5-cyclohexadecen-1-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July - 24 July 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

EC Number:

401-700-2

EC Name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

Cas Number:

3100-36-5

Molecular formula:

C16H28O

IUPAC Name:

8-Cyclohexadecen-1-one

Specific details on test material used for the study:

Name (as stated in the report): 8-CYCLOHEXADECENONE
Batch: 0390010860403
Appearence: Colorless crystalline solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Healthy male, young adult, New Zealand White albino rabbits (body weight range 2500-3500 g), obtained from ENKI-Konijnenfarm, Someren, the Netherlands, were used as the experimental animals. The animals were identified by earmarking and subsequently housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front. The cages were placed in a room, controlled for light (12 hours light/12 hours dark cycle), temperature (18 + 3°C), ventilation (c. 10 air changes/hour), and relative humidity (of least 40%) throughout the test period. A standard laboratory rabbit diet and tap water were provided ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

One tenth of a milliliter of the undiluted melted test substance

Duration of treatment / exposure:

instillation

Observation period (in vivo):

Eye effects were examined after one hour, and after 24, 48 and 72 hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: 3830, 3831 and 3832

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: NA

Results 2

Irritation parameter:

iris score

Basis:

animal: 3830, 3831 and 3832

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: NA

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal: 3830, 3831 and 3832

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: NA

Results 4

Irritation parameter:

chemosis score

Basis:

animal: 3830, 3831 and 3832

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: NA

Irritant / corrosive response data:

After one hour, the eye effects observed consisted of slight redness and slight swelling of the conjunctivae in all (three) rabbits.
After 24 hours, all eye effects had cleared completely. After 48 and 72 hours as well, no signs of eye irritation were observed in any of the (three) rabbits.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

On the basis of the results obtained it is concluded that, the undiluted test substance 8-cyclohexadecenone is not an eye irritant and not corrosive to eyes under the conditions of the test. It does not met the criteria for eye irritation classication according the CLP Regulation (EC) No. 1272/2008.

Executive summary:

The 8-CYCLOHEXADECENONE was tested in this study to evaluate the eye irritation potential accoridng to the OECD guideline 405.

Both eyes of each rabbit provisionally selected were examined within 24 hours before testing. Three animals without observable eye effects were used. One tenth of a milliliter of the undiluted melted test substance, cooled down to 30°C, was allowed to fall on the everted lower lid of one eye of each rabbit. After administration the upper and lower eye lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control..

The eyes were not washed out following administration and the animals were released immediately.

Eye effects were examined after one hour, and after 24, 48 and 72 hours. On the basis of the results obtained it is concluded that, the undiluted test substance 8-cyclohexadecenone is not an eye irritant and not corrosive to eyes under the conditions of the test. It does not met the criteria for eye irritation classication according the CLP Regulation (EC) No. 1272/2008.