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Registration Dossier
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EC number: 205-293-0 | CAS number: 137-42-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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 oral Toxicity study of Metam-sodium in Rats by oral gavage
- Author:
- European Commission
- Year:
- 2 000
- Bibliographic source:
- European Commission, European Chemicals Bureau, 2000
- Reference Type:
- secondary source
- Title:
- Repeated dose oral Toxicity study of Metam-sodium in Rats by oral gavage
- 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 of Metam Sodium in male and female rats for subchronic study.
- 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:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Not specified
- Vehicle:
- not specified
- Details on oral exposure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 5 weeks
- Frequency of treatment:
- 3 times per week
Doses / concentrations
- Remarks:
- 0and 0.3 mg/kg bw /day
- No. of animals per sex per dose:
- Total 40 animals
0 mg/kg bw /day – 10 male and 10 females
0.3 mg/kg bw /day- – 10 male and 10 females - 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: Not specified
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
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: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood:
1st examination was conducted after 1 or 3 weeks of treatment.
2nd examination was conducted after 5 weeks of treatment.
3rd examination was conducted 2 weeks after the end of treatment
- How many animals:
1st examination was conducted on 6 animals.
2nd examination was conducted on 10 animals.
3rd examination was conducted on 4 animals.
- Parameters checked in table [No.?] were examined. Hemoglobin concentration and leukocyte counts were determined from blood samples.
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified
OTHER: Organ weight; Liver and kidneys were weighed. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, After treatment for 1 or 3 weeks each 3 animals per sex were sacrificed and animals were examined gross–pathologically. After 5 weeks of treatment 10 animals per sex were sacrificed. The remaining 4 male and female animals were sacrificed 2 weeks after the end of treatment and examined gross–pathologically.
.
HISTOPATHOLOGY: Yes , Various organs from each male and
Female animals were examined. - Other examinations:
- Not specified
- Statistics:
- Not specified
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Two male animals died during the study.
- 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):
- Leucocyte count and methemoglobin levels were not alltered at any time point in treated group compare 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:
- no effects observed
- Description (incidence and severity):
- At the end of the treatment, relative liver and kidney weights were increased. These effects were reversible within the Post exposure period.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No pathological findings were observed in the animals sacrificed after 1 or 3 weeks of treatment in treated group compare to control.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In the forestomach of animals which were sacrificed at the end of the treatment period, scar formation and hyperlasia of the mucosa was observed. The other organs were without any findings in treated group compare to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Description (incidence and severity):
- not specified
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 0.3 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 effect 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:
- NOEL was considered to be 0.3 mg/kg bw /day for Metam Sodium in male and female rats for sub chronic study by oral gavage.
- Executive summary:
Repeated dose oral toxicity study ofMetam Sodiumwas assessed for its possible toxic potential. For this purpose a subchronic study was conducted in male and female rats by using test substance at the concentration of 0and0.3mg/kg bw . The test substance was administrated 3 times per week for 5 weeks by oral gavage. Animals were observed for mortality, clinical sign, hematology, organ weight, gross and histopathology. Two male animals died during the study. At the end of the treatment, relative liver and kidney weights were increased. These effects were reversible within the post exposure period. Leucocyte count and methemoglobin levels were not alltered at any timepoint. No pathological findings were observed in the animals sacrificed after 1 or 3 weeks of treatment. In the forestomach of animals which were sacrificed at the end of the treatment period, scar formation and hyperlasia of the mucosa was observed. The other organs were without any findings. As no significant effect were observed at0.3mg/kg. Therefore NOEL was considered to be 0.3 mg/kg bw /day forMetam Sodium in male and female rats for sub chronic study by oral gavage.
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