Registration Dossier
Registration Dossier
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EC number: 251-528-5 | CAS number: 33454-82-9
Endpoint summary
Administrative data
Description of key information
Skin sensitisation: no skin sensitisation study was performed on Lithium trifluoromethanesulfonate.
Lithium ion is not a skin sensitizer as confirmed by the official European classification (index number 003-001-00-4).
Five skin sensitization studies are available on other trifluoromethanesulfonate salts. These studies were all unequivocally negative.
- Bismuth trifluoromethanesulfonate: simplified, non GLP, guinea pig maximization test (OECD 406): negative for skin sensitization.
- Potassium trifluoromethanesulfonate:simplified, non GLP, guinea pig maximization test (OECD 406): negative for skin sensitization.
- Ytterbium trifluoromethanesulfonate: simplified, non GLP, guinea pig maximization test (OECD 406): negative for skin sensitization.
- Lanthane trifluoromethanesulfonate: simplified, non GLP, local lymph node assay (OECD 429): negative for skin sensitization
- Magnesium trifluoromethansulfonate: simplified, non GLP, local lymph node assay (OECD 429): negative for skin sensitization.
Respiratory sensitisation: no specific study was available.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 28-February-2000 to 19-August-2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 406 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals in treated groups / 3 animals in control group / Only two intradermal injection during the induction phase
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before Reach regulation ((EC) No. 1907/2006).
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature, under a dry inert atmosphere - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l.
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.5%
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 50%
- Route:
- other: Topical application / Second induction stage
- Vehicle:
- water
- Concentration / amount:
- 60%
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with SDS
- No.:
- #1
- Route:
- other: Topical application
- Vehicle:
- water
- Concentration / amount:
- 30%
- No. of animals per dose:
- 5 animals in the test group
3 animals in the control group - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the maximisation test in Guinea pig did not show any evidence of reaction at challenge. Therefore, the test item, bismuth triflate, should not be considered as a skin sensitizer.
- Executive summary:
In a non-GLP skin sensitisation study performed similarly to the OECD No. 406 (screening test), Dunkin-Hartley guinea pigs were exposed to bismuth triflate diluted in sterile water (vehicle). In a preliminary study the skin irritation potential of the test item was assessed in one animal after an intradermal injection with Freund’s complete adjuvant and on two animals following a topical application in order to determine the concentrations of test item used in the main study.
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (50%) with FCA, or of the test item (0.5%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (30%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions, the test item, bismuth triflate, should not be considered as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 01-September-2004 to 10-January-2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 429 and EU Method B.42 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- No positive control and historical of positive control not included in appendix / 3 animals per group
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 29 April 2004
- Deviations:
- yes
- Remarks:
- No positive control and historical of positive control not included in appendix / 3 animals per group
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature and protected from humidity - Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 18 to 25 g within a range of +/-20% of the mean body weight
- Housing: Animals were housed individually in disposable crystal polystyrene cages (22.0 cm x 8.5 cm x 8.0 cm). Each cage contained (except for the 5 hours following the 3H-TdR injections) autoclaved sawdust (SICSA, Alfortville, France). Sawdust was analyzed by the supplier for composition and contaminant levels.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
- IN-LIFE DATES:
- Experimental starting date (prreliminary test): 23 May 2006
- First day of treatment (main test): 07 June 2006
- Experimental completion date: 12 June 2006 - Vehicle:
- dimethylformamide
- Concentration:
- Main test: 0, 10, 25 and 50%
- No. of animals per dose:
- Main test: 3 females per group (3 treated groups and 1 negative control group)
- Key result
- Parameter:
- SI
- Value:
- 0
- Variability:
- 0.00
- Test group / Remarks:
- Negative control group (Dimethylformamide)
- Key result
- Parameter:
- SI
- Value:
- 1.83
- Variability:
- -1.30
- Test group / Remarks:
- ACILYS TA-La 10%
- Remarks on result:
- other: Slightly irritant
- Key result
- Parameter:
- SI
- Value:
- 1.5
- Variability:
- 10.53
- Test group / Remarks:
- ACILYS TA-La 25%
- Remarks on result:
- other: Slightly irritant
- Key result
- Parameter:
- SI
- Value:
- 1.43
- Variability:
- 1.37
- Test group / Remarks:
- ACILYS TA-La 50%
- Remarks on result:
- other: Slightly irritant
- Cellular proliferation data / Observations:
- SYSTEMIC CLINICAL SIGNS AND MORTALITY
No mortality and no clinical signs were observed during the study.
