Methanetrisulphonic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from Authoritative data base

Data source

Reference

Reference 1

Reference Type:

other: Authoritative data base

Title:

skin sensitization for Methane Sulfonic Acid (CAS No: 75-75-2)

Author:

U.S. National Library of Medicine

Year:

2017

Bibliographic source:

HSDB (Hazardous Substances Data Bank); US national Library of Medicine reviewed by SRC

Reference 2

Reference Type:

secondary source

Title:

Skin Sensitization Study of Methane Sulfonic Acid (CAS No: 75-75-2)

Author:

U.S. Environmental Protection Agency

Year:

2017

Bibliographic source:

High Production Volume (HPV) Challenge Program; 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A Buehler Test was conducted on male and female Hartley guinea pigs for test chemical Methane Sulfonic Acid (CAS No: 75-75-2) to assess the skin sensitization effects caused by the chemical.

GLP compliance:

not specified

Type of study:

Buehler test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Methanesulphonic acid

EC Number:

200-898-6

EC Name:

Methanesulphonic acid

Cas Number:

75-75-2

Molecular formula:

CH4O3S

IUPAC Name:

methanesulfonic acid

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Methane sulfonic acid
- Molecular formula: CH4O3S
- Molecular weight: 96.1056 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: S(=O)(=O)(C)O
- InChI: 1S/CH4O3S/c1-5(2,3)4/h1H3,(H,2,3,4)

Specific details on test material used for the study:

- Name of test material (as cited in study report): Methane sulfonic acid
- Molecular formula: CH4O3S
- Molecular weight: 96.1056 g/mol
- Substance type: organic
- Physical state: liquid
- Smiles: S(=O)(=O)(C)O
- InChI: 1S/CH4O3S/c1-5(2,3)4/h1H3,(H,2,3,4)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

-Source: Harlan Sprague Dawley (P.O. Box 29176, Indianapolis, Indiana 46229)
-Age: no data
-Weight at study initiation: 429.6 ± 18.8 (males), 400.5 ± 27.6g (females)

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

water

Concentration / amount:

50% of methane sulfonic acid 70% solution (i.e. 35% of methane sulfonic acid)

Day(s)/duration:

14 days

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, open

Vehicle:

water

Concentration / amount:

25% of methane sulfonic acid 70% solution (i.e. 17.5% of methane sulfonic acid).

Day(s)/duration:

24 hours

Adequacy of challenge:

not specified

No. of animals per dose:

20 (10 males + 10 females)
10 (5 males + 5 females)

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20
- Control group:10
- Site: left shoulder
- Frequency of applications:
- Duration: 14 days
- Concentrations: 50% (0.03ml)

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: On day 28
- Exposure period: 24 hours
- Test groups:20
- Control group:10
- Site: right flank
- Concentrations: 25% (0.03ml)
- Evaluation (hr after challenge): after 24 hours

Challenge controls:

es concurrent vehicle.

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

25% (0.03ml)

No. with + reactions:

0

Total no. in group:

25

Clinical observations:

None of the test animals responded with a skin grade that would have been suggestive of sensitization.

Remarks on result:

positive indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:

None of the test animals responded with a skin grade that would have been suggestive of sensitization.

Any other information on results incl. tables

A preliminary study was conducted in order to determine the concentrations to be tested in the main study.

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Conclusions:

The test material Methane Sulfonic Acid (CAS No: 75-75-2) was considered to be not sensitizing on skin of 20 guinea-pigs when induced by 50% of methane sulfonic acid 70% solution (i.e. 35% of methane sulfonic acid) and challenged by 25% of methane sulfonic acid 70% solution (i.e. 17.5% of methane sulfonic acid).

Executive summary:

A Buehler Test was conducted on male and female Hartley guinea pigs for test chemical Methane Sulfonic Acid (CAS No: 75-75-2) to assess the skin sensitization effects caused by the chemical.

A preliminary study was conducted in order to determine the concentrations to be tested in the main study.

 

In sensitization study, the animals were induced topically with 0.3 ml of test substance (treated group) or with the vehicle (control group) on the left shoulder at concentration of 50% of methane sulfonic acid 70% solution (i.e. 35% of methane sulfonic acid) on day 1.On day 7, the same region received another topical application and on day 14, this same site was treated by a last topical application All these applications lasted approximately 6 hours.

 

Induction frequency was three applications in 14 days, followed by a 24 hour challenge treatment on day 28 at concentration of 25% of methane sulfonic acid 70% solution (i.e. 17.5% of methane sulfonic acid).

 

 

None of the test animals responded with a skin grade that would have been suggestive of sensitization. Hence The test materialMethane Sulfonic Acid (CAS No: 75-75-2) was considered to be not sensitizing onskin of 20 guinea-pigs.