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Registration Dossier
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EC number: 829-719-5 | CAS number: 1190865-44-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2014-04-09 to 2014-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethanone
- EC Number:
- 829-719-5
- Cas Number:
- 1190865-44-1
- Molecular formula:
- C8H2Cl2F4O
- IUPAC Name:
- 1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethanone
Constituent 1
- Specific details on test material used for the study:
- Batch No.: CPFOA1301
Purity: 98.5%
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.74 kg
- Housing: individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Immediately following patch removal
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the trunk of the rabbit was wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing: any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours after application
OBSERVATION TIME POINTS
Immediately following removal of the patches
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score: 4, immediately following patch removal
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- Score 3, immediately following patch removal
- Irritant / corrosive response data:
- Grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema were noted in the treated skin site immediately after patch removal. The reactions were indicative of dermal corrosion.
The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The test item was classified as corrosive to rabbit skin (based on one animal).
- Executive summary:
The study was performed to assess the irritancy potential of the test item following a single, 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.
A single 4-Hour, semi occluded application of the test item to the intact skin of one rabbit produced grey/green colored dermal necrosis (attributed a Draize score of 4 for injuries in depth), surrounded by an area of dermal hemorrhage extending up to 30 mm beyond the test site, and moderate edema. The reactions were indicative of dermal corrosion.
The skin reactions were considered to be irreversible and indicative of full thickness tissue destruction, therefore, the animal was humanely killed immediately after the observation.
The test item was classified as corrosive to rabbit skin (based on one animal).
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