LOCAL IRRITATION
A dryness of the skin of the ears was noted on day 6 in all females treated at the concentration of 25 and 50%.
An increase in ear thickness (+23%) was noted in only 1/3 females treated with the test item at the concentration of 25%. In comparison with the other values, this probably corresponds to an individual variation which it is difficult to interpret precisely.
No noteworthy increase in ear thickness was observed in the animals of the other treated groups.
PROLIFERATION ASSAY
No noteworthy lymphoproliferation and no dose-response relationship were noted at the tested concentrations. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions and according to the LLNA method, the test item ACILYS TA-La (trifluoromethanesulfonate de lanthane) should not be considered as a skin sensitizer.
- Executive summary:
The potential of the test item ACILYS TA-La (trifluoromethanesulfonate de lanthane) to induce delayed contact hypersensitivity was determined using the murine Local Lymph Node Assay (LLNA), according to a protocol similar to OECD Guideline 429 and EU Method B.42. The highest practicable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50% (v/v).
In the main assay, twenty female CBA/J mice were allocated to four groups of three animals each:
- three groups received test sample (formulated in dimethylformamide) at 50, 25 and 10 % (v/v) concentrations,
- the negative control group received the vehicle (dimethylformamide).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were usedtocalculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study. A dryness of the skin of the ears was noted on day 6 in all females treated at the concentration of 25 and 50%. No noteworthy increase in ear thickness was observed in the animals of the other treated groups. No treatment related effects were observed on the body weight changes of the experimental animals.
The stimulation index values were 1.43, 1.50 and 1.83 at concentrations of 50, 25 and 10 % (v/v), respectively.
In conclusion, under the experimental conditions and according to the LLNA method, the test item ACILTYS TA-La (trifluoromethanesulfonate de Lanthane) should not be considered as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 01-September-2004 to 07-February-2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 429 and EU Method B.42 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- No positive control and historical of positive control not included in appendix / 3 animals per group
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 29 April 2004
- Deviations:
- yes
- Remarks:
- No positive control and historical of positive control not included in appendix / 3 animals per group
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature and protected from humidity - Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 18 to 25 g within a range of +/-20% of the mean body weight
- Housing: Animals were housed individually in disposable crystal polystyrene cages (22.0 cm x 8.5 cm x 8.0 cm). Each cage contained (except for the 5 hours following the 3H-TdR injections) autoclaved sawdust (SICSA, Alfortville, France). Sawdust was analyzed by the supplier for composition and contaminant levels.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
- IN-LIFE DATES:
- Experimental starting date: 15 June 2006
- Experimental completion date: 20 June 2006 - Vehicle:
- dimethylformamide
- Concentration:
- Main test: 0, 10, 25 and 50%
- No. of animals per dose:
- Main test: 3 females per group (3 treated groups and 1 negative control group)
- Key result
- Parameter:
- SI
- Value:
- 0
- Variability:
- -2.82
- Test group / Remarks:
- Negative control group (Dimethylformamide)
- Key result
- Parameter:
- SI
- Value:
- 2
- Variability:
- -1.33
- Test group / Remarks:
- ACILYS TA-Mg 10%
- Remarks on result:
- other: Non-irritant
- Key result
- Parameter:
- SI
- Value:
- 1.27
- Variability:
- 1.37
- Test group / Remarks:
- ACILYS TA-Mg 25%
- Remarks on result:
- other: Non-irritant
- Key result
- Parameter:
- SI
- Value:
- 0.98
- Variability:
- 0.00
- Test group / Remarks:
- ACILYS TA-Mg 50%
- Remarks on result:
- other: Non-irritant
- Cellular proliferation data / Observations:
- SYSTEMIC CLINICAL SIGNS AND MORTALITY
No mortality and no clinical signs were observed during the study.
LOCAL IRRITATION
No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the other treated groups.
PROLIFERATION ASSAY
No significant lymphoproliferation was noted at any tested concentrations. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions and according to the LLNA method, the test item ACILYS TA-Mg (trifluoromethanesulfonate de magnésium) did not induce delayed contact hypersensitivity.
