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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:
21 - 24 Jul 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in 2002
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2015
Deviations:
yes
Remarks:
reported humidity ranged between 25 - 75% instead of 30 - 70% as recommended by the guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive No. 440/2008
Version / remarks:
adopted in 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
adopted in 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Arbeit, Gesundheit und Soziales, Düsseldorf, Germany

Test material

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: young adult animals
- Weight at study initiation: 3.2 - 3.3 kg
- Housing: Individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding (Rettenmaier & Söhne GmbH & Co, Rosenberg, Germany).
- Diet: Ssniff K-Z 4mm (Ssniff Spezialdiäten GmbH, Soest, Germany), approximately 100 g per animal per day
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 25
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g of the pulverised test substance moistened with water was applied to the skin.
Duration of treatment / exposure:
4 h
Observation period:
14 days
Reading time points: after 1, 24, 48 and 72 hours and after 7 and 14 days
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm2 on the dorso-lateral side of the trunk
- Type of wrap if used: The patch was held in place with non-irritant tape.

REMOVAL OF TEST SUBSTANCE
- Washing: The exposed skin area was carefully washed with water without altering existing response, or the integrity of the epidermis.
- Time after start of exposure: 4 h

SCORING SYSTEM:
- Method of assessment of skin reaction: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Irritant / corrosive response data:
No skin reaction was noticed.
Other effects:
No clinical signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was tested for skin irritation in rabbits according to OECD guideline 404. No skin reaction was noticed and the test item was considered not to be a skin irritant.