Registration Dossier
Registration Dossier
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EC number: 926-191-9 | CAS number: 1181221-96-4
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:
- 2 013
- Report date:
- 2013
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:
- iGloss Crosslinker (ZQ54-2211)
- IUPAC Name:
- iGloss Crosslinker (ZQ54-2211)
- Details on test material:
- - Name of test material (as cited in study report): iGloss Crosslinker (ZQ54-2211)
- Physical state: Liquid (highly viscous)/ yellowish, clear
- Analytical purity: Mn 1200 Da; Mw 1800 Da; PDI 1.5; Relative RI-area of compounds with M 250-500 Da: 1.7% and with M 250-1000 Da: 29.1%; determined with Gel Permeation Chromatography
- Lot/batch No.: 294222
- Storage condition of test material: Room temperature; no direct sunlight; protect against humidity
- Other: The test item was 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
- Age at study initiation: Approx. 5-6 months
- Weight at study initiation: 4.63 kg – 4.87 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: for at least 5 days before application
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): in fully air-conditioned rooms
- 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: 4h
SCORING SYSTEM: according to 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:
- 0.7
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: individual mean scores: 0.7 in 3/3 animals
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24/48/72 hours
- Score:
- 0
- Reversibility:
- other: no effects observed
Any other information on results incl. tables
Very slight erythema (grade 1) was observed in one out of three
animal immediately after removal of the patch and persisted up to hour
48.
In two out of three animals very slight erythema (grade 1) was observed
from hour 48 until hour 72 or until study day 7, respectively.
Additionally in these animals scaling was noted from hour 48 until hour
72 or until study day 14, respectively.
The cutaneous reactions, with the exception of scaling, were reversible in one animal within 14 days after removal of the patch. In another animal the cutaneous reactions were reversible within 72 hours and in the third animal within 7 days after removal of the patch.
Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.7 and 0.7 for erythema and 0.0, 0.0 and 0.0 for edema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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