According to the results obtained in this simplified study, without any positive control group, the test item should not be classified as sensitizing to the skin. - Executive summary:
The potential of the test item ACILYS TA-Mg (trifluoromethanesulfonate de Magnésium) to induce delayed contact hypersensitivity was determined using the murine Local Lymph Node Assay (LLNA), according to a protocol similar to OECD Guideline 429 and EU Method B.42. The highest practicable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50% (v/v).
In the main assay, twenty female CBA/J mice were allocated to four groups of three animals each:
- three groups received test sample (formulated in dimethylformamide) at 50, 25 and 10 % (v/v) concentrations,
- the negative control group received the vehicle (dimethylformamide).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were usedtocalculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study. No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the other treated groups. No significant lymphoproliferation was noted at any tested concentrations.
The stimulation index values were 0.98, 1.27 and 2.00 at concentrations of 50, 25 and 10 % (v/v), respectively.
In conclusion, under the experimental conditions and according to the LLNA method, the test item ACILYS TA-Mg (trifluoromethanesulfonate de magnésium) did not induce delayed contact hypersensitivity. According to the results obtained in this simplified study, without any positive control group, the test item should not be classified as sensitizing to the skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 26-November-1998 to 27-March-2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 406 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals in treated groups / 3 animals in control group / Only two intradermal injection during the induction phase
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before Reach regulation ((EC) No. 1907/2006).
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5%
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 5%
- Route:
- other: Topical application / Second induction stage
- Vehicle:
- water
- Concentration / amount:
- 60%
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with SDS
- No.:
- #1
- Route:
- other: Topical application
- Vehicle:
- water
- Concentration / amount:
- 10%
- No. of animals per dose:
- 5 animals in the test group
3 animals in the control group - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the maximisation test in Guinea pig did not show any evidence of reaction at challenge. Therefore, the test item, potassium triflate, should not be considered as a skin sensitizer.
- Executive summary:
In a non-GLP skin sensitisation study performed similarly to the OECD No. 406 (screening test), Dunkin-Hartley guinea pigs were exposed to potassium triflate diluted in sterile water (vehicle). In a preliminary study the skin irritation potential of the test item was assessed in one animal after an intradermal injection with Freund’s complete adjuvant and on two animals following a topical application in order to determine the concentrations of test item used in the main study.
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (5%) with FCA, or of the test item (5%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (10%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions, the test item, potassium triflate, should not be considered as a skin sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 28-February-2000 to 18-May-2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Well documented study according to OECD TG 406 performed by trusted laboratory. However, since the study was a simplified study and not performed under GLP conditions, the Klimisch score is 2.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- 5 animals in treated groups / 3 animals in control group / Only two intradermal injection during the induction phase
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was performed before Reach regulation ((EC) No. 1907/2006).
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient conditions, protected from humidity - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
- Age at study initiation: Not specified
- Weight at study initiation: Not specified
- Housing: Not specified
- Diet (e.g. ad libitum): Not specified
- Water (e.g. ad libitum): Not specified
- Acclimation period: Not specified
- Indication of any skin lesions: Not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not specified
- Humidity (%): Not specified
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): Not specified - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1%
- Route:
- intradermal
- Vehicle:
- other: Freund's Complete Adjuvant
- Concentration / amount:
- 0.1%
- Route:
- other: Topical application / Second induction stage
- Vehicle:
- water
- Concentration / amount:
- 60%
- Adequacy of induction:
- other: non-irritant substance, but skin pre-treated with SDS
- No.:
- #1
- Route:
- other: Topical application
- Vehicle:
- water
- Concentration / amount:
- 10%
- No. of animals per dose:
- 5 animals in the test group
3 animals in the control group - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- -
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No data
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the maximisation test in Guinea pig did not show any evidence of reaction at challenge. Therefore, the test item, ytterbium triflate, should not be considered as a skin sensitizer.
- Executive summary:
In a non-GLP skin sensitisation study performed similarly to the OECD No. 406 (screening test), Dunkin-Hartley guinea pigs were exposed to ytterbium triflate diluted in sterile water (vehicle). In a preliminary study the skin irritation potential of the test item was assessed in one animal after an intradermal injection with Freund’s complete adjuvant and on two animals following a topical application in order to determine the concentrations of test item used in the main study.
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (0.1%) with FCA, or of the test item (0.1%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (10%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions, the test item, ytterbium triflate, should not be considered as a skin sensitizer.
