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EC number: 200-625-0 | CAS number: 66-27-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer- reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Differential susceptibility of rat embryos to Methyl Methansulfonateduring the pregastrulation period
- Author:
- Ryohei Yokoi, Satoshi Suda, Kazuo Kobayashi, Junji Kuroda, Hiroshi Kusama, Hiroshi Kagami and Tamao Ono
- Year:
- 2 007
- Bibliographic source:
- The Journal of Toxicologcal Sciences, Vol 32, No.5 495-503,2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Embryonic and placental development toxicityy study of Methyl Methansulfonate (MMS) in rat
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Methyl methanesulphonate
- EC Number:
- 200-625-0
- EC Name:
- Methyl methanesulphonate
- Cas Number:
- 66-27-3
- Molecular formula:
- C2H6O3S
- IUPAC Name:
- methyl methanesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Methyl Methansulfonate (MMS)
- Molecular formula (if other than submission substance): C2H6O3S
- Molecular weight (if other than submission substance): 110.1324 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 00.1 %
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Methyl Methansulfonate (MMS)
- Molecular formula (if other than submission substance): C2H6O3S
- Molecular weight (if other than submission substance): 110.1324 g/mole
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 00.1 %
Test animals
- Species:
- rat
- Strain:
- other: Crj:CD (SD)IGS (SD)
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Japan (Shiga, Japan)
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Animals were housed individually in a stainless steel mesh cages (260by 230 by 180 mm) with barrier facility
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: Yes, period not mention.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2˚C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 hr light / 12 hr dark cycle (light from 0800 to 2000 hr)
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Remarks:
- distilled
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Methyl Methansulfonate (MMS) was dissolved in distilled water and prepared freshly daily.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Distilled water
- Concentration in vehicle:0 and 200 mg/kg/bw/day
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - M/F ratio per cage: 1:1 ratio
- Length of cohabitation: Overnight
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy Presence of a vaginal plug or of sperm in the vaginal smear on the morning after mating is referred as day 0 of gestation.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data available
- After successful mating each pregnant female was caged (how): No data available
- Any other deviations from standard protocol: No data available - Duration of treatment / exposure:
- 7 days
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 68
0 mg/kg body weight /day: 8 female
200 mg/kg body weight /day: GD0 :9 female
200 mg/kg body weight /day: GD1 :8 female
200 mg/kg body weight /day: GD2 :9 female
200 mg/kg body weight /day: GD3 :8 female
200 mg/kg body weight /day: GD4 :8 female
200 mg/kg body weight /day: GD5 :9 female
200 mg/kg body weight /day: GD6 :9 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
Examinations
- Maternal examinations:
- Erythrocyte parameters, Number of pregnant female, Pre-implantation and post implantation loss, Intrathoracic and intraperitoneal organs and Gross abnormalities were examined.
- Ovaries and uterine content:
- Number of live fetuses, Number of implantation sites and number of corpora lutea was examined.
- Fetal examinations:
- Number of live and deid fetuses, fetal body weigth, placental weight, External malformation in live fetuses, frequency of visceral malformations and variations in live feuses, frequency of skeletal malormation and progress of ossification in live fetuses were examined.
- Statistics:
- Statisical analysis were done by using Mann-Whitney rank sum test with the Yates corection for ties to compare the number of corpora lutea, the number of implatations, the number of live fetuses, fetal weight, placental weight, hematologic parameters, indices of postimplantation or variations. The chi-square test was useed to analyze the pregnancy rate. Data are presented as mean ± S.D. unless indicated otherwise. A p value of < 0.05 was considered statistically significant.
- Indices:
- Fertility index, gestation index, implantation index, Pre and post embryonic viability indices were observed.
- Historical control data:
- not specified
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Erythrocyte parameters:
No significant change were observed in treated rat as compared to control. - Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- In GD6, significant decrease in placental weight was observed.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Description (incidence and severity):
- In GD0, significant increase in preimplantation loss were observed.
In GD0, GD3, GD4 and GD6, significant increase in postimplantation loss were observed as compared to control. - Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant difference were observed in fetal mortality data for GD3 to GD6 as compare to control.
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- not specified
- Other effects:
- not specified
Effect levels (maternal animals)
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- dead fetuses
- early or late resorptions
- organ weights and organ / body weight ratios
- pre and post implantation loss
- Remarks on result:
- other: Effect on reproductive performance
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
Results (fetuses)
- Fetal body weight changes:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): effects observed, treatment-related
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Significant decreased in fetal weight were observed for male and female in GD5 and GD6 - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- In GD6, malformation in litters and fetus were observed as compared to control.
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- In GD1 and GD2, fetus with misshapen thoracic centrum and fused ribs were observed.
In GD5, ossified sacral/caudal vertebrae were observed as compare to control. - Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- In GD5 and GD6, variations consisted of thymic remnant in the neck, persistent left unbilival artery, variation of lobation of lung; dilated ureter and dislated renal pelvis were observed as compared to control.
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
- Remarks on result:
- other: Effect observed
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Lowest-observed-adverse-effect level (LOAEL) for P and F1 generation was considered to be 200 mg/kg/bw/day when Crj:CD (SD)IGS (SD) female rat were treated with Methyl Methansulfonate by orally by gavage for 7 days.
- Executive summary:
In a developmental toxicity study, femaleCrj:CD (SD)IGS (SD)rat were treated with Methyl Methansulfonate in the concentration of 0 and 200 mg/kg/bw/day. Results show that Methyl Methansulfonate was toxic. Toxic effect was observed as reduction inNumber of live fetuses, placental weight and increased preimplantation loss and postimplantation loss in treated rat as compared to control. In addition gross pathological changes such as malformation of litters and fetus, external malformations in live fetuses and ossified sacral/caudal vertebrae were observed. Therefore,lowest-observed-adverse-effect level (LOAEL) for P and F1 generation was considered to be 200 mg/kg/bw/day when Crj:CD (SD)IGS (SD) female rat were treated with Methyl Methansulfonate by orally by gavage for 7 days.
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