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EC number: 200-898-6 | CAS number: 75-75-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.76 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 242 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- not necessary: based on no systemic effects at the highest dose in sub acute inhalation study
- AF for dose response relationship:
- 1
- Justification:
- already considered in route to route
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already considered in route to route
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- Justification:
- 3 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: according to german official authority risk assessment
- Overall assessment factor (AF):
- 36
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 2
- Justification:
- 2 for LOAEL to NAEL translation due to dose response relation
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already considered in route to route
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- Justification:
- 3 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19.44 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no necessary: based on no systemic effects at the highest dose in OECD 421 study
- AF for dose response relationship:
- 1
- Justification:
- already considered in route to route
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- AS rat according to ECHA guideance
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- Justification:
- 3 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Relevant Toxicology Data:
Methane sulphonic acid (MSA)is moderately toxic by oral and dermal exposure. It was not mutagenic and did not induce chromosomal changes. In a repeated dose toxicity study by inhalation exposure, a transient reduction in mean body weight gain and some microscopic findings in the nasal turbinates were the only adverse findings. The LOAEL for local effects was 25 mg/m3 (nominal) and the NOAEL for systemic toxicity was 242 mg/m3(analytical). In a reproductive screening test, no effects for parental toxicity, reproductive performance and on progency were observed up to the highest dosage tested (1000 mg/kg/day). No birth abnormalities were observed in the offsprings of rats given a dosage of 400 mg/kg/day during days 6 through 15 of pregnancy.
Processing the DNEL
- Identification of the most relevant dose descriptor:
The 28-days inhalation toxicity study in rats with MSA was considered to be the appropriate study for DNEL derivation – inhalation effects (see DNEL / OEL derivation for local effects). Additionally,reproductive screening test (OECD 421) in ratswas considered to be the appropriate study for DNEL derivation – oral and dermal effects.In this study, rats were dosed orally with MSA for 42 days in males and at least 54 days in females, which is considered equivalent to sub-acute repeated dose study.
- Mode of action:
MSA is corrosive; No mutagenic potential is apparent with MSA.
Derivation of DNELs
- DNEL derivation – inhalation (official german OEL available)
The german national authority (BAuA) has shortly published an official german OEL (Arbeitsplatzgrenzwert). The AGW (Arbeitsplatzgrenzwert, transl. occupational exposure level (OEL)) was defined as
0,7 mg/m3
with an exceedance factor of 1.
The rational for this value was given as follows (see chapter 13, page 9): ”Methan sulfonic acid is a local effective substance. In a subacute inhalation toxicity study with rats no NOAEL could be determined. Already for the lowest tested concentration of 25mg/m3local effects in nasal cavity were observed (hyperplasia of goblet cells and degeneration of olfactory epithelia). Hyperplasia of goblet cells is judged as adaptive and less critical than degeneration of olfactory epithelia.
Point of departure for AGW derivation is the LOAEL of 25 mg/m3. As in the sub acute inhalation toxicity study no NOAEL could be determined and extrapolation from LOAEL to NAEL using an extrapolation factor of 2 is performed. This extrapolation factor is considered as sufficient despite the low slope of the dose response curve of the olfactory ephithelia degeneration, as the effect is minimal marked. For time extrapolation (sub acute – chronic) the standard factor of 6 is used as no substance specific information concerning this extrapolation are available. As the critical toxicity is caused by the acidity based on the direct local cytotoxicity, an assessment factor of 3 is used for inter- and intra-species variability.
Take together AGW (OEL) of 0,7mg/m3for methan sulfonic acid is calculated based on a LOAEL of 25mg/m3”
Using the assessment factors of: 2 for LOAEL to NAEL translation, 6 for sub acute to chronic time extrapolation and 3 for inter- and intra-species variability. SUM AF = 36
LOAEL to NAEL translation as well as time extrapolation are in accordance with ECHA guidance factors, whereas inter / intra species variability is in accordance to ECETOC guidance.
- DNEL derivation – oral and dermal effects
As for oral and dermal effects no official values are available, the DNELs were derived using the following assumptions/assessmentfactors according to the same guideances used in the official german value.
- Selection of the dose descriptor:
Oral route /dermal systemic exposure:reproductive screening test in rats, NOAEL (systemic effects) = 1000 mg/kg bw.
- Modification of dose descriptor:
In order to adjust the NOAEL for the other/relevant exposures, a modification has to be made for workers.