- Endpoint:
- skin sensitisation, other
- Remarks:
- Based on both LLNA and GPMT assays
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- See attached justification document
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- other: Global evaluation
- Remarks on result:
- no indication of skin sensitisation
- Parameter:
- SI
- Value:
- < 3
- Remarks on result:
- other: See remarks
- Remarks:
- Negative
Referenceopen allclose all
Preliminary screens
This following table details the results of examination of injection sites 6 days after intradermal injection of a range of concentrations of the test item.
| Animal number | Test item concentration |
Erythema | Additional comments |
| 281 | 50% 20% 10% 5% 1% 0.5% |
- - - - - 2 |
Necrosis Necrosis Necrosis Necrosis Necrosis None |
This following table details the results of examination of treated sites following topical application of a range of concentrations of the test item.
| Animal number | Observation time | Test item concentration | |||
| 60% | 30% | 10% | 5% | ||
| 285 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
| 287 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
Preliminary test
Following the solubility assay (Acetone/olive oil (4/1, v/v): emultion at 10% concentration; Dimethylformamide: solution at 50% maximal contration tested), dimethylformamide was chosen as vehicle and the concentrations selected for the preliminary test were 5, 10, 25 and 50%. Since the test item was non-irritant, the highest concentration retained for the main test was the maximal practicable concentration (50%).
Study results
Treatment and concentrations |
Cell count | Viability (%) |
Amount of cells (x 106 cells) |
Cellularity index |
Number of nodes per group |
dpm per group |
dpm per node |
Stimulation index (SI) |
Increase in ear thickness (% between dat 1 and day 6) |
Irritation level |
|
| viable | dead | ||||||||||
DMF 0 |
85 | 5 | 94.44 | 4.25 | 6 | 613.45 | 102.24 | 0.00 | |||
ACITYL TA-La 10% |
123 | 14 | 89.78 | 6.15 | 1.45 | 6 | 1121.84 | 186.97 | 1.83 | -1.30 | II |
ACITYL TA-La 25% |
215 | 39 | 84.65 | 10.75 | 2.53 | 6 | 922.43 | 153.74 | 1.50 | 10.53 | |
ACITYL TA-La 50% |
150 | 31 | 82.87 | 7.50 | 1.76 | 6 | 876.61 | 146.10 | 1.43 | 1.37 | |
DMF: dimethylformamide
dpm: desintegration per minute
viability = [viable cells / (viable cells + dead cells)] x 100
cellularity index = amount of cells (x106 cells) in treated group / amount of cells (x106cells) in the control group
stimulation index = dpm of treated group / dpm of control group
Ear thickness measurements (mm)
| Groups | Animals | Days | ||||||
| 1 | 2 | d1 | 3 | d2 | 6 | d3 | ||
DMF 0 |
61 | 0.25 | 0.25 |
0.00 | 0.25 | 0.00 | 0.26 | 0.01 |
| 62 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.24 | -0.01 | |
| 63 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| M | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| SD | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.00 | |
| % (*) | 0.00 | 0.00 | 0.00 | |||||
ACILYS TA-La 10% |
64 | 0.26 | 0.25 | -0.01 | 0.26 | 0.00 | 0.24 | -0.02 |
| 65 | 0.25 | 0.25 | 0.00 | 0.26 | 0.01 | 0.27 | 0.02 | |
| 66 | 0.26 | 0.25 | -0.01 | 0.26 | 0.00 | 0.25 | -0.01 | |
| M | 0.26 | 0.25 | -0.01 | 0.26 | 0.00 | 0.25 | 0.00 | |
| SD | 0.01 | 0.00 | 0.01 | 0.00 | 0.01 | 0.02 | 0.02 | |
| % (*) | -2.60 | 1.30 | -1.30 | |||||
ACILYS TA-La 25% |
67 | 0.26 | 0.26 | 0.00 | 0.26 | 0.00 | 0.32 | 0.06 |
| 68 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.26 | 0.01 | |
| 69 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.26 | 0.01 | |
| M | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.28 | 0.03 | |
| SD | 0.01 | 0.01 | 0.00 | 0.01 | 0.00 | 0.03 | 0.03 | |
| % (*) | 0.00 | 0.00 | 10.53 | |||||
ACILYS TA-La 50% |
70 | 0.25 | 0.25 | 0.00 | 0.26 | 0.01 | 0.25 | 0.00 |
| 71 | 0.24 | 0.24 | 0.00 | 0.26 | 0.02 | 0.24 | 0.00 | |
| 72 | 0.24 | 0.24 | 0.00 | 0.25 | 0.01 | 0.25 | 0.01 | |
| M | 0.24 | 0.24 | 0.00 | 0.26 | 0.01 | 0.25 | 0.00 | |
| SD | 0.01 | 0.01 | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | |
| % (*) | 0.00 | 5.48 | 1.37 | |||||
M: mean
SD: standard deviation
(*): percentage of ear thickness increase compared to day 1
d1: difference of ear thickness between day 2 and day 1
d2: difference of ear thickness between day 3 and day 1
d3: difference of ear thickness between day 6 and day 1
DMF: dimethylformamide
Preliminary test
Following the solubility assay (Acetone/olive oil (4/1, v/v): emultion at 10% concentration; Dimethylformamide: solution at 50% maximal contration tested), dimethylformamide was chosen as vehicle and the concentrations selected for the preliminary test were 25 and 50%. Since the test item was non-irritant, the highest concentration retained for the main test was the maximal practicable concentration (50%).
