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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:
1/02/1999-21/02/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid
Details on test material:
name: SEPIFEEL ONE
batch: 98174300
aspect: white solid
Specific details on test material used for the study:
Container: plastic flask
Batch n° 98174300
Form: white wax flakes
Storage: dark, Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals
Three male albino New Zealand rabbits were supplied by the Elevage Charles RIVER (76410 Saint-Aubin-Les-Elbeuf, France).
They were kept during a minimal 5-day acclimatisation period. The day before application of the substance, the weight was superior to 1.8 kg.
Housing
Each animal was kept in an individual box (60 cm x 45 cm x 32 cm) installed in conventional air conditioned.
The environmental conditions were:
- temperature : between 17°C and 23°C
- relative humidity : between 30% and 70%
- lighting time: 12 hours daily
Feeding: the complete diet was supplied under pelleted form ERGILAP Anco delivered by COFNA (37018 TOURS, France)
Drinking: tap water distributed in polypropylene feeding-bottles with stainless steel teat. A sample of water is taken after each technical intervention from the pipes and every 6 months at least and sent for chemicophysical and bacteriological analysis to a specialized control organization.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: The test item was applied on an undamaged skin area of one flank of each animal. On the opposite flank, an untreated area served as control.
Amount / concentration applied:
0.5 g for each animal applied moistened with 0.2 ml of distileed water.
Duration of treatment / exposure:
during 4 hours
Observation period:
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours and unitl 20 days after removal of the patch.
Number of animals:
3 males
Details on study design:
Treatment
Approximately 24 hours before the test, the rabbits’ backs and flanks were shorn, so as to expose an area of skin about 6 cm2.
The test item was applied, as supplied, at 0.5 g, on an undamaged skin area of one flank of each animal, during 4 hours. The patch was secured in position with a strip of surgical adhesive tape.
Grading of reactions
The skin reactions were appreciated 1 hour and then 24, 48 and 72 hours until 20 days after removal of the patch.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2.7
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 3
Max. score:
3
Reversibility:
not fully reversible within: 20 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
ca. 2.3
Max. score:
3
Reversibility:
not fully reversible within: 20 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
ca. 2.7
Max. score:
3
Reversibility:
not fully reversible within: 20 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Taking into account the criteria defined by the EEC 67/548 Directive and its successive amendments, the substance Sepifeel One was classified among the substances corrosive to the skin.
Executive summary:

Test product: Sepifeel One Batch 98174300

Principle of the study: The aim of the study was to assess qualitatively and quantitatively irritancy or corrosion and the delay of appearance after single skin application of 0.5 g of test substance previously moistened with distilled water, under semi-occlusive dressing for 4 hours, in 3 rabbits.

The skin irritation reactions (erythema and oedema) were scored 1, 24, 48, 72 hours and until 20 days after patch removal. The test substance was classified in accordance with the EEC 67/548 Directive and its amendments.

Dates of the study: from 01/02/1999 to 21/02/19999

Results:

 

    Mean score 24h, 48h and 72h after application

 Animals Erythema Oedema 
 7926  3.0  2.3
 7927  2.7  2.0
 7928  3.0

 2.7

Conclusion: The test substance is classified among the substances corrosive to the skin.