmin/DAM/trans/doc/2011/dgac10c4/ST-SG-AC10-C4-42e.pdf) should be applied (see Example 2) while interpreting classification based on pre-OECD 405 test methods. Following these guidelines classification as eye irritation category 2 applies based on corneal observations.

Executive summary:

In this study, rabbits were administered isooctanol at a dose of 0.1 ml neat solution in the eye. Observations were made at 1, 4, 24, 48, and 72 h and 4 and 7 days post instillation. Eyes were scored for irritation in accordance with the Draize Eye Test. Signs of mild irritation were observed within 1 h post instillation, but resolved to unremarkable by Day 7. There were no signs of corneal damage in any of the test animals.  Individual and mean eye irritation scores are reported in the table. Four out of 6 animals had a mean cornea score of 1. These findings warrant the classification of isooctanol as an eye irritant Category 2 under EU GHS guidelines.