cyclohexadecanone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Feb - 03 Mar 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(Commission Directive 92/69/EEC)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

438-930-8

EC Name:

-

Cas Number:

2550-52-9

Molecular formula:

C16H30O

IUPAC Name:

cyclohexadecanone

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF Crl:NZW

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2955 - 3292 g
- Housing: in stainless steel cages (50 x 55 x 40 cm) with bottom grid of oval steel and with tub for faeces, granulated soft wood bedding
- Diet: ALTROMIN 2123 standard diet for rabbits (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 22.5
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g
The test substance was crushed with a pestle and mortar to a fine dust before application.

Duration of treatment / exposure:

24 hours
single application without washing

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

4 males

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3, #4

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #2, #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

A slight redness of the conjunctivae (score 1) of the treated eyes was observed in all four animals on the day of instillation and in three animals until 24 hours after exposure. A slight swelling of the conjunctivae (score 1) was observed in all four animals on the day of exposure and in two animals until 24 hours after exposure. The cornea and iris were not affected. 48 hours after exposure no signs of irritation were observed. The control eyes of the animals showed no alterations at any observation time.

Any other information on results incl. tables

Table 1. Results of the eye irritation study

Alteration	Animal No.	Time (h)
		1	24	48	72	mean 24/48/72	Overall mean (24/48/72)/ 4 animals
Cornea	1	0	0	0	0	0	0
	2	0	0	0	0	0
	3	0	0	0	0	0
	4	0	0	0	0	0
Iris	1	0	0	0	0	0	0
	2	0	0	0	0	0
	3	0	0	0	0	0
	4	0	0	0	0	0
Conjunctivae Redness	1	1	1	0	0	0.33	0.25
	2	1	0	0	0	0
	3	1	1	0	0	0.33
	4	1	1	0	0	0.33
Conjunctivae Chemosis	1	1	1	0	0	0.33	0.17
	2	1	0	0	0	0
	3	1	1	0	0	0.33
	4	1	0	0	0	0

No animal died during and no clinical signs were observed during the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.

Executive summary:

The eye irritation potential of the test substance was investigated in four albino rabbits according to OECD Guideline 405 (1987) and in compliance with GLP. 0.1 g of the test substance, which was crushed to a fine dust, was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 1, 24, 48 and 72 hours after application. A slight redness of the conjunctivae (score 1) of the treated eyes was observed in all four animals on the day of instillation and in three animals until 24 hours alter instillation. A slight swelling of the conjunctivae (score 1) was observed in all four animals on the day of instillation and in two animals until 24 hours after instillation.The cornea and iris were not affected. The mean scores at 24/48/72 of all 4 animals for redness, chemosis, cornea and iris was 0.25, 0.17, 0 and 0, respectively. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.