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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Remarks:
- CIT Research Laboratories, France
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
- Details on test material:
- - Name of test material (as cited in study report): Methanesulfonic acid
- Physical state: colorless liquid
- Analytical purity: 70.50
- Composition of test material, percentage of components: Methanesulfonic acid 70 % in water
- Lot/batch No.: 4810A
- Storage condition of test material: keep hermetically closed, at room temperature, in a well ventilated place
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, L’Arbresle, France
- Age at study initiation: (P) 10 weeks
- Weight at study initiation: (P) Males: 408 g (350-441); Females: 241 g (211-267)
- Housing: single
- Diet (e.g. ad libitum): A04 C pelleted maintenance diet
- Water (e.g. ad libitum): bottles containing tap water
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±20
- Air changes (per hr): 12 cycles
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test item was administered as a solution in the vehicle in order to achieve concentrations of 25, 50 and 100 mg/mL, expressed as active substance. The dosage forms were adjusted to a pH of 7.0 with NaOH.
VEHICLE
- Concentration in vehicle: 25, 50 and 100 mg/mL
- Amount of vehicle (if gavage): 10 ml/kg bw - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: overnight
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Further matings after two unsuccessful attempts: yes (Each female was placed with the same male until mating occurred or 14 days had elapsed and the pre-coital time was calculated) - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Throughout the study, a satisfactory agreement was observed between the nominal and actual concentrations of the test item in the administered dosage forms, since the deviations from nominal concentration were in an acceptable range of ± 10%.
- Duration of treatment / exposure:
- males: 42 days (28 days pre-mating and 14 days mating period)
females: at least 54 days (28 days pre-mating, 1-14 days mating, 21-22 days pregnancy, 4 days lactation and 5 days post-natal period) - Frequency of treatment:
- daily
- Details on study schedule:
- - Age at mating of the mated animals in the study: ca. 15-16 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
250, 500 and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The dose-levels were selected on the basis of a 2-week toxicity study where no relevant signs of toxicity were observed at dose rates of 333, 666 or 1000 mg/kg bw/day.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Each animal was checked at least twice a day for mortality and signs of morbidity during the treatment period. Animals found dead were subjected to a macroscopic post-mortem examination. Each animal was observed at least once a day, at approximately the same time for the recording of clinical signs.
BODY WEIGHT: Yes
- Time schedule for examinations: The body weight of each male was recorded on the first day of treatment (day 1), then once a week until sacrifice. The body weight of each female was recorded on the first day of treatment (day 1), then once a week until mated, then on days 0, 7, 14 and 20 post-coitum and on days 1 and 4 post-partum.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined: The quantity of food consumed by each male was recorded once a week from the first day of treatment (except during the mating period) until sacrifice. The quantity of food consumed by each female was recorded once a week during the pre-mating period and then on the following intervals: days 0-7, 7-14, 14-20 post-coitum, and days 1-4 post-partum. No food consumption was recorded for the females during the mating period. - Litter observations:
- PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities
GROSS EXAMINATION OF DEAD PUPS: yes, for external and internal abnormalities; possible cause of death was determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals [after the end of the mating period]
- Maternal animals: All surviving animals [on day 5 post-partum, females which had not delivered on day 25 post-coitum were sacrificed after day 25 post-coitum, and females which did not mate were sacrificed at least 1 week after the end of the mating period]. In all females, the number of implantation sites and corpora lutea were recorded. In addition, in the females which did not mate or did not deliver, the implantation sites were classified, whenever appropriate, as scars, early resorptions, late resorptions, live fetuses or dead fetuses. Furthermore, in the females which did not mate or were apparently non-pregnant, the presence of implantation scars on the uterus was checked using the ammonium sulphide staining technique.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera with special attention paid to the reproductive organs.
HISTOPATHOLOGY / ORGAN WEIGHTS
The following tissues were prepared for microscopic examination: epididymides, ovaries, prostate, seminal vesicles, testes, uterus (horns and cervix), vagina. A microscopic examination was performed on the ovaries, testes and epididymides (with special emphasis on stages of spermatogenesis and histopathology of interstitial testicular cell structure) of all males and females in the control and high-dose groups. The body weights of the males were recorded before sacrifice and the testes and epididymides were weighed wet separately as soon as possible after dissection. The ratio of organ weight to body weight (recorded immediately before sacrifice) was calculated. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed on day 5 post-partum.
GROSS NECROPSY
- A gross external examination before sacrifice was performed on all pups including those that died during lactation. There was no preservation of tissues. - Statistics:
- Mean values were compared by one-way analysis of variance and Dunnett test. Percentage values were compared by the Fisher exact probability test.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): The body weight change of all treated animals was unaffected by treatment. The food consumption of all the treated animals was similar to that of the controls.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS):
- The mating index were unaffected by the treatment. The pre-coital interval was similar in the control and the treated groups.
- All paired animals (except one pair at 250 and 500 mg/kg/day) mated within 1 to 4 days of cohabitation, i.e. within the duration of a single estrous cycle.
- The fertility index (pregnant/mated) ranged from 83.3% to 100%. The number of pregnant females was comparable within the groups (10/12, 10/12, 12/12, and 10/12 in the control, 250, 500 and 1000 mg/kg bw/day, respectively).
- The duration of gestation was similar in the control and the treated groups, and close to the normal value of 21 to 22 days.
- The gestation index (number of females with live born/number of pregnant female) ranged between 80% and 100%. Although the lowest value (80%) was slightly lower than historical control data (minimum = 90.9%; maximum = 100%), it was recorded in the low dose group only. As the gestation index calculated at 1000 mg/kg bw/day was similar (100%) to controls, the low value recorded in the low dose group was therefore considered to be of fortuitous origin. No difficulty at delivery was observed in any female.
- The number of corpora lutea and implantation sites were similar in the treated groups at all dose-levels. The post-implantation and neo-natal losses were low in the control and the treated groups and within the range of normal values.
ORGAN WEIGHTS (PARENTAL ANIMALS): no treatment related differences in organ weights were observed.
GROSS PATHOLOGY (PARENTAL ANIMALS): no treatment related abnormalities were observed.
HISTOPATHOLOGY (PARENTAL ANIMALS): no treatment related abnormalities were observed.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Results: F1 generation
Details on results (F1)
CLINICAL SIGNS (OFFSPRING): no treatment related clinical signs were observed.
BODY WEIGHT (OFFSPRING): The weights of pups were similar in the control and the treated groups on day 1 and day 4 post-partum.
SEX RATIO (OFFSPRING): The sex ratio was similar in the control and the treated groups, and close to a theoretical value of 50%.
GROSS PATHOLOGY (OFFSPRING): There were no gross external abnormalities in the control or treated groups.
HISTOPATHOLOGY (OFFSPRING): not done
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: no effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Under the conditions of this study, the oral administration of Methanesulfonic Acid, at 250, 500 or 1000 mg/kg bw/day to male and female Sprague-Dawley rats, under the above detailed experimental conditions was well tolerated at all dose-levels. There were no substance-induced effects on the male and female reproductive performance, nor on the progeny of the parental rats up to 1000 mg/kg bw/day. Based on these results, the no observed adverse effect level (NOAEL) for parental toxicity and for toxic effect on reproductive performance and on progeny is 1000 mg/kg bw/day.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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