Registration Dossier
Registration Dossier
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EC number: 220-877-5 | CAS number: 2923-16-2
Endpoint summary
Administrative data
Description of key information
Based on the results of the avaible studies, potassium trifluoroacetate is not considered as irritating to the skin or eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- 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 - 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. - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye 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
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- only one animal was tested
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A
- Weight at study initiation: 3 kg
No more data - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- SCORING SYSTEM: acoording to EU and OECD guidelines
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- on 1 animal
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Potassium trifluoroacetate is not irritating according to the CLP 1272/2008/EC criteria.
- Executive summary:
In an eye irritation study (RTC, 2000), one New Zealand White rabbit was exposed to 100 mg of potassium trifluoroacetate instilled into the conjunctival sac of the right eye. The left eye served as control.
Animal was observed for 7 days.
Irritation was scored by the method according to the OECD and EU guideline criteria. Mean scores were calculated for 24, 48 and 72 hours. Results were 0.33 for chemosis, 0.33 for redness of the conjunctivae, 0 for iris lesions and 0 for corneal opacity. Symptoms were fully reversible within 48 hours.
In this study, Potassium trifluoroacetate was not irritating according to the CLP 1272/2008/EC criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
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. The animal was observed for 72 hours. In this study, Potassium trifluoroacetate is not irritating when applied topically to rabbit, and not classified according to the CLP 1272/2008/EC criteria.
Eyes
In an eye irritation study (RTC, 2000), one New Zealand White rabbit was exposed to 100 mg of potassium trifluoroacetate instilled into the conjunctival sac of the right eye. The left eye served as control. The animal was observed for 7 days. In this study, Potassium trifluoroacetate was not irritating according to the CLP 1272/2008/EC criteria.
Justification for classification or non-classification
Based on the results observed in the available studies, no classification is required for irritation according to the CLP 1272/2008 regulation criteria.
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