Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study completed to GLP

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
EC Number:
403-500-0
EC Name:
A mixture of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate; thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
403-500-0
Constituent 2
Reference substance name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate
IUPAC Name:
reaction mass of: bis[4-diphenylsulfoniumphenyl]sulfide-bishexafluoroantimonate and thiophenoxyphenylsulfonium hexafluoroantimonate
Details on test material:
Nature of substance: liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca 140 mg

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Observation period (in vivo):
24,48,72 hrs
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
1.7
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
1.3
Max. score:
2
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24,48,72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24,48,72 hrs
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24,48,72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hrs
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Irritant / corrosive response data:
Conjunctivae score (redness):
Max score : 2, Max duration: 72h, Max value at end of observation period: 0 (related to all animals)
Chemosis score:
Max score : 1, Max duration: 48h, Max value at end of observation period: 0 (related to all animals)
Changes fully reversible within 14 days
Other effects:
Maximum scores of grade 2 conjunctival erythema and grade 1 conjunctival oedema observed for all three animals for 24-48 hours respectively.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is non irritant and non corrosive
Executive summary:

Due to the lack of information provided by ECHA, it is difficult to assess this end point fully. It appears from information provided that the substance has low irritation.