Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.