Alcohols, C7-9-iso-, C8-rich

Eye irritation

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Reference 2

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Alcohols, C7-9-branched, C8-rich

EC Number:

295-250-2

EC Name:

Alcohols, C7-9-branched, C8-rich

Cas Number:

91994-92-2

IUPAC Name:

Alcohols, C7-9-branched, C8-rich

Constituent 2

Reference substance name:

Alcohols, C7-9-iso-, C8-rich

EC Number:

271-231-4

EC Name:

Alcohols, C7-9-iso-, C8-rich

Cas Number:

68526-83-0

Molecular formula:

CnH2n+1OH (n = 7 to 9)

IUPAC Name:

Branched alcohols, C7-9, C8 rich

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 569

Time point:

24 h

Score:

1

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: 569

Time point:

48 h

Score:

1

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: 569

Time point:

72 h

Score:

1

Results 4

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

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal: 570

Time point:

24 h

Score:

0

Remarks on result:

other: Dull

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal: 570

Time point:

48 h

Score:

1

Results 7

Irritation parameter:

cornea opacity score

Basis:

animal: 570

Time point:

72 h

Score:

1

Results 8

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

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal: 571

Time point:

24 h

Score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal: 571

Time point:

48 h

Score:

0

Results 11

Irritation parameter:

cornea opacity score

Basis:

animal: 571

Time point:

72 h

Score:

0

Results 12

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

Results 13

Irritation parameter:

cornea opacity score

Basis:

animal: 572

Time point:

24 h

Score:

1

Results 14

Irritation parameter:

cornea opacity score

Basis:

animal: 572

Time point:

48 h

Score:

1

Results 15

Irritation parameter:

cornea opacity score

Basis:

animal: 572

Time point:

72 h

Score:

1

Results 16

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

Results 17

Irritation parameter:

cornea opacity score

Basis:

animal: 573

Time point:

24 h

Score:

1

Results 18

Irritation parameter:

cornea opacity score

Basis:

animal: 573

Time point:

48 h

Score:

1

Results 19

Irritation parameter:

cornea opacity score

Basis:

animal: 573

Time point:

72 h

Score:

1

Results 20

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

Results 21

Irritation parameter:

cornea opacity score

Basis:

animal: 574

Time point:

24 h

Score:

1

Results 22

Irritation parameter:

cornea opacity score

Basis:

animal: 574

Time point:

48 h

Score:

1

Results 23

Irritation parameter:

cornea opacity score

Basis:

animal: 574

Time point:

72 h

Score:

1

Results 24

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

Results 25

Irritation parameter:

iris score

Basis:

animal: 569

Time point:

24 h

Score:

1

Results 26

Irritation parameter:

iris score

Basis:

animal: 569

Time point:

48 h

Score:

1

Results 27

Irritation parameter:

iris score

Basis:

animal: 569

Time point:

72 h

Score:

1

Results 28

Irritation parameter:

iris score

Basis:

animal: 569

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days

Results 29

Irritation parameter:

iris score

Basis:

animal: 570

Time point:

24 h

Score:

1

Results 30

Irritation parameter:

iris score

Basis:

animal: 570

Time point:

48 h

Score:

1

Results 31

Irritation parameter:

iris score

Basis:

animal: 570

Time point:

72 h

Score:

1

Results 32

Irritation parameter:

iris score

Basis:

animal: 570

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 33

Irritation parameter:

iris score

Basis:

animal: 571

Time point:

24 h

Score:

0

Results 34

Irritation parameter:

iris score

Basis:

animal: 571

Time point:

48 h

Score:

0

Results 35

Irritation parameter:

iris score

Basis:

animal: 571

Time point:

72 h

Score:

0

Results 36

Irritation parameter:

iris score

Basis:

animal: 571

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Results 37

Irritation parameter:

iris score

Basis:

animal: 572

Time point:

24 h

Score:

1

Results 38

Irritation parameter:

iris score

Basis:

animal: 572

Time point:

48 h

Score:

0

Results 39

Irritation parameter:

iris score

Basis:

animal: 572

Time point:

72 h

Score:

0

Results 40

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

Results 41

Irritation parameter:

iris score

Basis:

animal: 573

Time point:

24 h

Score:

1

Results 42

Irritation parameter:

iris score

Basis:

animal: 573

Time point:

48 h

Score:

1

Results 43

Irritation parameter:

iris score

Basis:

animal: 573

Time point:

72 h

Score:

0

Results 44

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

Results 45

Irritation parameter:

iris score

Basis:

animal: 574

Time point:

24 h

Score:

1

Results 46

Irritation parameter:

iris score

Basis:

animal: 574

Time point:

48 h

Score:

1

Results 47

Irritation parameter:

iris score

Basis:

animal: 574

Time point:

72 h

Score:

