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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 August - 21 September 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD 404) and in compliance with GLP.

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
IN 78281
IUPAC Name:
IN 78281
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): IN00078281 (IN 78281)
- Physical state: White powder
- Analytical purity: The Certificate of Analysis was provided to the Study Director
- Lot/batch No.: 7889-058-10
- Expiration date of the lot/batch: Dec 2006
- Stability under test conditions: Stability data on bulk test material was not provided to the Study Director
- Storage condition of test material: Room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan, Oxford, MI
- Age at study initiation: 19 weeks at start of dosing
- Weight at study initiation: 2.9-3.1 kilograms at the outset (day 1) of the study
- Housing: individually according to USDA guidelines
- Diet (e.g. ad libitum): ad libitum, PMI Certified Hi-Fiber Rabbit Diet #5325
- Water (e.g. ad libitum): ad libitum, tab water
- Acclimation period: study animals were acclimated to their housing for a minimum of five days prior to dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 to 21°C
- Humidity (%): 32 to 72 %
- Air changes (per hr): The room in which the animals were kept was documented in the study records
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
physiological saline
Controls:
not specified
Amount / concentration applied:
500 mg of the test material with 0.5 ml saline
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after exposure
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal drunk
- % coverage: 5 cm * 5 cm
- Type of wrap if used: non-irritating wrap

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the test item, was found to be a non-irritant to the skin of rabbits with a Primary Irritation Index score of 0.