Registration Dossier

Administrative data

Description of key information

Repeated dose toxicity studies are available for samples of gasoline involving exposure by oral, inhalation and dermal routes. The only consistent systemic finding was male rat nephropathy, mediated by accumulation of alpha 2 micro globulin in the kidney tubules. This finding is specific to the male rat and is not relevant to human health.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
1 402 mg/m³
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
0.038 mg/kg bw/day
Study duration:
chronic
Species:
mouse

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Study duration:
chronic
Species:
mouse

Additional information

Repeated exposure of rats by inhalation to unleaded gasoline and naphtha blending stocks produced minor effects and only at the highest levels tested. Reported changes included body weight effects, organ weight changes, variations in hematologic parameters, and red nasal discharge. The only pathological findings reported were changes in male rat kidneys associated with alpha-2u-globulin-induced renal nephropathy, a male rat specific finding that is not relevant for human health. The NOAEC was 1402 mg/m3, based on a body weight effect at higher exposure concentrations.

In a chronic dermal study in mice, there were no discernible systemic effects, indicating that gasoline has a very low potential for systemic toxicity. The only effect of note was moderate to severe dermal irritation at the application site.

The only oral toxicity study identified involved repeated administration of gasoline to male rats to investigate the potential of gasoline and other light hydrocarbon streams to cause alpha 2 micro globulin mediated nephropathy in rats. A sample of gasoline caused light hydrocarbon nephropathy and the LOEL for this lesion was 500 mg/kg. This finding is specific to the male rat and is not relevant to human health.

Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:

One of 6 studies investigating repeat dose toxicity following inhalation exposure for periods up to 2 yrs. The only consistent effect was alpha 2u nephropathy in male rats, an effect which is not relevant for human health.

Justification for selection of repeated dose toxicity dermal - systemic effects endpoint:

Chronic dermal mouse study. No systemic toxicity or carcinogenic effect reported

Justification for selection of repeated dose toxicity dermal - local effects endpoint:

chronic dermal application study. Skin irritation only at dose 0.05 mL/kg, equivalent to 0.038 mg/kg bw/day.

Justification for classification or non-classification

Many of the studies described in this section followed regulatory guidelines and many have been published in the scientific literature.  The data are sufficient for regulatory purposes, no additional testing is necessary. According to EU CLP regulation (EC No. 1272/2008), the classification for systemic toxicity is not warranted.