4-methyl-3-decen-5-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

3 concentrations were used to determine the minimal irritating and the maximal non-irritating dose. The top dose employed was 100 %

Principles of method if other than guideline:

Adaptation of the Draize (1955) method.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-methyl-3-decen-5-ol

EC Number:

279-815-0

EC Name:

4-methyl-3-decen-5-ol

Cas Number:

81782-77-6

Molecular formula:

C11H22O

IUPAC Name:

4-methyldec-3-en-5-ol

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: no data

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

Diethyl Phthalate or unchanged

Controls:

no

Amount / concentration applied:

TEST MATERIAL:- Amount(s) applied (volume or weight with unit): 0.1mL of the test material applied to one eye (the untreated eye served as the control)- Concentration (if solution): 100, 30 and 10 %.- Dilutions were made in Diethyl Phthalate.

Observation period (in vivo):

The observation period was 14 days at the following time points: 0, 1, 24, 48, 72 hours and day 7 and 14.

Number of animals or in vitro replicates:

3 rabbits per concentration.

Details on study design:

REMOVAL OF TEST SUBSTANCE- Washing: NoSCORING SYSTEM:- Draize scale (1977).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.34

Max. score:

7

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: 100 % concentration

Irritant / corrosive response data:

Scores were calculated as means of three animals as an average of 24, 48 and 72 hours.

Any other information on results incl. tables

Table 2. Irritation Reading From Application of Test Material at 100 %

			1 hour			24 hours			48 hours			72 hous			7 days			14 days
		Animal No.	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3	1	2	3
Observation		Concentration
CORNEA	Opacity	100%	0	0	1	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0
	Area of Opacity		0	0	0	0	0	3	0	0	1	0	0	1	0	0	0	0	0	0
	Ulceration		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Stain retention		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
IRIS			0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
CONJUNCTIVA	Redness		2	2	2	2	2	2	2	2	2	1	1	1	0	0	0	0	0	0
	Chemosis		1	1	1	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0
	Ulceration		0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
DISCHARGE			1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The test material was determined to be unclassified for eye irritation. Application of the undiluted test material caused moderate conjunctival irritation and corneal opacity which only lasted 3 days, however these effects are not severe enough to require classification under Regulation 1272/2008.

Executive summary:

In a non GLP compliant study the eye irritation of the test material was determined according to an adapted Draize method. Three rabbits were exposed to the neat test material and dilutions of 10 and 30 %. The effects were observed over 14 days and scored according to the Draize scale. In the case of the undiluted application, conjunctival redness, slight chemosis and corneal opacity were observed, however these effects only lasted 3 days. The effects seen as a result of exposure to the test material are not severe enough to require classification under Regulation 1272/2008.