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Learn More About LACTROL® - LACTROL® MSDS
LACTROL® MSDS - Page 3 of 3
SECTION 11 - TOXICOLOGY INFORMATION
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| Toxicology summary |
The information included in this section describes the
potential hazards of the active ingredient |
| Acute toxicity |
| Compound |
Type |
Route |
Species |
Dosage |
| Virginiamycin |
LD50 |
Oral |
Dog |
> 4,000 mg/kg |
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LD50 |
Oral |
Mouse |
> 5,000 mg/kg |
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LD50 |
Oral |
Rat |
10,000 mg/kg |
|
| Eye |
No data available |
| Skin |
No data available |
| Inhalation |
No data available |
| Ingestion |
See table above |
| Mutagenicity |
Virginiamycin was not mutagenic in microbial cells, but
was weakly positive in in vitromammalian cells.
Overall, it is unlikely to be a true genotoxin. |
| Subchronic effects |
Virginiamycin was evaluated in rats for three months
and in dogs for 3 to six months at doses up
to 100mg/kg/day. No significant drug-related
effects were seen at any dose level in either
species. In a six month study of dogs at higher
dose levels the NOEL was established at 200 mg/kg/day. |
| Chronic effects / carcinogenicity |
In a long-term oral toxicity study mice were fed doses
up to 100 mg/kg/day and no drug related effects
were observed. The NOEL for toxicity and carcinogenicity
in this study were determined to be 1000 mg/kg/day.
In a long-term oral toxicity study rats were
fed doses up to 300 mg/kg/day. At dose levels
greater than 50 mg/kg/day reduced body weight
and increased food consumption was noted. Some
changes in clinical chemistry parameters were
observed in males, but not females. The toxicity
NOEL for this study was established at 50 mg/kg/day
and the carcinogenicity for this study was
determined to be 300 mg/kg/day. |
| Carcinogen status |
Not listed as a carcinogen by IARC, NTP or US OSHA. |
| Reproductive effects |
In a two-generation study in rats, no treatment-related
reproductive effects were observed at doses
up to 100 mg/kg/day. |
| Teratogenicity |
No treatment-related teratogenic effects were observed
in rats or mice at doses up to 200 or 1000
mg/kg/day, respectively. |
| At increased risk from exposure |
Individuals with a known history of hypersensitivity
to this material or other materials in its
chemical class may be more susceptible to toxicity in cases of overexposure. |
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SECTION 12 - ECOLOGICAL INFORMATION
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| Environmental overview |
n the environment, this substance can be expected to
bind to soil and sediment and degrade rapidly.
No harmful effects to aquatic organisms are
expected. |
| Mobility, persistence, and degradability |
This substance binds to soil and sediment, degrades rapidly,
and does not persist. |
| Bioaccumulation & toxicity |
Low acute toxicity to aquatic organisms is expected.
This material has low potential to bioaccumulate
(based on animal data) and long-term adverse
effects to aquatic organisms are not expected. |
| Log P |
(octanol/water partition coefficient) >7.35@25°C,
pH 7 (virginiamycin) |
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SECTION 13 - DISPOSAL INFORMATION
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| Disposal procedure |
Incineration is the recommended method of disposal for
this material. Observe all local and national
regulations when disposing of this material. |
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SECTION 14 - TRANSPORTATION INFORMATION
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| General shipping instructions |
Not regulated |
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SECTION 15 - REGULATORY INFORMATION
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| TSCA status |
Not listed |
| SARA section 302 |
No |
| SARA section 313 |
No |
| California Proposition 65 |
Not listed |
| Canadian WHMIS |
This product has been classified in accordance with the
hazard criteria of the CPR and the MSDS contains
all of the information required by the CPR. |
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SECTION 15 - OTHER
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| Disclaimer |
Phibro Animal Health believes that the information contained
in this Material Safety Data Sheet is accurate,
and while it is provided in good faith, it
is without a warranty of any kind, expressed
or implied. |
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