Registration Dossier
Registration Dossier
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EC number: 246-758-8 | CAS number: 25251-42-7
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 from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Skin sensitization study of Methanesulfonic acid was performed in guinea pig
- Author:
- HSDB
- Year:
- 2 017
- Bibliographic source:
- HSDB - Hazardous Substances Data Bank, 2017
- Reference Type:
- secondary source
- Title:
- Skin sensitization study of Methanesulfonic acid was performed in guinea pig
- Author:
- US EPA
- Year:
- 2 003
- Bibliographic source:
- High Production Volume Information System (HPVIS), 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of Methanesulfonic Acid was performed in guinea pig by Buehler Test
- GLP compliance:
- not specified
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- No data available
Test material
- 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 : 96.1056 g/mole
- Smiles notation (if other than submission substance): S(=O)(=O)(C)O
- InChl (if other than submission substance): 1S/CH4O3S/c1-5(2,3)4/ h1H3,(H,2,3,4)
- Structural formula attached as image file (if other than submission substance): see Fig. no data
- Substance type: organic
- Physical state: liquid
- Analytical purity: 70.3%
- Impurities (identity and concentrations): 29.7%
Constituent 1
- 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 : 96.1056 g/mole
- Smiles notation (if other than submission substance): S(=O)(=O)(C)O
- InChl (if other than submission substance): 1S/CH4O3S/c1-5(2,3)4/ h1H3,(H,2,3,4)
- Structural formula attached as image file (if other than submission substance): see Fig. no data
- Substance type: organic
- Physical state: liquid
- Analytical purity: 70.3%
- Impurities (identity and concentrations): 29.7%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: ATOFINA, Paris-La Défense,France
- 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
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- 50%
- Day(s)/duration:
- 6hr
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24hr
- No. of animals per dose:
- Total :30
Treated group:20
Control group:10 - Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period:6hr
- Test groups:20
- Control group:10
- Site: on the left shoulder
- Frequency of applications: on day 1,7 and 14
- Duration: 14 days
- Concentrations: 0.3ml of 50 % test substance
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: on 28 day after 1st induction
- Exposure period: 24hr
- Test groups:20
- Control group:10
- Site: right flank.
- Concentrations: 0.3 ml of the test
substance at the concentration of 25%
- Evaluation (hr after challenge): 24hr
OTHER: -Grading system:
0: no reaction
±: slight, patch y erythema
1: slight but confluent or moderate
patchy erythema
2: moderate erythema
3: severe erythema with or without
oedema.
-Pilot study: Yes - Challenge controls:
- yes
- Positive control substance(s):
- not specified
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:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No skin sensitization reaction was observed
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Sensitizing
- Conclusions:
- The skin sensitization study of Methanesulfonic Acid (75-75-2) was performed by Buehler test was considered to be not skin sensitizing in guinea pig .
- Executive summary:
The skin sensitization study of Methanesulfonic Acid (75-75-2)was performed by Buehlertestin 20Male and female Hartley guinea pigs.. An additional 10 animals served as the vehicle control group; a positive control group was not included in the study. Doses were selected on the bases of preliminary study.In induction phase, 3 induction given using concentration 0.3ml of 50 % test substance in water by epidermal open application for 6 hr at shoulder region on day 1,7 and 14.In challenge phase, 0.3 ml test substance of 25 % concentration in same vehicle used for challenge dose. Test material expose for 24hr onright flank. Evolution done 24 hr after challenge application. 0: no reaction,±: slight, patch y erythema,1: slight but confluent or moderate, patchy erythema,2: moderate erythema,3: severe erythema with or without oedema as grading system used .No skin sensitizing reaction observed after challenge application. Hence it is considered that Methanesulfonic Acid (75-75-2)was performed by Buehler test was considered to be not skin sensitizing in guinea pig.
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