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Diss Factsheets

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:
17 September 2009 - 12 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
zinc(2+) 3-hydroxypropane-1,2-bis(olate)
EC Number:
700-107-9
Cas Number:
87189-25-1
Molecular formula:
(C3H6O3Zn)n
IUPAC Name:
zinc(2+) 3-hydroxypropane-1,2-bis(olate)
Details on test material:
- Substance type: Organic
- Physical state: Powder
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain as stated in the report: New Zealand white Crl:KBL (NZW) SPF
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, 88353 Kisslegg
- Age at study initiation: ca. 9 months
- Weight at study initiation: 2300 - 2700 g
- Housing: individually in terulan cages
- Diet ad libitum: Ssniff K-H maintenance diet for rabbits
- Water ad libitum: tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: untreated skin area served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g (minimally moistened with highly deionised water)
Duration of treatment / exposure:
4 h
Observation period:
0, 1, 24, 48 and 72 h after removal of the patch.
Number of animals:
3 animals
Details on study design:
0.5 g of moistened test article was applied to intact skin on a patch of 2.5 cm x 2.5 cm and covered with semiocclusive dressing. After removal of the patch the application area was washed off with Lutrol and Lutrol/water (1:1). Since no effects were observed within 72 h the study was discontinued therafter.
The evaluation of skin reactions was performed according to the quoted guidelines.


EVALUATION
For evaluation, the calculation of the mean values of erythema and edema for readings at 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account.
The evaluation is based on the criteria of the OECD Harmonized Integrated Classification System that was in place on the date of report signature (November 2009)

SCORING SYSTEM
Erythema and eschar formation
Grading
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to eschar formation preventing grading of erythema

Edema formation
Grading
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges of area well defined by definite raising)
3 Moderate edema (raised approx. 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)

Descriptions of any dermal findings not covered by this scale were recorded.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24; 48; 72 h
Score:
0
Max. score:
4
Reversibility:
other: since no erythema was observed, not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: since no edema was observed, not applicable
Other effects:
No cutaneous reactions were observed in all animals during the study. No clinical signs of intoxication were reported in the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met