Registration Dossier
Registration Dossier
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EC number: 600-026-8 | CAS number: 1000817-22-0
Skin irritation / corrosion
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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- EC Number:
- 600-026-8
- Cas Number:
- 1000817-22-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Kerocom FM 38
- Physical state: liquid
- Analytical purity: 100% (UVCB; for details see analytical report No. 11L00413)
- Lot/batch No.: 2011285
- Stability under test conditions: The stability of the test item under storage conditions over the test period was guaranteed by the sponsor, and
the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
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
- Age at study initiation: Approx. 8 - 9 months
- Weight at study initiation: 4.21 kg – 4.49 kg
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): fully air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: The test patch was secured in position with a semi-occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol® and Lutrol® / water (1 : 1).
- Time after start of exposure: after 4 hours of exposure
SCORING SYSTEM: as described in OECD 404 guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 1.8
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: mean individual scores of the animals: 1.3 in 1/3 animals, 2 in 2/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0.4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: mean individual scores of the animals: 0 in 1/3 animals, 0.7 in 2/3 animals
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information according to CLP Criteria used for interpretation of results: EU
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