Registration Dossier

Administrative data

Endpoint:
eye 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 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only one animal was used
GLP compliance:
no

Test material

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

Test animals / tissue source

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: 3.2 kg
No more information available.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the other eye served as reference.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
1 hour
Number of animals or in vitro replicates:
1
Details on study design:
A 100 mg aliquot of the test substance was introduced into the right eye of a single animal by gently pulling away the lower lid from the eyeball to form a cup into which the test substance was placed. The lids were then held shut for a few seconds to prevent loss of the test substance. The left eye remained untreted.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 1 hour

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 hour
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: the animal was humanely killed
Other effects:
Response assessed immediately after dosing. Immediately after dosing extreme corneal opacity was apparent and the animal was humanely killed.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
TFSIH causes severe eye damage.
Executive summary:

In a study (2000), bis trifluoromethanesulfonamide was introced in the eye of one rabbit.

Immediately after dosing extreme corneal opacity was apparent and the animal was humanely killed.

In these conditions test item causes irreversible eye damage and classified eye damage category 1 (H318), according to the CLP 1272/2008.