(3S)-3,7-Dimethyl-1-octanol

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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

Justification for type of information:

See read-across justification attached in section 13.2

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline followed

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. 50 µl of the test substance was applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours.

GLP compliance:

no

Remarks:

Study carried out prior to GLP principles

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 2.74 kg; female: 2.16 kg
- Diet: Ssniff ad libitum
- water: ad libitum

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount applied 0.05 ml
- Concentration: 100%

Duration of treatment / exposure:

not specified (single application, substance was not washed out)

Observation period (in vivo):

8 days; observations at 10 min, 1 h, 3 h, 24 h, 48 h, 5 d, 7 d, 8 d

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The original grading was converted into the numerical grading according to the OECD Draize system

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

1.5

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Reversibility:

not fully reversible within: 8 days

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48 h

Score:

0.75

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Reversibility:

not fully reversible within: 5 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Reversibility:

not fully reversible within: 5 days

Irritation parameter:

cornea opacity score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Irritation parameter:

conjunctivae score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Irritation parameter:

chemosis score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Remarks on result:

other: not observed

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Remarks on result:

other: not observed

Irritation parameter:

iris score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Irritant / corrosive response data:

See table 1.

Other effects:

Residual test substance or smeary layer on the eye.
In 1 animal small retraction of the eye lid (irregular margin) was observed at the end of the observation period, which was described as Na (= Narbe/Scar) in the original German report.
This finding is not the sequel of irreversible tissue destruction as suggested by the misleading historical wording and does not impair the ocular function.
Thus, it is not relevant for evaluation.

Table1:

Scores for iris, cornea and conjunctiva:

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
1h	1	-		-	1	0		smeary charge
	2	-		-	1	1		smeary charge
24 h	1	1		-	1	1		smeary charge
	2	1		-	2	1		smeary charge
48 h	1	1		-	1	-
	2	1		-	2	1
d 5	1	1		-	1	-
	2	1		-	1	-
d 7	1	-		-	1	-
	2	-		-	1	-
d 8	1	-		-	1	-
	2	-		-	1	-		scars
Mean 24, 48 h	1	1		-	1	0.5
	2	1		-	2	1
Mean 24, 48 h	animals 1 -2	1		-	1.5	0.75

Observations after 8 days with fluorescein: no findings

- = not observed

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

According to the study, the test item was found to be irritating to the eyes and is classified as Category 2.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. 50 µl of the test substance was applied to the conjunctival sac of one eye in 2 animals. The saline-treated adjacent eye served as control. The animals were observed several times on the day of treatment and up to 8 days afterwards. The eyes were not washed out after 24 hours.

GLP compliance:

no

Remarks:

Study carried out prior to GLP principles

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethyloctan-1-ol

EC Number:

203-374-5

EC Name:

3,7-dimethyloctan-1-ol

Cas Number:

106-21-8

Molecular formula:

C10H22O

IUPAC Name:

3,7-dimethyloctan-1-ol

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 2.74 kg; female: 2.16 kg
- Diet: Ssniff ad libitum
- water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount applied 0.05 ml
- Concentration: 100%

Duration of treatment / exposure:

not specified (single application, substance was not washed out)

Observation period (in vivo):

8 days; observations at 10 min, 1 h, 3 h, 24 h, 48 h, 5 d, 7 d, 8 d

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The original grading was converted into the numerical grading according to the OECD Draize system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48 h

Score:

1.5

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

1

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48 h

Score:

2

Reversibility:

not fully reversible within: 8 days

Results 7

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48 h

Score:

0.75

Max. score:

4

Reversibility:

not fully reversible within: 5 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Reversibility:

not fully reversible within: 5 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48 h

Score:

1

Reversibility:

not fully reversible within: 5 days

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Results 13

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48 h

Remarks on result:

other: not observed

Results 14

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48 h

Remarks on result:

other: not observed

Results 15

Irritation parameter:

iris score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

other: observations not made at 72 h

Irritant / corrosive response data:

See table 1.

Other effects:

Residual test substance or smeary layer on the eye.
In 1 animal small retraction of the eye lid (irregular margin) was observed at the end of the observation period, which was described as Na (= Narbe/Scar) in the original German report.
This finding is not the sequel of irreversible tissue destruction as suggested by the misleading historical wording and does not impair the ocular function.
Thus, it is not relevant for evaluation.

Any other information on results incl. tables

Table1:

Scores for iris, cornea and conjunctiva:

Readings	Animal	Cornea		Iris	Conjunctiva			Additional findings
		op	ar		red	ch	di
1h	1	-		-	1	0		smeary charge
	2	-		-	1	1		smeary charge
24 h	1	1		-	1	1		smeary charge
	2	1		-	2	1		smeary charge
48 h	1	1		-	1	-
	2	1		-	2	1
d 5	1	1		-	1	-
	2	1		-	1	-
d 7	1	-		-	1	-
	2	-		-	1	-
d 8	1	-		-	1	-
	2	-		-	1	-		scars
Mean 24, 48 h	1	1		-	1	0.5
	2	1		-	2	1
Mean 24, 48 h	animals 1 -2	1		-	1.5	0.75

Observations after 8 days with fluorescein: no findings

- = not observed

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

According to the study, the test item was found to be irritating to the eyes and is classified as Category 2.