Heptadecanol, branched and linear

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three animals of both sexes were used (age at treatment: 15 weeks - male, 16 weeks - females).
The rabbits were identified using unique cage number and corresponding ear number.
Acclimatization: Under laboratory conditions after health examination. Only animals with any visual signs of illness were used for the study.
Conditions: Air-conditioned rooms with a room temperature between 17 and 23°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h light and 12 h dark.
The animals were held in stainless steel cages with feed hoppers and drinking water bowls.
A standardized animal laboratory diet as well as tap water were available ad libitum.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: intact skin of the clipped area

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 h

Observation period:

14 days

Number of animals:

3

Details on study design:

Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm2 (10 cm x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was clipped again.
Animals with overt signs of skin injury or marked irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.5 ml of Heptadecanol N was placed on a surgical gauze patch (ca. 2.5 cm x 2.5 cm). This gauze patch was applied to the intact skin of the clipped area. The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
The duration of treatment was 4 hours. Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
As it was suspected that the test item might produce irritancy, a single animaI (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 4-hour exposure, the test was completed using the two remaining animals for an exposure period of four hours.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

2

Reversibility:

not fully reversible within: 14 days in 1/3 animals

Remarks on result:

other: mean score 2 in each of 3/3 animals

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: mean score 1 in each of 3/3 animals

Irritant / corrosive response data:

A well-defined erythema and a slight swelling was noted in all three animals from the 1-hour reading up to the 72-hour evaluation. The erythema persisted as very slight in one animal up to test day 10 and in another animal up to test day 14. Additionally, a scaling of the skin was present from the 48-hour reading until test day 7 in the two animals showing persisting erythema, and from test day 7 until the end of observation in the third animal without other findings.
At the end of the two week observation period, one animal still expressed very slight erythema and one animal scaling.

Other effects:

No staining produced by the test item of the treated skin was observed.

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Remarks:

Migrated information