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EC number: 219-203-2 | CAS number: 2386-57-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
The sensisitizing potential of sodium methanesulfonate was evaluated using a study performed with the methanesulfonic acid. Considering the skin corrosive properties of the acid compared to the absence of skin irritation with the sodium salt, the study performed with the acid is a worst case for the evaluation of the salt.
The potential of 70% aqueous methane sulfonic acid, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler (Morris, 1995). 70% aqueous methane sulfonic acid was evaluated for primary irritation at levels of undiluted, 50%, 25%, 10%, 5%, 2.5%, 1%, and 0.5%. All formulations were prepared w/v in distilled water. Undiluted 70% aqueous methane sulfonic acid produced grades of 2, 1, and ± with edema, blanching, and scabbing on two sites, 50%, 25%, 10%, 5%, 2.5%, and 1% produced grades of ±, while 0.5% produced grades of ± and 0. A 50% w/v concentration of 70% aqueous methane sulfonic acid in distilled water was chosen for use at induction for the test group. This level was chosen as the highest concentration causing no greater than Mild to moderate primary irritation. Undiluted distilled water was utilized at induction for the vehicle control group. An 25% w/v concentration of 70% aqueous methane sulfonic acid in distilled water was chosen for use at primary challenge for the test group and the vehicle control group. This level was chosen as the highest concentration causing no more than slight primary irritation. None of the test animals or control animals responded with a skin grade that would have been suggestive of sensitization.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- This study was performed before the implementation of the REACH regulation.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ORGANISMS:
- Strain: Hartley
- Sex: male and female
- Source: Harlan Sprague Dawley (P.O. Box 29176, Indianapolis, Indiana 46229)
- Age: no data
- Weight at study initiation: 429.6 ± 18.8 (males), 400.5 ± 27.6g (females) - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 35%
- Day(s)/duration:
- days 1, 7 and 14
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 17.5%
- Day(s)/duration:
- Day 28
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 10 males and 10 females
Control group: 5 males and 5 females - Details on study design:
- ADMINISTRATION:
- Induction schedule:
- On day 1, dermal application with 0.3 ml of test substance (treated group) or with the vehicle (control group) on the left shoulder.
- On day 7, the same region received another topical application
- On day 14, this same site was treated by a last topical application
All these applications lasted approximately 6 hours.
- Concentration in Freunds Complete Adjuvant (FCA): not used here
- Challenge schedule: On day 28, all the animals received 0.3 ml of the test substance at the concentration of 25% (of the 70% solution) in their right flank.
- Challenge exposure duration : 24h
- Rechallenge: no
- Positive control: no
- Other:
EXAMINATIONS:
- Examination schedule: 24h after each induction an challenge application.
- Grading system:
0: no reaction
±: slight, patchy erythema
1: slight but confluent or moderate patchy erythema
2: moderate erythema
3: severe erythema with or without oedema.
- Pilot study: Yes
A preliminary study was conducted in order to determine the concentrations to be tested in the main study.
The irritation potential of methane sulfonic acid 70% at levels of undiluted, 50%, 25%, 10%, 5%, 2.5%, 1% and 0.5% was evaluated in two groups of four animals each. Four levels of test material were evaluated per animals.
Dilutions were obtained with distilled water (w/v).
0.3 ml of different solutions was applied into a 25 mm Hill Top Chamber, which were placed on animals clipped back for 6 hours. The day after, animals were depilated and two hours later, examined for irritation, according the previously described scale.
Another score was performed 40h after exposure. - Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
- Positive control results:
- alpha-Hexylcinnamaldehyde at 5% in acetone induced skin reactions of sensitization in 7/10 guine pigs
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 17.5% aqueous methane sulfonic acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 17.5% aqueous methane sulfonic acid. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 17.5% aqueous methane sulfonic acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 17.5% aqueous methane sulfonic acid. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 17.5% aqueous methane sulfonic acid
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 17.5% aqueous methane sulfonic acid. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 17.5% aqueous methane sulfonic acid
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 17.5% aqueous methane sulfonic acid. No with. + reactions: 0.0. Total no. in groups: 9.0.
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 20 guinea-pigs were induced by 50% of methane sulfonic acid 70% solution (i.e. 35% of methane sulfonic acid) and challenged by 25% of methane sulfonic acid 70% solution (i.e. 17.5% of methane sulfonic acid). None of the test animals responded with a skin grade that would have been suggestive of sensitization.
- Executive summary:
The potential of 70% aqueous methane sulfonic acid, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler. 70% aqueous methane sulfonic acid was evaluated for primary irritation at levels of undiluted, 50%, 25%, 10%, 5%, 2.5%, 1%, and 0.5%. All formulations were prepared w/v in distilled water. Undiluted 70% aqueous methane sulfonic acid produced grades of 2, 1, and ± with edema, blanching, and scabbing on two sites, 50%, 25%, 10%, 5%, 2.5%, and 1% produced grades of ±, while 0.5% produced grades of ± and 0. A 50% w/v concentration of 70% aqueous methane sulfonic acid in distilled water was chosen for use at induction for the test group. This level was chosen as the highest concentration causing no greater than Mild to moderate primary irritation. Undiluted distilled water was utilized at induction for the vehicle control group. An 25% w/v concentration of 70% aqueous methane sulfonic acid in distilled water was chosen for use at primary challenge for the test group and the vehicle control group. This level was chosen as the highest concentration causing no more than slight primary irritation. None of the test animals or control animals responded with a skin grade that would have been suggestive of sensitization.
Reference
RESULTS OF
PILOT STUDY:
Undiluted methane sulfonic acid 70% produced grades of 2, 1 and ±, with
oedema, blanching and scabbing on two sites.
Dilutions at 50%, 25%, 10%, 5%, 2.5% and 1% produced grades of ±, while
0.5% produced grades of ± and 0.
Consequently, the 50% dilution was chosen for use at induction for the
test group, since it caused no greater than mild to moderate primary
irritation. Moreover, the 25% dilution was selected for challenge,
because it caused no more than slight irritation.
RESULTS OF TEST
- Sensitization reaction: None of the test animals responded with a skin
grade that would have been suggestive of sensitization.
- Clinical signs: no data
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
No classification is warranted.
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