Registration Dossier
Registration Dossier
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EC number: 220-877-5 | CAS number: 2923-16-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 26 nov 1998 to 03 nov 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study not GLP, but following the OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Potassium trifluoroacetate
- EC Number:
- 220-877-5
- EC Name:
- Potassium trifluoroacetate
- Cas Number:
- 2923-16-2
- Molecular formula:
- C2HF3O2.K
- IUPAC Name:
- potassium trifluoroacetate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A
- Body weight: 2.7 kg
No more data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- sterile water
- Controls:
- no
- Amount / concentration applied:
- 500 mg aliquot mixed to a paste with 0.5 ml of sterile water.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 6.25 cm²
SCORING SYSTEM: According to EU and OECD guidelines criteria.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Other effects:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium trifluoroacetate is not irritating according to the CLP 1272/2008 criteria.
- Executive summary:
In a dermal irritation study (RTC, 2000), one New Zealand White rabbit was dermally exposed to 500 mg (mixed to a paste with 0.5 ml of sterile water) of potassium trifluoroacetate on dorsal surfaces of the trunk. Test sites were covered with semi-occlusive dressing for 4 hours. Animal was observed for 72 hours.
Irritation was scored according to the EU and OECD guidelines. Mean scores over 24, 48 and 72 hours were 0, 0 and 0 for erythema and 0, 0 and 0 for edema.
In this study, Potassium trifluoroacetate is not irritating when applied topically to rabbit, and not classified according to the CLP 1272/2008/EC criteria.
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