(Z)-N-octadecyldocos-13-enamide

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:

guideline study

Remarks:

GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-octadecylstearamide

EC Number:

236-276-6

EC Name:

N-octadecylstearamide

Cas Number:

13276-08-9

Molecular formula:

C36H73NO

IUPAC Name:

N-octadecyloctadecanamide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 2.45-2.56 kg
- Housing: Individually in metal cages with perforated floors.
- Diet: Standard laboratory animal diet (LK-01, pellet diameter 4 mm; 100 g per day), obtained from Hope Farms, Woerden.
- Water: Tap-water, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 60-80
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eyes served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 90±1 mg (equivalent to 0.1 mL)

Test substance preparation: Test substance was ground to a fine powder using a mortar and pestle. On the day of dose administration three portions of 90±1 mg of the powder were dispensed in glass containers with screw caps.

Test substance administration: On administration one of the portions of the test substance was instilled into the conjunctival sac of the left eye of each animal using a spatula. The lids were then held gently together for two seconds and released. The other eye remained untreated and served as control. Immediately after instillation the animals were observed and abnormalities were recorded.

Duration of treatment / exposure:

Not washed out

Observation period (in vivo):

100 minutes, 24, 48 and 72 hours, 4 and 7 days

Number of animals or in vitro replicates:

3 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Solution of 2% fluorescein approximately 24 hours after instillation, immediately after scoring of corneal opacity and alterations of iris and conjunctivae. The procedure was repeated for one of the animals 3 days after dose administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: Fluorescence: 5% of corneal area affected on day 1, fully reversible by day 3

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

At the first observation time hyperaemia of blood vessels of the conjunctivae, affecting the eyelids and the scleral conjunctivae, was observed in all animals; the eyelids were also slightly to moderately swollen. Increased lacrimation was observed in 2/3 animals. The swelling disappeared in all animals within the next 24 to 48 hours, whereas slight redness persisted for 2 to 4 days. On day 7 the conjunctival effects had disappeared in all animals.

Treatment of the eyes with fluorescein 24 hours after instillation of the test substance revealed 5% corneal epithelial damage in 1/3 animals, but no damage in the other two animals; when this procedure was repeated for the concerned animal on day 3 no epithelial damage was observed. Apart from this effect no adverse effects on the cornea and the iris were observed in any of the rabbits during the entire observation period.

Other effects:

Signs of systemic intoxication were not observed.

Any other information on results incl. tables

Conclusion:

According to the criteria of Regulation (EC) No 1272/2008 the test substance does not have to be classified as irritating to the eyes.

Applicant's summary and conclusion

Interpretation of results:

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