Registration Dossier
Registration Dossier
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EC number: 261-767-7 | CAS number: 59447-55-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09/04/2003-17/04/2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP comparable to OECD guideline
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- /
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- FR-1025M
- IUPAC Name:
- FR-1025M
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):FR1025-M
- Substance type: Monomer
- Physical state: white powder
- Lot/batch No.: 020313
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Perceval Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2-3.5 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17-23°C
- Humidity (%):30-70%
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light
Test system
- Type of coverage:
- other: in an elasticated corset
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 3minutes, 1 hour (for 1 rabbit) and 4 hours after application (for all)
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:on the back
- Type of wrap if used: cotton gauze patch, placed in position with a strip or surgical adhesive tape and wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 min, 1 hour, 4 hours
SCORING SYSTEM: Draize
Erythema and Eschar formation: 0-4
Oedema formation: 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- other: total
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 1 hour
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 24 hours
- Score:
- 3
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 48 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- other: total
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 8
- Irritant / corrosive response data:
4 -hour exposure: Very slight erythema and very slight oedema were noted at all treated skin sites one and 24 hours after patch removal. Very slight erythema persisted at one treated skin site at the 48-hour observation. Two treated skin sites appeared normal at the 48-hour observation and one treated skin site appeared normal at the 72-hour observation.
1 -hour exposure: No evidence of skin irritation was noted during the study.
3 -minute exposure period: No evidence of skin irritation was noted during the study.- Other effects:
- /
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 1.0 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC. - Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)
- Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
- United States Environmental Protection Agency Health Effects Test Guidelines OPPTS 870.2500 Acute Dermal Irritation August 1998 Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Two treated skin sites appeared normal at the 48-hour observation and one treated skin site appeared normal at the 72-hour observation. No corrosive effects were noted. 3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no evidence of skin irritation. Conclusion. The test material produced a primary irritation index of 1.0 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 2001/59/EC.
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