Methanesulfonamide, 1,1,1-trifluoro-N-[(trifluoromethyl)sulfonyl]-

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Simplified study not GLP, following standardised guidelines.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

less animals than recommended in the guideline were used

GLP compliance:

no

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

435-300-4

EC Name:

-

Cas Number:

82113-65-3

Molecular formula:

C2HNO4F6S2

IUPAC Name:

1,1,1-trifluoro-N-trifluoromethanesulfonylmethanesulfonamide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Harlan Nossan S.r.l., Italy
No more information available.

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

polyethylene glycol

Induction 2

Concentration / amount:

Induction 1% in polyethyleneglycol 400

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

polyethylene glycol

Challenge 2

Concentration / amount:

Induction 1% in polyethyleneglycol 400

No. of animals per dose:

3 in the control group
5 in the test group

Details on study design:

RANGE FINDING TESTS:
In a preliminary screening test, necrosis was evident by intradermal injection of the tets substance up to a concentration 0.5% and slight irritation (score of 1) was observed after topical application at a concentration of 25%.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 1 week (1st induction) and 2 weeks (2nd induction).
- Test groups: 1
- Control group: only vehicles
- Frequency of applications: second induction 1 week after the first one.
- Duration: 3 weeks
- Concentrations: 1% in polyethylene 400 and 1% in FCA emulsion for intradermal injection. 25% in petrolatum for topical application.

B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 2weeks after the second induction.
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Concentrations: 10% in petrolatum (1st challenge); 1% in petrolatum (re-challenge)
- Evaluation (hr after challenge):

Animals were allocated to treatment to give a test group of 5 animals and a control group of 3. In an attempt to induce sensitization, test animals were intradermally injected with an emulsion of FCA and the test substance in both the selected vehicle and FCA emulsion.
One week later this was boosted by topical application of the test substance over the injection sites. Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance.
Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. Irritation to the test substance was noted and challenge was repeated 1 week later using the test substance at lower concentration.

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

10% in petrolatum

No. with + reactions:

0

Total no. in group:

5

Clinical observations:

Swelling of treated skin; desqamation from skin surface

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Swelling of treated skin; desqamation from skin surface.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

1% in petrolatum

No. with + reactions:

0

Total no. in group:

5

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

Results:

1st challenge
Control group
Animal Number	Reaction at challenge
	24 hours	48 hours
93	1	1
95	1	1
97	1	1s
Test group
Animal number	Reaction at challenge
	24 hours	48 hours
99	1ds	2n
101	1ds	2n
103	1s	2t
105	1s	2t
107	1s	1

 (s) Swelling of treated skin; (d) desqamation from skin surface; (t) Thickening of treated skin

 

2nd challenge
Control group
Animal Number	Reaction at challenge
	24 hours	48 hours
93	0	0
95	0	0
97	0	0
Test group
Animal number	Reaction at challenge
	24 hours	48 hours
99	0	0
101	0	0
103	0	0
105	0	0
107	0	0

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

TFSIH is not sensitizing.

Executive summary:

In a study (2000), animals were allocated to treatment to give a test group of 5 animals and a control group of 3 animals. In an attempt to induce sensitisation, test animals were intradermally injected with an emulsion of Freund's complete adjuvant and the test substance in both the selected vehicle and an emulsion of Freund's complete adjuvant. One week later this was boosted by topical application of the test substance over the injection sites.

Control group animals were treated in the same manner but the selected vehicle was used in place of the test substance. Two weeks after the second induction stage, all animals were challenged by topical application of both the vehicle and the test substance. Irritation to the test substance was noted and challenge was repeated 1 week later using the test substance at a lower concentration.

The concentrations of the test substance used were determined by preliminary screening tests, in which necrosis was evident by intradermal injection of the test substance up to a concentration 0.5% and a slight irritation (score of 1) was observed after topical application at a concentration of 25%.

These results indicate that the test substance does not elicit a sensitisation response in the guinea pig, there being no evidence of reaction at challenge following a period of induction exposure to the substance.