Heptadecanol, branched and linear

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:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Test material

Test material information

Constituent 1

Reference substance name:

Heptadecanol, branched and linear

EC Number:

291-378-8

EC Name:

Heptadecanol, branched and linear

Cas Number:

90388-00-4

Molecular formula:

C17H36O

IUPAC Name:

2-methylhexadecan-1-ol; heptadecan-1-ol

Details on test material:

Name of the test substance used in the study report: Heptadecanol N
Purity / Formulation: 99.8%

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Three animals of both sexes were used (age of the male animal: 13 weeks, age of the female animals: 11 weeks).
The rabbits were identified by unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used.
The rabbits were housed in air-conditioned rooms with a room temperature ranging between 17 - 23°C and a relative humidity between 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
Accomodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bottles. Wood blocks and haysticks were provided for gnawing.
A standardized rabbit laboratory diet as well as tap water were available ad libitum.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.1 mL of the test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed.
As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.
Viability/Mortality and clinical signs: Daily from acclimatization of the animals to the termination of the study.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after administration.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

0.22

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: Mean: 0.33 in 2/3 animals, 0 in 1/3 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48//72 hours

Score:

0

Irritant / corrosive response data:

No abnormal findings were obsewed in the cornea or iris of any animal at any of the measurement intervals.
Slight reddening of the conjunctivae was noted in the treated eyes of the three animals 1 hour after the test item instillation and persisted still in two animals at the 24-hour reading.
Two of the animals expressed a slight swelling (chemosis) of the conjunctivae one hour after the treatment.
In addition, sclerae of two animals were found slightly reddened at the 1-hour evaluation.
No abnormal findings were obse~edin the treated eye of any animal 48 hours after treatment.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS