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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 january 2002 - 05 february 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD TG 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
SOURCE OF TEST MATERIAL
- Purity: 94.0 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark.
Specific details on test material used for the study:
Batch: 62630012
Expiry date: 01 November 2002

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Albino rabbit (SPF-Quality)
Details on test animals and environmental conditions:
Test animals
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: Animals used within the study were at least 6 weeks old
- Weight at study initiation: weights were between 1.0 and 3.5 kg
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, dimensions 53.5x63x38.5 cm). Acclimatisation period was at least 5 days before start of treatment under laboratory conditions.
- Diet: Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits,Altromin, Germany) approx. 100 g per day
- Water: Free access to tap-water

Environmental conditions
- A controlled environment was maintained in the room with optimal conditions considered as being approximately 15 air changes per hour, a temperature of 21±3°C, a relative humidity of 30-70% and 12 hours artificial fluorescent light and 12 hours dark per day.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Ethanol
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Concentration applied: Each animal was treated by dermal application of 0.5 grams of the test substance.
- Vehicle: Since the test substance did not mix with water, the powdery test substance was moistened with watery ethanol (50% v/v), immediately before application, to ensure close contact with the animal's skin.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours and 7 days after exposure
Number of animals:
3
Details on study design:
Treament
- Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm^2). Whenever considered necessary, the treated skin areas were re-clipped at least 3 hours before the observations to facilitate scoring.
- A health inspection was performed prior to the commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the skin to be treated, which was intact and free from abnormalities.
- Each animal was treated by dermal application of 0.5 grams of the test substance. The test substance was moistened with 0.7 ml of the vehicle and applied to the skin of one flank, using a metalline patch of 2x3 cm. The patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage. Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using water.

Obervation
- Mortality/Viability: twice daily
- Toxicity: at least once daily
- Body Weight: Day of treatment (prior to application)
- Irritation: The skin reactions were assessed at approximately 1, 24, 48 and 72 hours and 7 days after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded. Adjacent areas of the untreated skin of each animal served as controls

The irritation was assessed according to a numerical scoring system (according to guideline).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 123
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 124
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 125
Time point:
24/48/72 h
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 123
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 124
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 125
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Irritation
Four hours exposure to 0.5 g of PHYTOSPHINGOSINE resulted in very slight to well-defined erythema and very slight to slight oedema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 7 days after exposure in all animals. Scaliness was noted 7 days after the removal of the dressings and test substance.

Corrosion
There was no evidence of a corrosive effect on the skin.
Other effects:
Colouration
No staining of the treated skin by the test substance was observed.

Toxicity / Mortality
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table1. Individual skin Irritation scores.

Animal# 123 124 125
Time after exposure Erythema Oedema comments Erythema Oedema comments Erythema Oedema comments
1hour 2 1 - 2 2 - 2 2 -
24hour 2 1 - 2 1 - 2 1 -
48hour 2 1 - 2 1 - 2 1

-

72hour 1 0 - 2 1 - 1 1 -
7days 0 0 1 0 0 1 0 0 1

Table2. Mean value Irritaion scores.

Animal# Mean 24-72hrs
Erythema Oedema
123 1.7 0.7
124 2.0 1.0
125 1.7 1.0

Table3. Animal Specifications

Animal# Mean 24-72hrs
Sex Age(weeks) Body weight(grams)
123 male 7-9 1421
124 male 7-9 1651
125 male 7-9 1493

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
acc. to CLP Regulation
Conclusions:
The test item phytosphingosine is slightly irritating to skin. Skin irritation resolved within 7 days after exposure in all animals. There was no evidence of a corrosive effect on the skin.
Executive summary:

Primary skin irritation/corrosion of phytosphingosine was investigated in rabbit (4 -hour semiocclusive application) and carried out according to OECD 404 and in compliance with GLP.

Four hours exposure to 0.5 g of phytosphingosine resulted in very slight to well-defined erythema and very slight to slight oedema in treated skin-areas of three rabbits. Skin irritation had resolved within 7 days after exposure in all animals. Moreover, there was no evidence of a corrosive effect on the skin. In conclusion, phytosphingosine is slighlty irritating to skin.

The study was considered reliable and adequate for hazard assessment of human health.