Assessment in rats of the reproductive toxicity of gasoline from a gasoline vapor recovery unit.
Gasoline (CAS 86290-81-5) is one of the world's largest volume commercial products. Although numerous toxicology studies have been conducted, the potential for reproductive toxicity has not been directly assessed. Accordingly, a two-generation reproductive toxicity study in rats was conducted to provide base data for hazard assessment and risk characterization. The test material, vapor recovery unit gasoline (68514-15-8), is the volatile fraction of formulated gasoline and the material with which humans are most likely to come in contact. The study was of standard design. Exposures were by inhalation at target concentrations of 5000, 10 000, and 20 000 mg/m(3). The highest exposure concentration was approximately 50% of the lower explosive limit and several orders of magnitude above anticipated exposure during refueling. There were no treatment-related clinical or systemic effects in the parental animals, and no microscopic changes other than hyaline droplet nephropathy in the kidneys of the male rats. None of the reproductive parameters were affected, and there were no deleterious effects on offspring survival and growth. The potential for endocrine modulation was also assessed by analysis of sperm count and quality as well as time to onset of developmental landmarks. No toxicologically important differences were found. Therefore, the NOAEL for reproductive toxicity in this study was > or =20 000 mg/m(3). The only systemic effects, in the kidneys of the male rats, were consistent with an alpha-2 u-globulin-mediated process. This is a male rat-specific effect and not relevant to human health risk assessment.
McKee
R H
RH
Exxon Biomedical Sciences, Inc., Annandale, NJ 08801, USA. rhmckee@fpe.erenj.com
Trimmer
G W
GW
Whitman
F T
FT
Nessel
C S
CS
Mackerer
C R
CR
Hagemann
R
R
Priston
R A
RA
Riley
A J
AJ
Cruzan
G
G
Simpson
B J
BJ
Urbanus
J H
JH
D000280:Administration, Inhalation; D000395:Air Pollutants, Occupational / Q000633:toxicity*; D000818:Animals; D000831:Animals, Newborn / Q000254:growth & development; D001273:Atmosphere Exposure Chambers; D001835:Body Weight / Q000187:drug effects; D004971:Estrus / Q000187:drug effects; D005260:Female; D005742:Gasoline / Q000633:toxicity*; D006066:Gonads / Q000187:drug effects / Q000473:pathology; D006128:Growth / Q000187:drug effects; D006801:Humans; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects; D011247:Pregnancy; D011297:Prenatal Exposure Delayed Effects; D051381:Rats; D017207:Rats, Sprague-Dawley; D012137:Respiratory System / Q000187:drug effects / Q000473:pathology; D013094:Spermatozoa / Q000187:drug effects / Q000473:pathology
D000395:Air Pollutants, Occupational; D005742:Gasoline