Dermal/systemic exposure
Oral NOAEL |
Absorption difference |
Factor for study length |
Corrected NOAEL |
1000 mg/kg/day |
1 |
7 days/5days |
1400 mg/kg bw/d |
- Application of assessment factors:Assessment factors described in ECETOC (2003) Technical Report No. 86 and ECHA guideance:
Assessment factor-accounting for Differences in |
Default Value systemic effects |
Default value local effects |
|
Interspecies |
Correction for differences in metabolic rate per body weight |
4 * |
- |
Remaining differences |
1 |
1 |
|
Intraspecies |
Worker (ECETOC) |
3 |
3 |
Exposure duration |
Subacute to chronic (ECHA) |
6 |
6 |
Dose-response |
1 |
1 |
|
Quality of whole database |
1 |
1 |
* For oral/ dermal route
Inhalation route / systemic exposure
Inhalation NOAEC
|
Factor for study length |
Factor for standard respiratory volume man and 8-h exposure |
Corrected NOAEC |
242 mg/m3 |
6 h/8 h |
6.7 m3(8h) / 10 m3(8h) |
121.6 mg/ m3 |
Corrected NOAEC |
Sum of assessment factors applicable |
DNELinhalative |
121.6 mg/ m3 |
3 x 6 = 18 |
6.76 mg/m3 |
Dermal route/systemic exposure
Corrected NOAEL
|
Sum of assessment factors applicable |
DNELdermal |
1400 mg/kg bw/day |
4 x 3 x 6 =72 |
19.44 mg/kg bw |
- Resulting DNELs
Exposure pattern |
DNEL |
Acute inhalation – systemic effects |
- |
Acute dermal – local effects |
- |
Acute inhalation – local effects |
- |
Long-term dermal – systemic effects |
19.44 mg/kg |
Long-term inhalation – systemic effects |
6.76 mg/m3 |
Long-term oral – systemic effects |
NA |
Long-term dermal – local effects |
- |
Long-term inhalation – local effects |
0.7 mg/m3 |
NA: not applicable
v
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.44 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no necessary: based on no systemic effects at the highest dose in sub acute inhalation study
- AF for dose response relationship:
- 1
- Justification:
- already considered in route to route
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already considered in route to route
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- 5 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 60
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 2
- Justification:
- 2 for LOAEL to NAEL translation due to dose response relation (BAuA)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already considered in route to route
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- 5 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no necessary: based on no systemic effects at the highest dose in oral OECD 421 study
- AF for dose response relationship:
- 1
- Justification:
- already considered in route to route
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- AS rat according to ECHA guideance
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- 5 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECHA and ECETOC guideance (following offical BAUA approach)
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no necessary: based on no systemic effects at the highest dose in oral OECD 421 study
- AF for dose response relationship:
- 1
- Justification:
- already considered no route to route transfer
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic according to ECHA guideance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- AS rat according to ECHA guideance
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- 5 for inter- and intra-species variability according to ECETOC / mechanism of action
- AF for the quality of the whole database:
- 1
- Justification:
- quality ok, no RA, according to ECHA guideance
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC (BAuA)
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Relevant Toxicology Data:Same as shown in workers
Processing the DNEL
- Identification and selection of dose descriptor: Same as shown in workers
- Modificationof dose descriptor:
In order to adjust the NOAEL for the other/relevant exposures, a modification has to be made for workers and the general public.
Inhalation NOAEC |
Factor for study length |
Corrected NOAEC |
242 mg/m3 |
6 h/24 h (5 days/7 days) |
43.2 mg/ m3 |
Inhalation/local exposure
Inhalation LOAEC
|
Factor for extrapolation from LOAEC to NOAEC |
Corrected NOAEC |
25 mg/m3 |
2 (same like in BAuA riskassessment) |
12.5 mg/ m3 |
- Application of assessment factors:Assessment factors described in ECETOC (2003) Technical Report No. 86 and ECHA guideance were used. Ecetoc factors which are already used by the local german authority are used as they are based on mechanism of action.
Assessment factor-accounting for Differences in |
Default Value systemic effects |
Default value local effects |
|
Interspecies |
Correction for differences in metabolic rate per body weight |
4 * |
- |
Remaining differences (ECETOC, BAuA) |
1 |
1 |
|
Intraspecies |
General population (ECETOC, BAuA) |
5 |
5 |
Exposure duration |
Subacute to chronic (ECHA) |
6 |
6 |
Dose-response |
1 |
1 |
|
Quality of whole database |
1 |
1 |
* For oral/ dermal route
Oral Route / systemic exposure
Corrected NOAEL |
Sum of assessment factors applicable |
DNELoral |
1000 mg/kg bw/day |
4 x 5 x 6 =120 |
8.33 mg/kg bw
|
Inhalation route / systemic exposure
Corrected NOAEC |
Sum of assessment factors applicable |
DNELinhalative |
43.2 mg/ m3 |
5 x 6 = 30 |
1.44 mg/m3 |
Inhalation route DNELs / local exposure
Corrected NOAEC
|
Sum of assessment factors applicable |
DNELinhalative |
12.5 mg/m3 |
6 x 5 = 30 |
0.42 mg/m3 |
Dermal route/systemic exposure
Corrected NOAEL
|
Sum of assessment factors applicable |
DNELdermal |
1000 mg/kg bw/day |
4 x 5 x 6 =120 |
8.33 mg/kg bw
|
Resulting DNELs
Exposure pattern |
DNEL |
Acute inhalation – systemic effects |
- |
Acute dermal – local effects |
- |
Acute inhalation – local effects |
- |
Long-term dermal – systemic effects |
8.33 mg/kg |
Long-term inhalation – systemic effects |
1.44 mg/m3 |
Long-term oral – systemic effects |
8.33 mg/kg |
Long-term dermal – local effects |
- |
Long-term inhalation – local effects |
0.42 mg/m3 |
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