Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

NAFENOPIN

NFPA

PRODUCT USE

Lipid regulating agent. Study in the USA of nafenopin as a hypolipidaemic agent ceased
following reports of liver nodules in rats.

SYNONYMS

C20-H22-O3, "propionic acid, 2-methyl-2-[p-(1, 2, 3, 4-tetrahydro-1-naphthyl)phenoxy]-",
"propionic acid, 2-methyl-2-[p-(1, 2, 3, 4-tetrahydro-1-naphthyl)phenoxy]-", "2-methyl-2-
[4-(1, 2, 3, 4-tetrahydro-1-naphthalenyl)phenoxy]propanoic acid", "2-methyl-2-[4-(1, 2, 3,
4-tetrahydro-1-naphthalenyl)phenoxy]propanoic acid", "alpha-methyl-alpha-(p-1, 2, 3, 4-
tetrahydronaphth-1-ylphenoxy)propionic acid", "alpha-methyl-alpha-(p-1, 2, 3, 4-
tetrahydronaphth-1-ylphenoxy)propionic acid", "2-methyl-2-[p-(1, 2, 3, 4-tetrahydro-1-
naphthyl)phenoxy]propionic acid", "2-methyl-2-[p-(1, 2, 3, 4-tetrahydro-1-
naphthyl)phenoxy]propionic acid", "2-methyl-2-[4-(1, 2, 3, 4-tetrahydro-1-
naphthyl)phenoxy)propanoic acid", "2-methyl-2-[4-(1, 2, 3, 4-tetrahydro-1-
naphthyl)phenoxy)propanoic acid", "nafenoic acid", "CH 13-437", "CH 13-437", "Ciba 13437-
SU", Melipan, SU-13437, TPIA, "hypolipidaemic agent"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Harmful if swallowed.
Limited evidence of a carcinogenic effect.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual.  Accidental ingestion of the material may be damaging to the health of the individual.  Considered an unlikely route of entry in commercial/industrial environments.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  

INHALED

  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  There has been concern that this material can cause cancer or mutations, but there is not enough data to make an assessment.  There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.  

  Principal routes of exposure are usually by skin contact/absorption and inhalation of generated dust.  Prolonged administration of nafenopin to rats and mice induced  hepatocellular carcinomas and produced peroxisome proliferation and  hepatomegaly. The carcinogenicity of peroxisome proliferators appears to  be due to factors other than a direct effect on DNA.  Reddy, J.K. and M.S. Rao, Mutation Research, 214, 63-68, 1989  The material is a non-genotoxic carcinogen which uncouples oxidative  phosphorylation in mitochondria in-vivo.  Chronic administration in rats and hamsters produced a sustained  increase in liver weights and the induction of hepatic peroxisome  proliferation. During the first week of feeding trials hepatic DNA  synthesis was induced in rats and this induction proceeded over the course  of the study (up to 60 weeks). The material also produced liver nodules,  adenomas and carcinomas within 60 weeks in rats. THese effects were not  reproduced in hamsters. The authors of the study (1) noted that the  hamster is a more resistant species to peroxisome proliferator induced  hepatocarcinogenicity. Palmitoyl-CoA oxidation was induced in both rats  and hamsters.  (1) Lake, B.G. et al;  Environmental Health Perspectives, 101, 99 241-248, 1993