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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Jun 2018 to 10 Sep 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP Guideline study
Justification for type of information:
The in vivo data have been generated as part of a new substance notification in China for which this test is required to confirm negative in vitro data.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2017
Deviations:
yes
Remarks:
Six times points of humidity deviated with the highest value measured being 73%. Deviations were very short time periods. This does not affect the quality and integrity of the study.
GLP compliance:
yes (incl. QA statement)
Remarks:
2016-05-30

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate
EC Number:
911-467-3
Molecular formula:
C2O2F3K and CO2F3KS
IUPAC Name:
Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate
Constituent 2
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
Test material form:
liquid
Remarks:
Aqueous solution

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Qinqdao Kangda Biological Technology Limited Company
- Age at study initiation: ca. 95 days
- Weight at study initiation: 2076 - 2592 g
- Housing: Individually in suspended stainless wire cages
- Diet (e.g. ad libitum): Rabbit maintenant feed, ad libitum
- Water (e.g. ad libitum): Purified drinking water, ad libitum
- Acclimation period: at least 10 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9
- Humidity (%): 47 -73
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 15 June 2018 To: 29 June 2018

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM:
According to the OECD guideline

TOOL USED TO ASSESS SCORE: fluorescein (at 24h), binocular loupe for all time points.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no observable abnormalities for the three control eyes at all observations after dosing.
There was no retention of fluorescein for the three control and treated eyes 24h after dosing.
Other effects:
- Lesions and clinical observations: No significant adverse systemic effect was observed.

Any other information on results incl. tables

Individual scores - Observation time (hour) Mean scores 24-48-72h
1 24 48 72
Animal 1 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae redness 1 0 0 0 0
Conjunctivae chemosis 1 0 0 0 0
Animal 2 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae redness 1 0 0 0 0
Conjunctivae chemosis 0 0 0 0 0
Animal 3 Cornea 0 0 0 0 0
Iris 0 0 0 0 0
Conjunctivae redness 1 0 0 0 0
Conjunctivae chemosis 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The Reaction mass of TFSK/TFAK is not iritating to eyes.
Executive summary:

An eye irritation study was performed according to OECD TG 405 and under GLP conditions. An instillation of 0.1 ml of the test item in one eye of 3 rabbits was performed. One eye remained untreated and served as a control. No irreversible effects were noted. Based on the results above, the test material is not classified for eye irritation.