Study results
Treatment and concentrations |
Cell count | Viability (%) |
Amount of cells (x 106 cells) |
Cellularity index |
Number of nodes per group |
dpm per group |
dpm per node |
Stimulation index (SI) |
Increase in ear thickness (% between dat 1 and day 6) |
Irritation level |
|
| viable | dead | ||||||||||
DMF 0 |
44 | 2 | 95.65 | 2.20 | 6 | 231.66 | 38.61 | -2.82 | |||
ACITYL TA-Mg 10% |
86 | 15 | 85.15 | 4.30 | 1.95 | 6 | 463.76 | 77.29 | 2.00 | -1.33 | I |
ACITYL TA-Mg 25% |
68 | 6 | 91.89 | 3.40 | 1.55 | 6 | 293.83 | 48.97 | 1.27 | 1.37 | |
ACITYL TA-Mg 50% |
37 | 1 | 97.37 | 1.85 | 0.84 | 6 | 226.90 | 37.82 | 0.98 | 0.00 | |
DMF: dimethylformamide
dpm: desintegration per minute
viability = [viable cells / (viable cells + dead cells)] x 100
cellularity index = amount of cells (x106 cells) in treated group / amount of cells (x106cells) in the control group
stimulation index = dpm of treated group / dpm of control group
Ear thickness measurements (mm)
| Groups | Animals | Days | ||||||
| 1 | 2 | d1 | 3 | d2 | 6 | d3 | ||
DMF |
61 | 0.23 | 0.23 |
0.01 | 0.24 | 0.01 | 0.22 | -0.01 |
| 62 | 0.24 | 0.24 | 0.00 | 0.25 | 0.01 | 0.23 | -0.01 | |
| 63 | 0.24 | 0.25 | 0.01 | 0.25 | 0.01 | 0.24 | 0.00 | |
| M | 0.24 | 0.24 | 0.01 | 0.25 | 0.01 | 0.23 | -0.01 | |
| SD | 0.01 | 0.01 | 0.01 | 0.01 | 0.00 | 0.01 | 0.01 | |
| % (*) | 2.82 | 4.23 | -2.82 | |||||
ACILYS TA-Mg 10% |
64 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 |
| 65 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.24 | -0.01 | |
| 66 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| M | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| SD | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.01 | 0.01 | |
| % (*) | 0.00 | 0.00 | -1.33 | |||||
ACILYS TA-Mg 25% |
67 | 0.25 | 0.25 | 0.00 | 0.26 | 0.01 | 0.25 | 0.00 |
| 68 | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| 69 | 0.23 | 0.25 | 0.02 | 0.25 | 0.02 | 0.24 | 0.01 | |
| M | 0.24 | 0.25 | 0.01 | 0.25 | 0.01 | 0.25 | 0.00 | |
| SD | 0.01 | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | |
| % (*) | 2.74 | 4.11 | 1.37 | |||||
ACILYS TA-Mg 50% |
70 | 0.25 | 0.24 | -0.01 | 0.24 | -0.01 | 0.24 | -0.01 |
| 71 | 0.25 | 0.25 | 0.00 | 0.26 | 0.01 | 0.26 | 0.01 | |
| 72 | 0.25 | 0.26 | 0.01 | 0.26 | 0.01 | 0.25 | 0.00 | |
| M | 0.25 | 0.25 | 0.00 | 0.25 | 0.00 | 0.25 | 0.00 | |
| SD | 0.00 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | 0.01 | |
| % (*) | 0.00 | 1.33 | 0.00 | |||||
M: mean
SD: standard deviation
(*): percentage of ear thickness increase compared to day 1
d1: difference of ear thickness between day 2 and day 1
d2: difference of ear thickness between day 3 and day 1
d3: difference of ear thickness between day 6 and day 1
DMF: dimethylformamide
Preliminary screens
This following table details the results of examination of injection sites 6 days after intradermal injection of a range of concentrations of the test item.
