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EC number: 205-293-0 | CAS number: 137-42-8
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Repeated dose dermal toxicity study of Metam-sodium in Rabbit .
- Author:
- European Commission
- Year:
- 2 000
- Bibliographic source:
- European Commission, European Chemicals Bureau, 2000
- Reference Type:
- secondary source
- Title:
- Repeated dose dermal toxicity study of Metam-sodium in Rabbit
- Author:
- US EPA
- Year:
- 1 994
- Bibliographic source:
- United states environment protection agency, 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxicity for Metam Sodium in White Russians male and female rabbits for 21 days by dermal application.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Metam-sodium
- EC Number:
- 205-293-0
- EC Name:
- Metam-sodium
- Cas Number:
- 137-42-8
- Molecular formula:
- C2H5NS2.Na
- IUPAC Name:
- sodium (methylcarbamothioyl)sulfanide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material : Metam-sodium
- Molecular formula : C2H4NNaS2
- Molecular weight : 129.1826 g/mol
- Smiles notation : C(=S)(NC)[S-].[Na+]
- InChl : 1S/C2H5NS2.Na/c1-3-2(4)5;/h1H3,(H2,3,4,5);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Metam-sodium
- Molecular formula : C2H4NNaS2
- Molecular weight : 129.1826 g/mol
- Smiles notation : C(=S)(NC)[S-].[Na+]
- InChl : 1S/C2H5NS2.Na/c1-3-2(4)5;/h1H3,(H2,3,4,5);/q;+1/p-1
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rabbit
- Strain:
- other: White Russians
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified.
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- other: 0.8% hydroxypropylmethylcellulose
- Details on exposure:
- The test substance was applied to the shaved intact and abraded skin for an exposure time of 8 hours a day in 0.8% hydroxypropylmethylcellulose.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- 0,31.25, 62.5 and 125 mg/kg bw /day
- No. of animals per sex per dose:
- 5 animals/dose level/sex/skin/condition
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Not specified
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified
WATER CONSUMPTION: Not specified
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: At the end of the study.
HAEMATOLOGY: Yes
- Time schedule for collection of blood: performed in all
animals before the first application as well as after the
three test weeks
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: performed in all
animals before the first application as well as after the
three test weeks
URINALYSIS: Yes
- Time schedule for collection of urine: performed in all
animals before the first application as well as after the
three test weeks
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Not specified
HISTOPATHOLOGY: Yes, at the end of the study microscopic examination was performed. - Statistics:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- The lowest dosage (31.25 mg/kg bw/d) was tolerated without any local effects in treated group compare to control.
Middle dose (62.5 mg/kg) caused locally slight to moderate erythema as well as slight edema. After discontinuation of dosing erythema disappeared rapidly,
edema had receded before in treated group.
At high dose 125 mg/kg caused more severe skin injury. Erythema were seen with formation of rhagades. Moderate edema were also observed. After 21 days of application these skin changes were found in all treated animals compare to control. - Dermal irritation:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Mortality:
- no mortality observed
- Description (incidence):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No significant effect were observed at all doses 0,31.25, 62.5 and 125 mg/kg bw in treated group compare to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histology showed slight epidermo–dermatitis in all animals. During the follow–up period, all local effects disappeared within 4–11 days. At 125 mg/kg moderate to marked epiderm–dermatitis was seen in all animals after the period of application but this was reversible within the follow–up period.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 31.25 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed at this dose
- Remarks on result:
- other: No toxic effecty were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 31.25 mg/kg bw/day for Metam Sodium in White Russians male and female rabbits for 21 days by dermal application.
- Executive summary:
Repeated dose dermal toxicity study was assessed for possible toxic potential. For this purpose Subacute assay was performed onWhite Russians male and female rabbits by using a concentration of 0, 31.25, 62.5 and 125 mg/kg bw/day. The test substance was applied to the shaved intact and abraded skin for an exposure time of 8 hours a day in 0.8% hydroxypropylmethylcellulose for 21 days. Skin reactions as well as behaviour and external appearance were observed daily. Body weights were determined once a week. Urinalysis, haematology and clinical chemical investigations were performed in all animals before the first application as well as after the three test weeks. Ophthalmological, gross–pathological and histological examinations were carried out in all animals at the end of the study. The lowest dosage (31.25 mg/kg bw/d) was tolerated without any local effects. 62.5 mg/kg caused locally slight to moderate erythema as well as slight edema.After discontinuation of dosing erythema disappeared rapidly,edema had receded before. 125 mg/kg caused more severe skin injury. Erythema were seen with formation of rhagades. Moderate edema were also observed. After 21 days of application these skin changes were found in all animals. Histology showed slight epidermo–dermatitis in all animals. During the follow–up period, all local effects disappeared within 4–11 days. At 125 mg/kg moderate to marked epiderm–dermatitis was seen in all animals after the period of application but this was reversible within the follow–up period. Therefore NOAEL was considered to be 31.25 mg/kg bw/day for Metam Sodium in White Russians male and female rabbits for 21 days by dermal application.
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