Lithium trifluoromethanesulphonate

Skin sensitisation

Administrative data

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.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

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).

Test material

Test material information

Constituent 1

Reference substance name:

bismuth;trifluoromethanesulfonate

Cas Number:

88189-03-1

Molecular formula:

C3BiF9O9S3

IUPAC Name:

bismuth;trifluoromethanesulfonate

Test material form:

solid: particulate/powder

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

In vivo test system

Test animals

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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

water

Concentration / amount:

0.5%

Induction 2

Route:

intradermal

Vehicle:

other: Freund's Complete Adjuvant

Concentration / amount:

50%

Induction 3

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

Challenge

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

Results and discussion

In vivo (non-LLNA)

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.