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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:
from 8-FEB-94 to 11-FEB-94
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with OECD guideline standard method and Good Laboratory Practice. No information on purity of batch of test substance but company documentation is available.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
EC Number:
915-316-2
Molecular formula:
C50H80O4
IUPAC Name:
Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Source: Elevage Cunicole de Val de Selle (80160 Prouzel), France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +- 0.3 kg
- Housing: individually in polystyrene cages (35 x 55 x 32 cm) in an environmentally controlled room
- Diet: UAR "112 C" pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France), ad libitum. (composition and contaminants analysis by the supplier.
- Water: filtered drinking water (0.22 µm), ad libitum. Bacteriological and chemical analysis performed periodically.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature: 18 +- 3°C
- Humidity: 30-70 %
- Air changes: no data
- Photoperiod: 12h light-dark cycle

IN-LIFE DATES: from 8-FEB-1994 to 11-FEB-1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: not required since untreated left flank served as negative control
Amount / concentration applied:
TEST MATERIAL
-Amount applied (volume or weight with unit): 0.5 g of test substance as supplied
-Concentration (if solution): /
-pH: 4.6 (analysis at CIT)

Duration of treatment / exposure:
4 hours
Observation period:
Observation at 1, 24, 48 and 72 hours (in the absence of dermal irritation, the study is ended at 72 hours).
Number of animals:
6
Details on study design:
TEST SITE:
- Area of exposure: one square inch (6 cm2)
- % coverage: data not available
- Type of wrap if used: gauze patch was kept in skin contact with an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE:
- Washing: no residual test substance was observed
- Time after start of exposure: 4 hours

SCORING SYSTEM: in accordance with Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Over 24 to 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Very slight erythema (score 1) was observed only on one skin site at the 1-hour reading.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Over 24h to 72h.
Score:
0
Max. score:
4
Reversibility:
other: no edema observed at any time

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

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

 Reversibility  NA  NA

NA: Not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as a skin irritant according to the criteria of annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
Executive summary:

RHODIASTAB X5 has been tested for acute skin irritation on 3 male New Zealand White rabbits, according to O.E.C.D. guideline Nb.404 and Directive 67/548/EEC and in compliance with Good Laboratory Practice. The test substance was applied as supplied, on a compress moistened with water, in a single dermal dose of 0.5 g, to a 6 cm2clipped area of the right flank skin during 4 hours under a semi-occlusive dressing. The untreated left flank served as negative control. The cutaneous examinations were performed 1, 24, 48 and 72 hours after removal of the dressing.

No edema was noted. Erythema score 1 was observed only at one hour in one animal. The mean individual score calculated for 24-48-72 hours was 0.0-0.0-0.0 for erythema and 0.0-0.0-0.0 for edema.

Based on these results, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified as a skin irritant according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).