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Diss Factsheets

Administrative data

Description of key information

No sensitisation effect was observed in a guinea-pig maximisation test (OECD 406).

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:
supporting study
Study period:
from 2000-02-28 to 2003-08-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Remarks:
Non-GLP study performed similarly to OECD guideline No. 406 (screening test), no detail on the animal and environmental conditions.
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
: screening tets, no detail on the animal and environmental conditions.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Remarks:
screening test
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An in vivo LLNA method in not necessary since data from an in vivo guinea pig maximisation test are available. In addition, the substance is classified corrosive.
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: no data
- Weight at study initiation: no data
- Fasting period before study: not required
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data
Route:
intradermal and epicutaneous
Vehicle:
water
Remarks:
sterile
Concentration / amount:
Induction: intradermal injection: 0.1%: topical application: 10%
Challenge: 1%
Route:
other: epicutaneous
Vehicle:
water
Remarks:
sterile
Concentration / amount:
Induction: intradermal injection: 0.1%: topical application: 10%
Challenge: 1%
No. of animals per dose:
5 animals for the test group
3 animals for the control group
Details on study design:
RANGE FINDING TESTS: One animal was exposed by intradermal injection to the test item at different concentrations (from 0.1 to 10%) and the signs of skin irritancy were observed 6 days after the exposure. Two other animals were exposed by topical application to the test item at different concentrations (from 1 to 30%) and the signs of skin irritancy were analysed 7 days following the exposure. See results of the range findings study in Tables 7.4.1/1 and 7.4.1/2.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: no data
- Test groups: For the intradermal and topical exposure: 3 sites of application on each animal: Freund's complete adjuvant (FCA), Test item in water, Test item in FCA. For the topical application, the animals were pre-treated with sodium lauryl sulphate to promote an irritant reaction and then exposed as explained just before.
- Control group: For the intradermal and topical exposure: 3 sites of application on each animal: Freund's complete adjuvant (FCA), water only , water + FCA. For the topical application, the animals were pre-treated with sodium lauryl sulphate to promote an irritant reaction and then exposed as explained just before.
- Site: no data
- Frequency of applications: the topical application was performed one week following the intradermal injection. Single exposure in each case.
- Duration: no data
- Concentrations: 0.1% for the intradermal injection, 10% for the topical application

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Two weeks after the second induction stage, ie. 21 days after the first induction stage
- Exposure period: no data
- Test groups: topical application of the test item in water
- Control group: topical application of water only
- Site: no data
- Concentrations: 1%
- Evaluation (hr after challenge): 24 and 48hrs
Positive control substance(s):
no
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no data
Key result
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
Key result
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
Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test item trifluoromethanesulfonic acid (triflic acid) is not classified as Skin sensitiser according to the criteria of the Regulation (EC) 1272/2008 (CLP) and of the annex VI of the Directive 67/548/EEC.
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 trifluoromethanesulfonic acid (triflic acid) 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. Six days after an intradermal injection, the test item from 1% to 10% induced necrosis of the skin. At 0.1 and 0.5% of test item erythema was observed. The concentration of 0.1% was chosen for the first induction stage as only a slight erythema reaction was observed (score 1). Seven days after a topical application of sodium lauryl sulphate (to promote the skin irritation) followed by a topical application of the test item diluted in water, no signs of irritation was observed at 1and 5%. At 10% a slight irritation was observed, therefore this concentration was chosen for the second induction stage.

In the main study performed on 5 animals for the test group and 3 animals for the control group, three test sites were tested in each animal. 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 10% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (1%) 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 trifluoromethanesulfonic acid (triflic acid) is not classified as skin sensitiser according to the criteria of the Regulation (EC) 1272/2008 (CLP) and of the annex VI of the Directive 67/548/EEC.

This study is considered as acceptable as it satisfies the criteria of the OECD guideline No.406 (screening test).

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

One study was available and was identified as a key study (reliability 2 according to Klimisch reliability). This study was performed similarly to the OECD No. 406 (screening test, non GLP) (Longobardi, 2003). Dunkin-Hartley guinea pigs were exposed to trifluoromethanesulphonic acid 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. Six days after an intradermal injection, the test item from 1% to 10% induced necrosis of the skin. At 0.1 and 0.5% of test item erythema was observed. The concentration of 0.1% was chosen for the first induction stage as only a slight erythema reaction was observed (score 1). Seven days after a topical application of sodium lauryl sulphate (to promote the skin irritation) followed by a topical application of the test item diluted in water, no signs of irritation were observed at 1and 5%. At 10% a slight irritation was observed, therefore this concentration was chosen for the second induction stage.

In the main study performed on 5 animals for the test group and 3 animals for the control group, three test sites were tested in each animal. 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 10% in sterile water. Two weeks following this second induction stage, animals were challenged by a topical application of the test item (1%) 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, trifluoromethanesulphonic acid is considered as not a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

Based on the classification criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP), and given the absence of positive reactions in a guinea-pig maximisation test (screening test), trifluoromethanesulphonic acid is not classified as a skin sensitizer.

Respiratory sensitisation:

No data available. Therefore, no classification is possible due to lack of data.