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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:
14 Apr - 17 May 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The observation period was 72 hours.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was pulverized.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Age at study initiation: approximately 6 months
- Weight at study initiation: 3020 - 3175 g
- Housing: individually in metal cages with excrement tray
- Diet: ,,Ssniff K-2" 4mm (manufacturer: Ssniff Spezialdiaeten GmbH, Soest, Germany), approximately 100 g/animal/day; once per day in the moming
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): approximately 12/12

IN-LIFE DATES: From: 14 Apr 2004 To: 17 Apr 2004

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Remarks:
(approximately 24 h before application)
Vehicle:
water
Controls:
other: the untreated contralateral skin area served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 - 502 mg

Duration of treatment / exposure:
1st animal: 3 min, 1 h, 4 h
2nd and 3rd animal: 4 h
Observation period:
72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: The test material was applied to the dorsolateral area of the trunk (treated skin was approximately 2.5 x 2.5 cm in size).
- Type of wrap if used: The test material was moistened with sterile water and was covered with a gauze patch which was held in place with "Surgifix No. 5" (Schumacher, Medical Produkte, Krefeld, Germany)

REMOVAL OF TEST SUBSTANCE
- Washing: The exposed skin was carefully washed with water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1st animal: immediately after patch removal (3 min and 1 h treatment); 1, 24, 48 and 72 h after patch removal (4 h treatment)
2nd and 3rd animal: 1, 24, 48 and 72 h after patch removal

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals (4 h treatment)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals (4 h treatment)
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation or corrosion were noted after treatment for 3 min or 1 h. No signs of irritation or corrosion were noted immediately after treatment for 4 h.
Other effects:
- Other adverse systemic effects: There were no relevant systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified