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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:
2015-09-23 to 2015-10-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2015-05-14

Test material

Constituent 1
Reference substance name:
Strontium neodecanoate
Cas Number:
106705-37-7
Molecular formula:
C10H19O2.xSr
IUPAC Name:
Strontium neodecanoate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): strontium neodecanoate
- Molecular weight: 429.6 g/mol
- Physical state: cream/pale yellow solid
- Storage condition of test material: in a tightly closed container, in a dry, cool and well-ventilated place
- Water solubility: 45.07 g/L

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Manfred Bauer Kaninchen, Lohe 7/1, 74632 Neuenstein, Germany
- Age at dosing: approx. 3 - 4 months
- Weight at dosing: 3.0 to 3.2 kg
- Housing: individually housed in cages measuring 380 mm x 425 mm x 600 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, 16352 Schönwalde, Germany); during the exposure the animals were kept in comfortable restrainers.
- Diet (ad libitum before and after the exposure period): commercial diet, ssniff® K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum): tap water
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C (maximum range)
- Relative humidity: 30% - 70% (maximum range)
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/patch
The test item was mortared and moistened with the vehicle.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 mL water
Duration of treatment / exposure:
4 hours
Observation period:
directly after removal of the patch, 60 minutes, 24, 48 and 72 hours after patch removal
Number of animals:
3 female rabbits
Details on study design:
TEST SITE
- Area of exposure/Type of wrap if used: approximately 24 hours before the test, the fur was removed by closely clipping the dorsal area of the trunk of the animals.
The test item was applied to the test site (area: approx. 6 cm²) and then covered with a gauze patch. The patch was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period. The surrounding untreated skin served as a control.

INITIAL TEST AND CONFIRMATORY TEST
- Initial test using one animal:
Three test patches were applied sequentially to the animal. The first patch was removed after three minutes. As no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour. No skin reactions were observed, neither. So a third patch was applied and removed after 4 hours.
- Confirmatory test:
As no skin reactions were observed, the test was completed using two additional animals, each with one patch only, for an exposure period of 4 hours.
SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the three rabbits exposed for 4 hours to 500 mg strontium neodecanoate/patch (semi-occlusive conditions) revealed any skin reaction.
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Strontium neodecanoate is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC, strontium neodecanoate is not classified as irritating to the skin.
According to the EC-Regulation 1272/2008, strontium neodecanoate is not classified as irritating to the skin.

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