Registration Dossier
Registration Dossier
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EC number: 482-400-9 | CAS number: 138776-88-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 March - 18 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study (OECD).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- April 24, 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 30 May, 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- august 1998
- Qualifier:
- according to guideline
- Guideline:
- other: japan MAFF Testing guideline of Nousan No. 8147, Nov 24, 2000
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay, Labor fuer biologische Analytik GmbH, Heidelberg, Germany
Test material
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
- Details on test material:
- - Name of test material (as cited in study report): L4-Ligand
- Physical state: white solid
- Analytical purity: 97.0g/100g ± 0.3g/100g
- Lot/batch No.: 0005473663
- Expiration date of the lot/batch: 01 February, 2013
- Storage condition of test material: room temperature, under N2, protected against humidity
- Other: homogeneous by visual inspection
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: 8 - 9 months
- Weight at study initiation: 4.24 - 4.79 kg
- Housing: single housing in stainless steel wire mesh cages with grating with shallow cage body, enriched with wooden gnawing blocks
- Diet: STANRAB (P) SQC; SDS Special Diets Services, Altrip, Germany
- Water: tap water, ad libitum
- Acclimation period: at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 - 70 %
- Air changes (per hr): approximately 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied: the test item was minimally moistend with suitable amount of deionized water to guarantee skin contact immediately before test item application - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
reading time points: 1, 24, 48 and 72 hours - Number of animals:
- 3, sequential testing
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5
- Type of wrap if used: Fixomull strecht (adhesive fleece)
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water (1:1) - (Polyethylenglycol, BASF)
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal#1 - animal#3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal#1 - animal#3
- Time point:
- other: mean over 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- No cutaneous reactions were observed during the study.
- Other effects:
- No other clinical signs were observed during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- DSD: not classified
CLP: not classified
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