Technical Specifications

PROVA-SEAL PBS10FLOZCDN - WHITE EFFECTIVE DATE: MARCH 3, 2015
PAGE 6 OF 10
11. TOXICOLOGICAL INFORMATION (Continued)
TOXICITY DATA (continued):
PROPYLENE GLYCOL (continued):
LD
50
(Oral-Quail) > 2080 mg/kg
LD
50
(Skin-Rabbit) 20,800 mg/kg
LD
50
(Skin-Rabbit) 20,800 mg/kg: Behavioral: ataxia, tetany; Lungs, Thorax, or
Respiration: respiratory depression
LD
50
(Intraperitoneal-Rat) 6660 mg/kg
LD
50
(Intraperitoneal-Mouse) 9718 mg/kg: Lungs, Thorax, or Respiration: chronic
pulmonary edema; Kidney/Ureter/Bladder: changes in both tubules and glomeruli;
Blood: changes in spleen
LD
50
(Intraperitoneal-Mouse) 11,400 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax,
or Respiration: respiratory depression
LD
50
(Subcutaneous-Rat) 22,500 mg/kg
LD
50
(Subcutaneous-Rat) 28,000 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LD
50
(Subcutaneous-Mouse) 17,370 mg/kg: Behavioral: changes in motor activity
(specific assay), muscle contraction or spasticity; Lungs, Thorax, or Respiration:
cyanosis
LD
50
(Subcutaneous-Mouse) 17,400 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax,
or Respiration: respiratory depression
LD
50
(Intravenous-Rat) 6800 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LD
50
(Intravenous-Rat) 6423 mg/kg
LD
50
(Intravenous-Mouse) 8000 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LD
50
(Intravenous-Mouse) 6630 mg/kg
LD
50
(Intravenous-Dog) 26 gm/kg
LD
50
(Intravenous-Rabbit) 6500 mg/kg
LD
50
(Intramuscular-Rat) 14 gm/kg
LD
50
(Intramuscular-Rat) 20,000 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LDLo (Oral-Rabbit) 20,000 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LDLo (Intramuscular-Rabbit) 6300 mg/kg: Behavioral: somnolence (general depressed
activity), coma; Lungs, Thorax, or Respiration: respiratory stimulation
LDLo (Subcutaneous-Guinea Pig) 15,500 mg/kg
LDLo (Subcutaneous-Guinea Pig) 15,500 mg/kg: Behavioral: ataxia, tetany Lungs,
Thorax, or Respiration: respiratory depression
LDLo (Intravenous-Chicken) 27 gm/kg: Vascular: other changes
LDLo (Intravenous-Rabbit) 4200 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
LDLo (Intramuscular-Mouse) 6300 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
TDLo (Oral-Rat) 88,269 mg/kg/30 days-intermittent: Endocrine: hyperglycemia
Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels:
phosphatases, transaminases
PROPYLENE GLYCOL (continued):
TDLo (Oral-Rat) 84 mL/kg/30 days-continuous: Blood: changes in serum composition
(e.g. TP, bilirubin, cholesterol) Blood: changes in leukocyte (WBC) count;
Biochemical: Enzyme inhibition, induction, or change in blood or tissue levels:
multiple enzyme effects
TDLo (Oral-Dog) 3650 mg/kg/2 years-intermittent: Blood: normocytic anemia, other
hemolysis with or without anemia
TDLo (Skin-Mouse) 1,284,800 mg/kg/2 years-intermittent: Skin and Appendages:
tumors
TDLo (Intraperitoneal-Rat) 19,500 mg/kg: Behavioral: ataxia, tetany Lungs, Thorax, or
Respiration: respiratory depression
TDLo (Intraperitoneal-Mouse) 100 mg/kg: female 11 day(s) after conception:
Reproductive: Fertility: post-implantation mortality (e.g. dead and/or resorbed
implants per total number of implants)
TDLo (Intraperitoneal-Mouse) 100 mg/kg: female 15 day(s) after conception:
Reproductive: Effects on Embryo or Fetus: fetotoxicity (except death, e.g., stunted
fetus)
TCLo (Inhalation-Rat) 2180 mg/m
3
/6 hours/90 days-intermittent: Behavioral: food intake
(animal); Endocrine: changes in spleen weight; Biochemical: Enzyme inhibition,
induction, or change in blood or tissue levels: dehydrogenases
DNA Inhibition (Subcutaneous-Mouse) 8000 mg/kg
Cytogenetic Analysis (Subcutaneous-Mouse) 8000 mg/kg
Cytogenetic Analysis (Hamster Fibroblast) 32 gm/L
TITANIUM DIOXIDE:
Standard Draize Test (Skin-Human) 300 µg/3 days-intermittent: Mild
TC (Inhalation-Rat) 10 mg/m
3
/18 hours/2 years-intermittent: Tumorigenic: carcinogenic
by RTECS criteria; Lungs, Thorax, or Respiration: tumors
