Registration Dossier
Registration Dossier
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EC number: 942-166-5 | CAS number: -
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: well performed Guideline Study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- EC Number:
- 942-166-5
- Cas Number:
- 922708-02-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Esterification products of glycerol with docosanoic acid, icosanedioic acid and 16-methylheptadecanoic acid
- Reference substance name:
- Glyceryl Behenate/Isostearate/Eicosadioate
- IUPAC Name:
- Glyceryl Behenate/Isostearate/Eicosadioate
- Test material form:
- solid: pellets
- Details on test material:
- - Name of test material (as cited in study report): Nomcort SG
- Substance type: organic
- Physical state: solid
- Analytical purity: not given
- Lot/batch No.: L060725
- Expiration date of the lot/batch: Jul. 25, 2009
- Stability under test conditions: not stated
- Storage condition of test material: room temperature, air tight
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Yonam College of Agricultur
- Age at study initiation: 17 weeks
- Weight at study initiation: 2.04 - 2.37 kg
- Housing: individual
- Diet: purina experimental diet for rabbits ad libitum
- Water: filtered and sterilized Drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 - 21.6
- Humidity (%): 42.2 - 64.1
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: patch, silk techs surgical tape and soft cloth tape with liner
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: 4 hours
SCORING SYSTEM: as described in Guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: over all observation time points
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No signs of irritation (erythema and edema) where observed in any animal at any time point
- Other effects:
- no other effects
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of irritation/corrosion were observed in this study. Therefore Nomcort SG was not a skin irritant under the conditions of this study.
- Executive summary:
This study was conducted to evaluate the effects on skin irritation of the test substance, Nomort SG, in 17 weeks old male NZW (Yac:NZW (KBL)) rabbits.
As a result, in 1, 24, 48 and 72 hours after the patch removal, there was no skin irritation in all animals for the initial and confirmatory tests. Primary skin irritation index was recorded as 0. In conclusion it was evaluated as "non irritant" in accordance with Draize's method.
Abnormal clinical signs and body weight changes by the test substance were not observed in all animals during the observation period.
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