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Toxicological information

Skin sensitisation

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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:
2017
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:
2003
Bibliographic source:
High Production Volume Information System (HPVIS), 2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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%

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 group
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.