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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Reprroductive Toxicity study of Metam-sodium in Rats
- Author:
- European Commission
- Year:
- 2 000
- Bibliographic source:
- European Commission, European Chemicals Bureau, 2000
- Reference Type:
- review article or handbook
- Title:
- Multigeneration reproduction study of Metam-sodium in Rats
- Author:
- Linda L. Carlock
- Year:
- 2 001
- Bibliographic source:
- Handbook of Pesticide Toxicology, Chapter 87, Volume 2.2001. Toxicology and Regulatory Consulting, , UCB Chemicals Corporation
- Reference Type:
- secondary source
- Title:
- Metam-sodium: 2-Generation reproductive toxicity study in rats
- 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 below
- Principles of method if other than guideline:
- Multigeneration reproduction study of Metam-sodium in Rats
- 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
- Details on test material:
- SMILES:CNC(=S)S{-}.[Na]{+}
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Metam-sodium
- Molecular formula (if other than submission substance): C2H4NNaS2
- Molecular weight (if other than submission substance): 129.1826 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- other: Alpk: Apf SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Barriered animal breeding unit at Zeneca Pharmaceuticals, Alderley Park, Macclesfield, Cheshire, UK
- Age at study initiation: (P) x wks; (F1) x wks: 10 weeks
Administration / exposure
- Route of administration:
- oral: drinking water
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Remarks:
- drinking
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): drinking water
- Concentration in vehicle: 0, 1.2, 3.2 and 11.5 mg/kg/day for males and 0, 1.8, 3.9 and 13.5 mg/kg/day for females. - Details on mating procedure:
- Details on study schedule
- F1 parental animals not mated until [...] weeks after selected from the F1 litters.
- Selection of parents from F1 generation when pups were [...] days of age.
- Age at mating of the mated animals in the study: [...] weeks
(Explain how study was performed on perents and offspring separately whatever information we have) At 21 days of age, pups from the parental (F0) generation
were selected as parents for the F1 generation.
- M/F ratio per cage: 1:1 - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 65 days and more
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 1.2 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 3.2 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 11.5 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 1.8 mg/kg bw/day
- Remarks:
- for female
- Dose / conc.:
- 3.9 mg/kg bw/day
- Remarks:
- for female
- Dose / conc.:
- 13.5 mg/kg bw/day
- Remarks:
- for female
- No. of animals per sex per dose:
- Total: 240
0 (vehicle) mg/kg/day: 30 male, 30 female
1.2 mg/kg/day: 30 male
3.2 mg/kg/day: 30 male
11.5 mg/kg/day: 30 male
1.8 mg/kg/day: 30 female
3.9 mg/kg/day: 30 female
13.5 mg/kg/day: 30 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, Clinical sign, Body weight and weight gain, food consumption and water consumption were examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Clinical sign and Body weights sex were examined.
- Postmortem examinations (parental animals):
- Gross pathology and histopathology was examined
- Postmortem examinations (offspring):
- Gross pathology and histopathology was examined
- Statistics:
- Not specified
- Reproductive indices:
- Not specified
- Offspring viability indices:
- Not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival of treated male and female rats were observed.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 11.5 mg/kg/day for male and 13.5 mg/kg/day for female, Decreased in body weight was observed in treated male and female rats as compared to control.
When treated wtih 30 mg/kg bw, slight Decreased in body weight was observed. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 11.5 mg/kg/day for male and 13.5 mg/kg/day for female, Decreased in food consumption was observed in treated male and female rats
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 11.5 mg/kg/day for male and 13.5 mg/kg/day for female, Decreased in water consumption was observed in treated male and female rats
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in the epithelium of
nasal passages in adult females were observed at 13.5 mg/kg/day.
Systemic toxicity consisted of (1) duct hypertrophy of Bowman's gland with loss of alveolar cells,
(2) degeneration, disorganization, and/or
atrophy of the olfactory epithelium, and
(3) dilation of the Bowman's gland ducts. Changes in Bowman's glands were accompanied in all affected animals by degeneration, disorganization, and/or atrophy of the olfactory epithelium.
No effect were observed in male rats. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect on Reproductive performance was observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- gross pathology
- reproductive performance
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (P0)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in F1 mean pup weight on Day 22 were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 11.5 mg/kg/day for male and 13.5 mg/kg/day female, marginal decreased in food consumption was observed in treated male and female rats
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effect on Reproductive performance was observed in treated F1 pups as compared to control.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 11.5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on reproduction
- Remarks on result:
- other: No effect observed
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 13.5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on reproduction
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F1)
- 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
Results: F2 generation
General toxicity (F2)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Decrease in mean body weight gain for F2 litters was observed.
- 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:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 11.5 mg/kg/day for male, decreases 8-9% in testes and epididymis weight in male pups in the F1a and F2a litters.
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F2)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F2)
- Developmental immunotoxicity:
- not specified
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 3.2 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effect observed
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 3.9 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effect observed
Target system / organ toxicity (F2)
- 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
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 11.5 mg/kg/day for male and 13.5 mg/kg/day female for P and F1 generation when Alpk: Apf SD male and female rats were treated with Metam-sodium orally by gavage for 65 days and more days.
- Executive summary:
In a Reproduction Toxicity Test, Alpk: Apf SD male and female rats were treated with Metam-sodiumin the concentration of 0,11.5 mg/kg/day for male and13.5 mg/kg/day female orally in drinking water for 65 days and more days.No effect on survival of treated male and female rats were observed.Decreased in body weight was observed at11.5 mg/kg/day for male and13.5 mg/kg/day female rats as compared to control.Slight Decreased in body weight was observed at 3.2 mg/kg bw in male and 3.9 mg/kg bw mg/kg bw in female. Decreased in food consumption and water consumption was observed at11.5 mg/kg/day for male and13.5 mg/kg/day female rats.Red spot on pituitary gland, Twisted snout was observed at11.5 mg/kg/day for male and13.5 mg/kg/day female. However relation to treatment was doubtful.Changes in the epithelium of nasal passages in adult females were observed at13.5 mg/kg/day. Systemic toxicity consisted of (1) duct hypertrophy of Bowman's gland with loss of alveolar cells,(2) degeneration, disorganization, and/oratrophy of the olfactory epithelium, and (3) dilation of the Bowman's gland ducts. Changes in Bowman's glands were accompanied in all affected animals by degeneration, disorganization, and/or atrophy of the olfactory epithelium.No effect were observed in male rats. Similarly, Decrease in F1 mean pup weight on Day 22 and marginal decreased in food consumption were observed at 11.5 mg/kg/day for male and13.5 mg/kg/day female as compared to control.Decrease in mean body weight gain for F2 litters was observed.Decreases 8-9% in testes and epididymis weight in male pups in the F1a and F2a litters at11.5 mg/kg/day in male rats were observed. In addition,No effect onReproductive performancewas observed in treated P and F1 rats as compared to control.Therefore, NOAEL was considered to be 11.5mg/kg/day for male and 13.5 mg/kg/day female for P and F1 generation when Alpk: Apf SD male and female rats were treated with Metam-sodium orally by gavage for in drinking water for 65 days and more days.
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