Registration Dossier
Registration Dossier
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EC number: 939-266-6 | CAS number: 1179883-13-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- not applicable, UVCB substance
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- not applicable, UVCB substance
- Reference substance name:
- 928-176-2
- EC Number:
- 928-176-2
- IUPAC Name:
- 928-176-2
- Details on test material:
- - Name of test material (as cited in study report): trade name given
- Physical state: white solid
- Analytical purity: 100% AS
- Composition of test material, percentage of components: 30% C16/C18-APG, 70% C16/C18 fatty alcohols
- Lot/batch No.: 9235138038
- Storage conditions: at room temperature, dark
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- other: Kleinrussen, Chbb: HM
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae GmbH, Biberach, Germany
- Age at study initiation: 16 months
- Weight at study initiation: 2.85 kg
- Housing: individually
- Diet: Ssniff rabbit diet K4 (Ssniff GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days (1 animal) and 14 days (2 animals)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: sheared
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g (moistened with 1 g distilled water) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h and 21 days - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: the adhesive gauze patch was held in place with a hypo-allergenic adhesive gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing: residual test substance was rinsed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- within 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- No further local or systemic effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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