| Animal number | Test item concentration |
Erythema | Additional comments |
179 |
60% 20% 10% 5% 1% 0.5% |
- - - 0 0 0 |
Necrosis Necrosis Necrosis None None None |
This following table details the results of examination of treated sites 7 days following topical application of a range of concentrations of the test item.
| Animal number | Observation time | Test item concentration | |||
| 60% | 30% | 10% | 5% | ||
| 181 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
| 183 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
Preliminary screens
This following table details the results of examination of injection sites 6 days after intradermal injection of a range of concentrations of the test item.
| Animal number | Test item concentration |
Erythema | Additional comments |
| 429 | 60% 20% 10% 5% 1% 0.5% |
- - - - - - |
Necrosis Necrosis Necrosis Necrosis Necrosis Necrosis |
This following table details the results of examination of treated sites following topical application of a range of concentrations of the test item.
| Animal number | Observation time | Test item concentration | |||
| 60% | 30% | 10% | 5% | ||
| 431 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
| 433 | 24 hours 48 hours |
0 0 |
0 0 |
0 0 |
0 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Details on the five studies performed on other trifluoromethane sulfonate salts:
Bismuth trifluoromethansulfonate :
The skin sensibilisation potential of bismuth triflate was assessed using a non-GLP Maximisation test performed in Dunkin-Hartley guinea pigs according to a protocol similar to the OECD No. 406 (screening test).
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (50%) with FCA, or of the test item (0.5%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (30%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions,the test item, bismuth triflate, should not be considered as a skin sensitizer.
Potassium trifluoromethansulfonate :
The skin sensibilisation potential of potassium triflate was assessed using a non-GLP Maximisation test performed in Dunkin-Hartley guinea pigs according to a protocol similar to the OECD No. 406 (screening test).
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (5%) with FCA, or of the test item (5%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (10%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions,the test item, potassium triflate, should not be considered as a skin sensitizer.
Ytterbium trifluoromethansulfonate :
The skin sensibilisation potential of ytterbium triflate was assessed using a non-GLP Maximisation test performed in Dunkin-Hartley guinea pigs according to a protocol similar to the OECD No. 406 (screening test).
In the main study performed on 5 animals for the test group and 3 animals for the control group. In the first induction stage intradermal injections of Freund’s complete adjuvant (FCA), or of the test item (0.1%) with FCA, or of the test item (0.1%) in vehicle were performed on each animal. One week later, the animals were pre-treated with sodium lauryl sulphate (to promote a skin irritation) and then topically exposed to the test item at 60% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (10%) in water. 24 and 48 hrs after the challenge, no skin reaction was observed in any animal of the test group or of the control group. The body weight gain was comparable in the test animals and the control animals.
In conclusion, under the test conditions,the test item, ytterbium triflate, should not be considered as a skin sensitizer.
Lanthane trifluoromethansulfonate :
The potential of the test item ACILYS TA-La (lanthane trifluoromethanesulfonate) to induce delayed contact hypersensitivity was determined using the murine Local Lymph Node Assay (LLNA), according to a protocol similar to OECD Guideline 429 and EU Method B.42. The highest practicable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50% (v/v).In the main assay, twenty female CBA/J mice were allocated to four groups of three animals each:
- three groups received test sample (formulated in dimethylformamide) at 50, 25 and 10 % (v/v) concentrations,
- the negative control group received the vehicle (dimethylformamide).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were usedtocalculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study.A dryness of the skin of the ears was noted on day 6 in all females treated at the concentration of 25 and 50%.No noteworthy increase in ear thickness was observed in the animals of the other treated groups.No treatment related effects were observed on the body weight changes of the experimental animals.The stimulation index values were 1.43, 1.50 and 1.83 at concentrations of 50, 25 and 10 % (v/v), respectively.
