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Description of key information

The Reaction mass of TFSK/TFAK did not induce skin sensitization in the Buehler test performed according to OECD Guideline 406 and GLP.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Jul 2018 to 28 Jan 2019
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
2016-05-30
Type of study:
Buehler test
Justification for non-LLNA method:
Prefered method for the legislation for which this study was run.
Species:
guinea pig
Strain:
Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Beijing Vital River Laboratory Animal Technology Co., Ltd
- Age at study initiation: 5-7 weeks
- Weight at study initiation: 280-384 g
- Housing: Plastic cage, < 12 animals
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Purified water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.7 - 25.2 °C
- Humidity (%): 41 - 65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Sep 2018 To: 8 Nov 2018
Details on study design:
RANGE FINDING TESTS:
Preliminary irritation test: 0.3 ml were applied to the skin of two animals for 6h and then observed for 24h to verify the irritating potential of the substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h, residual item removed by cotton wool soaked in water
- Test groups: 1
- Control group: 1
- Site: left flank
- Frequency of applications: once per week for 3 weeks
- Duration: 3 weeks
- Concentrations: 100%, 0.3 ml

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6h, residual item removed by cotton wool soaked in water
- Test groups: 1
- Control group: 1
- Site: right flank
- Concentrations: 100%, 0.3 ml
- Evaluation (hr after challenge): 24h and 48h

OTHER:
Body weights were recorded on the day before first dosing and conclusion of the study.
Challenge controls:
Yes
Animals were dosed with 0.3 ml of the neat test item.
Positive control substance(s):
yes
Remarks:
2-Dinitrochlorobenzene (DNCB)
Positive control results:
16/20 (80%) animals with a positive reaction.
Severity index 1.05 after 24h and 0.85 after 48h.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
Treated Group
No. with + reactions:
16
Total no. in group:
20
Remarks on result:
positive indication of skin sensitisation
Remarks:
2,4-Dinitrochlorobenzene was used as positive control

- Preliminary test phase: No visible changes were found on the treated skin area of each animal observed.

- Induction phase: No visible changes were found on the treated skin area of each animal observed 24 and 48 hours after the first, second and third induction exposures.

- Body weight: The mean body weight of the treatment and control group showed an increasing trend.

- Mortality: No mortality was observed.

Interpretation of results:
GHS criteria not met
Conclusions:
When applied as a 100% solution, the test item did not induce positive reactions in any of treated animals (0/20) and control animals (0/10) 24 and 48h after exposure.
Executive summary:

In a GLP-compliant OECD Guideline 406 study, the skin sensitisation properties of the test item Reaction mass of potassium trifluoroacetate and potassium trifluoromethanesulphinate were studied in guinea pig by using the methods of Buehler.

The concentrations of the test item used in the main study were determined on the basis of the results obtained from a preliminary screening test (maximum concentration tested: 100%). The main sensitisation test was undertaken using a test group of 20 animals and a control group of 10 animals. In an attempt to induce sensitisation, test animals were treated by topical application of the undiluted test item. This was repeated at weekly intervals for a total of 3 weeks (Day 0, first induction, Day 7 and Day 14). Animals of the control group were not treated. Two weeks after the third and final induction exposure, animals of the test and control groups were challenged by topical application of the test item at the same concentration used for induction. At challenge no response was observed to the test item, in either test or control group animals.

No evidence was obtained that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. Based on these results the test item is not regarded as a skin sensitizer according to the recommendations made in the test guidelines. It does not have to be classified for sensitization by skin contact according to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A reliable skin sensitization study, performed according to OECD Guideline 406 and GLP is available for the Reaction mass of TFSK/TFAK. In this study, the skin sensitisation potential of the Reaction mass of TFSK/TFAK was studied in guinea pig by using the methods of Buehler. The concentrations of the test item used were based on the results of a preliminary study. In the main study, one test group of 20 animals was treated by topical application of the undiluted test substance (30% reaction mass of TFSK/TFAK in water) and a control group of 10 animals remained untreated. The same treatment was repeated at weekly intervals for a total of 3 weeks (Day 0, first induction, Day 7 and Day 14). Two weeks after the third and final induction exposure, animals of the test and control groups were challenged by topical application of the test item at the same concentration used for induction. At challenge no response was observed to the test item, in either test or control group animals. No evidence was obtained that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. Based on these results the test item is not considered as a skin sensitizer according to the recommendations made in the test guidelines.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The Reaction mass of TFSK/TFAK did not show skin sensitising properties in a guinea pig Buehler test. For this reason, the reaction mass is considered not sensitizing, according to the CLP 1272/2008 regulation and GHS criteria.