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Diss Factsheets

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:
2000
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:
1994
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

Constituent 1
Chemical structure
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
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.