Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 Jun - 05 Jul 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted July 17, 1992

Deviations:

yes

Remarks:

the duration of treatment is 24 hours

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive 92/96 EEC, July 31,1992

Deviations:

yes

Remarks:

the duration of treatment is 24 hours

GLP compliance:

yes

Remarks:

Swiss Federal Office of Metrology, Switzerland

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol

EC Number:

817-761-7

Cas Number:

765293-81-0

Molecular formula:

Not applicable

IUPAC Name:

Fatty acids, C18-unsatd., dimers, hydrogenated, reaction products with Phytosterol, Isooctadecan-1-ol, Hexadecan-1-ol, Octadecan-1-ol and Docosan-1-ol

Test material form:

other: paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne, France
- Age at treatment: male: 10 weeks, females: 11-12 weeks
- Weight at study initiation: male: 2080 g; females: 2149-2169 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet (batch no. 39/02) provided by Provimi Kliba AG (Kaiseraugst, Switzerland), ad libitum
- Water: community tap water from Füllinsdorf, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 23
- Humidity (%): 30- 70
- Air changes (per hr): approx. 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

- Amount applied: 0.5 g

Duration of treatment / exposure:

24 h

Observation period:

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

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: flank area
- Type of wrap if used: A semi-occlusive dressing was wrapped around the abdomen and anchored with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the dressing, the skin was flushed with lukewarm tap water to clean the application site.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2 and #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Irritant / corrosive response data:

Very slight erythema was noted at the test site of two animals 1 h after removal of the dressing and continued to be observed in one animal up to the 24 h reading time point. No abnormal findings were observed at the test site of any animal 48 h after treatment.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Any other information on results incl. tables

Table 1: Skin irritation scores - individual values

Animal Number		Sex		Evaluation Interval		Erythema		Oedema
82 83 84		M F F		1 hour		1 1 0		0 0 0
82 83 84		M F F		24 hours		1 0 0		0 0 0
82 83 84		M F F		48 hours		0 0 0		0 0 0
82 83 84		M F F		72 hours		0 0 0		0 0 0
82 83 84		M F F		Mean (24, 48 and 72 hours)		0.33 0 0		0 0 0

The body weights of all rabbits were considered to be within the normal range of variability.

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:

The test substance was not irritating to the skin of rabbits after an exposure period of 24 h.