Registration Dossier
Registration Dossier
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EC number: 943-665-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was conducted between 20 October 2015 and 23 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Constituent 1
- Specific details on test material used for the study:
- Lot/Batch PW"
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc., Denver, PA, USA
- Age at study initiation: ~28 wks
- Weight at study initiation: 2.8-3.1 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g per site
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit): 1.5 ml
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight):
- Concentration (if solution): - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3; 2 male 1 female
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentel washing with distilled water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24 48 and 72 hours
SCORING SYSTEM:
- Method of calculation: Draze Technique
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0.42h
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0.42h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No dermal irritant effects
Any other information on results incl. tables
Very slight Erythema in one rabbit at 1h time point, no erythema or edema effects seen in any other animlas at any time point
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a dermal irritant
- Conclusions:
- RD 14153 is not a dermal irritant
- Executive summary:
RD 14153 is not a dermal irritant
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