Registration Dossier

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

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

Constituent 1
Chemical structure
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 1stday ,7thdays and on 14thdays 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.