Registration Dossier
Registration Dossier
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EC number: 435-300-4 | CAS number: 82113-65-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Simplified study not GLP, following standardised guidelines.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
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:
- yes
- Remarks:
- only one animal tested
- GLP compliance:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 435-300-4
- EC Name:
- -
- Cas Number:
- 82113-65-3
- Molecular formula:
- C2HNO4F6S2
- IUPAC Name:
- 1,1,1-trifluoro-N-trifluoromethanesulfonylmethanesulfonamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
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
No more data.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 0.5 g aliquot of test item was mixed to a paste with 0.5 mL of sterile water and sread evenly over a gauze square measuring 2.5 x 2.5 cm.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm.
SCORING SYSTEM: Draize (EU)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- TFSIH is not irritating to skin.
- Executive summary:
In a study (2000), 0.5 g of Bis trifluoromethanesulfonimide was applied on the trunk on one rabbit for 4 hours, under semiocclusive conditions.
The treated area was examined for 72 hours.
Mean scores at 24, 48 and 72 hours were 0 for edema and 0 for erythema respectively.
Under these conditions, TFSIH is not classified according to the CLP 1272/2008 criteria.
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