In conclusion, under the experimental conditions and according to the LLNA method, the test item ACILTYS TA-La (trifluoromethanesulfonate de Lanthane) should not be considered as a skin sensitizer.
Magnesium trifluoromethansulfonate :
The potential of the test item ACILYS TA-Mg (Magnesium trifluoromethanesulfonate) to induce delayed contact hypersensitivity was determined using the murine Local Lymph Node Assay (LLNA), according to a protocol similar to OECD Guideline 429 and EU Method B.42. The highest practicable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 50% (v/v).In the main assay, twenty female CBA/J mice were allocated to four groups of three animals each:
- three groups received test sample (formulated in dimethylformamide) at 50, 25 and 10 % (v/v) concentrations,
- the negative control group received the vehicle (dimethylformamide).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was measured by incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were usedtocalculate stimulation indices (SI).
No mortality or signs of systemic toxicity were observed during the study.No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the other treated groups. No significant lymphoproliferation was noted at any tested concentrations. The stimulation index values were 0.98, 1.27 and 2.00 at concentrations of 50, 25 and 10 % (v/v), respectively.
In conclusion, under the experimental conditions and according to the LLNA method, the test item ACILYS TA-Mg (trifluoromethanesulfonate de magnésium) did not induce delayed contact hypersensitivity. According to the results obtained in this simplified study, without any positive control group, the test item should not be classified as sensitizing to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
As Lithium trifluoromethanesulfonate is a salt composed of trifluoromethanesulfonate anion and Lithium cation, the skin sensitization potential is expected to be mediated independently by these two components.
No study about lithium is presented here but it is a well-known substance and Lithium potential to induce skin sensitization has been largely investigated. The Reach dossier (EC number 231-102-5) on this substance shows the absence of skin sensitization potential and there is even an European official classification (index number 003-001-00-4) showing that lithium is not a skin sensitizer.
For the trifluoromethanesulfonate ion, five skin sensitization studies are available on five other trifluoromethanesulfonate salt (Bismuth, lanthane, Magnesium, Potassium and Ytterbium trifluoromethansulfonates).
- Bismuth trifluoromethanesulfonate: A simplified, non GLP, guinea pig maximization test (OECD 406) is available. This test concludes clearly that this substance has no skin sensitization potential as no reaction was observed in any of the tested animals.
- Potassium trifluoromethanesulfonate: A simplified, non GLP, guinea pig maximization test (OECD 406) is available. This test concludes clearly that this substance has no skin sensitization potential as no reaction was observed in any of the tested animals.
- Ytterbium trifluoromethanesulfonate: A simplified, non GLP, guinea pig maximization test (OECD 406) is available. This test concludes clearly that this substance has no skin sensitization potential as no reaction was observed in any of the tested animals.
- Lanthane trifluoromethanesulfonate: A simplified, non GLP, local lymph node assay (OECD 429) is available. This test concludes clearly that this substance has no skin sensitization potential as observed stimulation index are clearly below three for all tested doses up to 50%.
- Magnesium trifluoromethanesulfonate: A simplified, non GLP, local lymph node assay (OECD 429) is available. This test concludes clearly that this substance has no skin sensitization potential as observed stimulation index are clearly below three for all tested doses up to 50%.
Based on the complete absence of skin sensitization reaction on any of the five tested trifluoromethanesulfonate salts, it can be concluded that trifluoromethanesulfonate ion has not skin sensitization potential.
Therefore, the above results are conclusively showing that neither of the two components of Lithium trifluoromethanesulfonate, Lithium ion nor trifluoromethanesulfonate ion have any potential to induce skin sensitization. It is then concluded that Lithium trifluoromethanesulfonate is not a skin sensitizer.
Consequently, Lithium trifluoromethanne sulfonate should not be classified for skin sensitisation according to regulation (CE) n°1272/2008.
No study are available for the respiratory sensitisation assessment. However, as Lithium trifluoromethanesulfonate is not a skin sensitizer, it is unlkely that there is potential for respiratory sensitization.
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