Sulphoacetic acid

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data from secondary literature

Data source

Reference

Reference Type:

secondary source

Title:

Skin sensitization test of Methanesulfonic acid was performed by Buehler Test in guinea pig

Author:

US EPA

Year:

2016

Bibliographic source:

High Production Volume Information System (HPVIS), 2016

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Principles of method if other than guideline:

Skin sensitization study of Methanesulfonic acid was performed by Buehler test in guinea pig.

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:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Methanesulfonic acid
- Molecular formula: CH4O3S
- Molecular weight: 96.10g/mole
- Substance type: Organic
- Physical state: : No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material (as cited in study report): Methanesulfonic acid
- Molecular formula: CH4O3S
- Molecular weight: 96.10g/mole
- Substance type: Organic
- Physical state: : No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available

In vivo test system

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

male/female

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Harlan Sprague Dawley (P.O.
Box 29176, Indianapolis, Indiana
46229)
- Age at study initiation: No data available
- Weight at study initiation: 429.6 ± 18.8(males), 400.5 ± 27.6g (females)
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, open

Vehicle:

water

Concentration / amount:

0.3 ml of 50 % occlusive epicutaneous

Day(s)/duration:

14 days

Challenge

No.:

#1

Route:

epicutaneous, open

Vehicle:

water

Concentration / amount:

0.3 ml of 25 % occlusive epicutaneous

Day(s)/duration:

24h

No. of animals per dose:

Total :30
Test group :10 male ,10 female
Control group :5 male ,5 female

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three ,on day 1st ,7th and 14th
- Exposure period:6 hr
- Test groups:20
- Control group:10
- Site: left shoulder
- Frequency of applications: after 7 days
- Duration: 14 days
- Concentrations: 0.3 ml of 50 % occlusive epicutaneous


B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge:14 days
- Exposure period:24hr
- Test groups:20
- Control group:10
- Site: right flank
- Concentrations: 0.3 ml of 25 % occlusive epicutaneous
- Evaluation (hr after challenge):24hr

OTHER: Freunds Complete Adjuvant (FCA) not used

Challenge controls:

No data available

Positive control substance(s):

not required

Study design: in vivo (LLNA)

Statistics:

No data available

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.3 ml of 25 % occlusive epicutaneous

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

No indication of skin sensitization

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: Not sensitizing

Remarks:

No skin sensitization reaction noted

Conclusions:

The Methanesulfonic acid (75-75-2) was considered to be not sensitizing to guinea pig.

Executive summary:

The skin sensitizing study of Methanesulfonic acid was carried out in Hartley guinea pig in group of 20 by Buehler test method.. Vehicle control group 5 animals /sex also observed .Pilot study done before start of experiment. Test material dissolved in water .Topical induction was by application of test substance 0.3 ml of 50 % occlusive epicutaneous for 6 hours on left shoulder for 3 times in 14 days on 1^stday ,7^thdays and on 14^thdays An interval of 14 days animals challenged by 0.3 ml of 25 % occlusive epicutaneouspatch for 24 hours. Cutaneous reactions were evaluated at 24 hours.After challenge no skin reactions were observed. Therefore, based on the results obtained, the Methanesulfonic acid (75 -75 -2) was considered to be non-sensitizing to skin of guinea pig.