Registration Dossier
Registration Dossier
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EC number: 471-170-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- This test pre-dates the in vitro study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 9-August 12, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: done under GLP and OECD method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Test material form:
- liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source:David Percival Ltd. , UK- Age at study initiation: 12 to 20 weeks old- Weight at study initiation: 2.5 to 3.5 kg- Housing: individualy housed in suspended cagess- Diet (e.g. ad libitum): certified rabbit food, free access- Water (e.g. ad libitum): main drinking water, free access- Acclimation period: 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 17-23 C- Humidity (%): 30-70%- Air changes (per hr): 15 ACH- Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: August 09 2005 To: August 12, 2005
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hour
- Observation period:
- 1 , 24, 48 and 72 hrs after removal of patch
- Number of animals:
- 3
- Details on study design:
- standard design according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other: total scored at 24 & 72 hrs divided by six
- Time point:
- other: 24 & 72 hrs
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- no data
- Irritant / corrosive response data:
- There was no sign of dermal effects.
- Other effects:
- Ph test substance determined to be 6.0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritiation index of 0.0 to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
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