Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Basazol Gelb 8511
- Physical state: powder
- Analytical purity: 96 %
- Lot/batch No.: 6123 V. 6781

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Savo; Med Versuchstierzuchten GmbH; Kisslegg
- Weight at study initiation: 2.2 (female) - 2.41(male) kg
- Housing:cage made of stainless steel with wire mesh walk floor; floor area 40 cm X 51 cm
- water:250 ml/d tap water
- Acclimation period: at least 8 days before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): central air conditioning guaranteed a range of 20 -24 degrees celsius
- Humidity (%): 30 - 70 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00 - 18.00 hours/ 18.00 - 6.00 hours)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.5 ml


Duration of treatment / exposure:
Exposure period: 4 h
Observation period:
72 h
Number of animals:
2 male; 1 female
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of th exposure period with Lutrol and Lutrol/water (1:1)
SCORING SYSTEM:
OECD Draize Score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4- 24- 48 - 72 h
Score:
0.1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 - 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:
Classification: not irritating