Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 28th, 2007 to July 6th, 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP and OECD method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Off white crystalline solid stored at room temperature in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Accredited supplier
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: Animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet
- Water (e.g. ad libitum): Drinking water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): At least 15 changes
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: June 28th, 2007 To: July 6th, 2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: distilled water
Controls:
other: contralateral zone of same animal
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
Site: 1, 2, 2
Duration: 3 min., 1 hr., 4 hrs.
Observation period:
1hr, 24hr, 48hr and 72hr after removal of the patches
Number of animals:
3
Details on study design:
- Duration of observation period following administration: 3 days
- Frequency of observations and weighing: Approximately one hour following the removal of the patches, and 24, 48, and 72 hours later, the test sitewere examined for evidence of primary irritation and scored according to the scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 0)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritant / corrosive response data:
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification
scheme. No corrosive effect were noted.
Other effects:
There were no signs of dermal effects.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was classified as non-irritant to the skin. The test material did not meet the criteria for classification as irritant or corrosive
according to the EU labelling regulations Commission Directive 2001/59/EC.