0

Results 48

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

Results 49

Irritation parameter:

conjunctivae score

Basis:

animal: 569

Time point:

24 h

Score:

2

Results 50

Irritation parameter:

conjunctivae score

Basis:

animal: 569

Time point:

48 h

Score:

2

Results 51

Irritation parameter:

conjunctivae score

Basis:

animal: 569

Time point:

72 h

Score:

2

Results 52

Irritation parameter:

conjunctivae score

Basis:

animal: 569

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 53

Irritation parameter:

chemosis score

Basis:

animal: 569

Time point:

24 h

Score:

1

Results 54

Irritation parameter:

chemosis score

Basis:

animal: 569

Time point:

48 h

Score:

0

Results 55

Irritation parameter:

chemosis score

Basis:

animal: 569

Time point:

72 h

Score:

0

Results 56

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

Results 57

Irritation parameter:

conjunctivae score

Basis:

animal: 570

Time point:

24 h

Score:

2

Results 58

Irritation parameter:

conjunctivae score

Basis:

animal: 570

Time point:

48 h

Score:

2

Results 59

Irritation parameter:

conjunctivae score

Basis:

animal: 570

Time point:

72 h

Score:

2

Results 60

Irritation parameter:

conjunctivae score

Basis:

animal: 570

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 61

Irritation parameter:

chemosis score

Basis:

animal: 570

Time point:

24 h

Score:

1

Results 62

Irritation parameter:

chemosis score

Basis:

animal: 570

Time point:

48 h

Score:

0

Results 63

Irritation parameter:

chemosis score

Basis:

animal: 570

Time point:

72 h

Score:

0

Results 64

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

Results 65

Irritation parameter:

conjunctivae score

Basis:

animal: 571

Time point:

24 h

Score:

0

Results 66

Irritation parameter:

conjunctivae score

Basis:

animal: 571

Time point:

48 h

Score:

0

Results 67

Irritation parameter:

conjunctivae score

Basis:

animal: 571

Time point:

72 h

Score:

0

Results 68

Irritation parameter:

conjunctivae score

Basis:

animal: 571

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Results 69

Irritation parameter:

chemosis score

Basis:

animal: 571

Time point:

24 h

Score:

0

Results 70

Irritation parameter:

chemosis score

Basis:

animal: 571

Time point:

48 h

Score:

0

Results 71

Irritation parameter:

chemosis score

Basis:

animal: 571

Time point:

72 h

Score:

0

Results 72

Irritation parameter:

chemosis score

Basis:

animal: 571

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 7 days

Results 73

Irritation parameter:

conjunctivae score

Basis:

animal: 572

Time point:

24 h

Score:

2

Results 74

Irritation parameter:

conjunctivae score

Basis:

animal: 572

Time point:

48 h

Score:

1

Results 75

Irritation parameter:

conjunctivae score

Basis:

animal: 572

Time point:

72 h

Score:

1

Results 76

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

Results 77

Irritation parameter:

chemosis score

Basis:

animal: 572

Time point:

24 h

Score:

1

Results 78

Irritation parameter:

chemosis score

Basis:

animal: 572

Time point:

48 h

Score:

0

Results 79

Irritation parameter:

chemosis score

Basis:

animal: 572

Time point:

72 h

Score:

0

Results 80

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

Results 81

Irritation parameter:

conjunctivae score

Basis:

animal: 573

Time point:

24 h

Score:

2

Results 82

Irritation parameter:

conjunctivae score

Basis:

animal: 573

Time point:

48 h

Score:

1

Results 83

Irritation parameter:

conjunctivae score

Basis:

animal: 573

Time point:

72 h

Score:

1

Results 84

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

Results 85

Irritation parameter:

chemosis score

Basis:

animal: 573

Time point:

24 h

Score:

1

Results 86

Irritation parameter:

chemosis score

Basis:

animal: 573

Time point:

48 h

Score:

0

Results 87

Irritation parameter:

chemosis score

Basis:

animal: 573

Time point:

72 h

Score:

0

Results 88

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

Results 89

Irritation parameter:

conjunctivae score

Basis:

animal: 574

Time point:

24 h

Score:

2

Results 90

Irritation parameter:

conjunctivae score

Basis:

animal: 574

Time point:

48 h

Score:

1

Results 91

Irritation parameter:

conjunctivae score

Basis:

animal: 574

Time point:

72 h

Score:

1

Results 92

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

Results 93

Irritation parameter:

chemosis score

Basis:

animal: 574

Time point:

24 h

Score:

1

Results 94

Irritation parameter:

chemosis score

Basis:

animal: 574

Time point:

48 h

Score:

0

Results 95

Irritation parameter:

chemosis score

Basis:

animal: 574

Time point:

72 h

Score:

0

Results 96

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.