TCLo (Inhalation-Rat) 250 mg/m
3
/6 hours/2 years-intermittent: Tumorigenic:
carcinogenic by RTECS criteria; Lungs, Thorax, or Respiration: tumors
TD (Intramuscular-Rat) 260 mg/kg/84 weeks-intermittent: Tumorigenic: equivocal
tumorigenic agent by RTECS criteria; Blood: lymphoma, including Hodgkin's disease;
Tumorigenic: tumors at site of application
TDLo (Intratracheal-Mouse) 100 mg/kg: Tumorigenic: increased incidence of tumors in
susceptible strains
TDLo (Intramuscular-Rat) 360 mg/kg/2 years-intermittent: Tumorigenic: neoplastic by
RTECS criteria; Blood: lymphoma, including Hodgkin's disease; Tumorigenic: tumors
at site of application
DNA Damage (Human Lung) 100 µg/plate
DNA Damage (Human Lung) 20 µg/disk/4 hours
Sister Chromatid Exchange (Human Lymphocyte) 2 µmol/L/72 hours
Micronucleus Test (Human Lymphocyte) 5 µmol/L/72 hours
Micronucleus Test (Intraperitoneal-Mouse) 3 gm/kg/3 days-continuous
Micronucleus Test (Hamster Ovary) 5 µmol/L
DNA Inhibition (Hamster Lung) 500 mg/L
Sister Chromatid Exchange (Hamster Ovary) 1 µmol/L
IRRITANCY OF PRODUCT: Inhalation of fumes if product if heated or if applied in confined space may cause respiratory
irritation. Eye contact may cause irritation. Prolonged skin contact may cause irritation.
SENSITIZATION OF PRODUCT: This product contains trace amounts of Formaldehyde, which is known to cause skin
sensitization. Persons susceptible or already sensitized to Formaldehyde may experience an allergic reaction.
CARCINOGENIC POTENTIAL OF COMPONENTS: Components of this product are listed by agencies tracking the
carcinogenic potential of chemical compounds, as follows:
QUARTZ SILICA: ACGIH-TLV-A2 (Suspected Human Carcinogen); IARC-1 (Carcinogenic to Humans); MAK-1 (Substances that Cause Cancer in Man and Can Be Assumed
to Make a Significant Contribution to Cancer Risk); NIOSH-Ca (Potential Occupational Carcinogen with No Further Categorization); NTP-K (Known to Be a Human
Carcinogen)
TITANIUM DIOXIDE: ACGIH TLV-A3 (Confirmed Animal Carcinogen); IARC-3 (Unclassifiable as to Carcinogenicity in Humans); NIOSH-Ca (Potential Occupational
Carcinogen, with No Further Categorization)
The remaining components are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S. NIOSH,
GERMAN MAK, IARC, or ACGIH and therefore is neither considered to be nor suspected to be a cancer-causing
agent by these agencies.
REPRODUCTIVE TOXICITY INFORMATION: This product has not been tested for reported mutagenic, embryotoxic,
teratogenic or reproductive toxicity. The following information is available for the Diisononyl Phthalate component:
Embryotoxicity/Teratogenicity: Exposure to phthalates has been reported to result in increased incidence of developmental
abnormalities such as cleft palate and skeletal malformations, and increased fetal death in experimental animal studies. The most
sensitive system is the immature male reproductive tract, with phthalate exposure resulting in increased incidence of
undescended testes, decreased testes weight, decreased anogenital distance (distance between the anus and the base of the
penis), and other effects.
Reproductive Toxicity: Phthalates are classified as endocrine disruptors or hormonally-active agents (HAAs) because of their ability
to interfere with the endocrine system in the body.
ACGIH BIOLOGICAL EXPOSURE INDICES (BEIs): Currently, there are no ACGIH Biological Exposure Indices (BEIs)
determined for this material.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
MOBILITY: This product has not been tested for mobility in soil.
PERSISTENCE AND BIODEGRADABILITY: This product has not been tested for persistence or biodegradability.
BIO-ACCUMULATION POTENTIAL: This product has not been tested for bio-accumulation potential.
ECOTOXICITY: This product has not been tested for aquatic or animal toxicity. All releases to terrestrial, atmospheric and
aquatic environments should be avoided.
OTHER ADVERSE EFFECTS: This material is not listed as having ozone depletion potential.