2-hydroxy-N-((2S,3S,4R)-1,3,4-trihydroxyoctadecan-2-yl)octadecanamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-01-28 to 1992-01-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

September 1984

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-

Cas Number:

34354-88-6

Molecular formula:

C36H73NO4

IUPAC Name:

Octadecanamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-

Test material form:

solid: particulate/powder

Details on test material:

Ceramide III

Specific details on test material used for the study:

The test substance was determined not to be miscible with water and static.
The test substance was ground to a powder using a mortar and pestle.
To ensure close contact to the animal’s skin, the powdery test substance was applied using a patch, which was moistened with distilled water immediately before use.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

- Rabbit, New Zealand White, (SPF-Quality)
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 13 weeks
- Weight at study initiation: 2311-2833 grams
- Housing: conventionally, singly in stainless steel cages with perforated floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands)
- diet: ad libitum, standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day.
- Water: ad libitum, tap-water diluted with decalcified water
- Acclimation period: at least 5 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- no vehicle; test substance was applied using a moistened patch
NEGATIVE CONTROL
- The contralateral flank was similarly prepared, but without test substance
.

Duration of treatment / exposure:

4 hours

Observation period:

50 min, 24 h, 48 h and 72 h after removal of the dressings and test substance

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- % coverage: 100 %. Due to the physical properties of the test substance the amount of 0.5 g could not be dosed completely within the area that was covered by the patch (6 cm²) and a small amount was applied outside this area.
- Type of wrap if used: moistened Scotchpak-non-woven patch (2x3 cm, 3M, St. Paul, U.S.) mounted on Micropore tape (3M, St. Paul, U.S.). The dressing was wrapped around the abdomen and secured with an elastic bandage (Coban, 3M, St. Paul, U.S.)
REMOVAL OF TEST SUBSTANCE
- the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours
SCORING SYSTEM: the test results were evaluated according to OECD guideline No. 404, “Acute Dermal Irritation/Corrosion”, adopted 28 July 2015.
 

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: #1,#2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: 50 min

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: 50 min

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Other effects:

No other effects reported.

Any other information on results incl. tables

IRRITATION

No skin irritation was caused by the test substance after a 4 h dermal application.

CORROSION

There was no evidence of a corrosive effect on the skin.

COLOURATION

No staining of the treated skin by the test substance was observed.

TOXICITY SYMPTOMS, MORTALITY

No symptoms of systemic toxicity were observed in the animals during the test period. No mortality occurred.

Table: Irritant/corrosive response data at each observation time point (mean of all animals).

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
50 min	0/0/0	0/0/0
24 h	0/0/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this study, the test substance did not cause any irritation and thus, classification is not required.

Executive summary:

In this skin irritation / corrosion study according to OECD Guideline No. 404 (May 12, 1981) and EEC Directive 84/449/EEC, Part B.4 (September 1984), 0.5 g of Ceramide III was applied onto shaved skin of three New Zealand White male albino rabbits using semi-occlusive dressings for 4 hours. An adjacent area of untreated skin, similarly prepared but without test substance and vehicle served as control area.

After 4 hours, Ceramide III was removed using tissue moistened with tap-water. Observations were made after 50 minutes, 24, 48, and 72 h after patch removal.

No reactions were seen; mean erythema and oedema scores after 24, 48, and 72 h were 0 in all animals.

Based on the results of this test, Ceramide III is not irritating to skin.