Registration Dossier

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:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal tested
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals 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.