Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
20 000 mg/m³
Study duration:
chronic
Species:
rat
Quality of whole database:
supporte by 3 screenig studies with low boiling point naphthas
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The toxicology studies in animals revealed no effects of gasoline on reproductive system development or function at levels>20,000 mg/m3, the highest levels tested. Similarly, reproductive toxicity screening tests of several naphtha blending stocks were also without effect at levels>25000 mg/m3, the highest levels tested.  The data do not provide a basis for classification, and there is no need for additional reproductive toxicity studies to be conducted. When there was evidence of systemic toxicity as evidenced by reduced weight gain and/or specific organ effects, these tended to be in the range of 20,000 mg/m3with overall no effect levels being>10,000 mg/m3. Thus these data are very consistent with the results of subchronic toxicity studies reported previously.

Short description of key information:

Reproductive toxicity - NOAEL > 24700 mg/m3 for rat (OECD TG 421)

Justification for selection of Effect on fertility via inhalation route:

well conducted 2-generation study by inhalation

Effects on developmental toxicity

Description of key information

Developmental toxicity - maternal and developmental NOAEL = 23900 mg/m3 (OECD TG 414)

Developmental toxicity - reproductive/developmental NOAEL > 20,000 mg/m3 (half the lower explosive limit) (OECD TG 416)

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
23 900 mg/m³
Study duration:
subchronic
Species:
rat
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
500 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Additional information

Several developmental toxicity studies of gasoline have been carried out in the rat, and two recent studies were consistent with the most current regulatory guidelines. These studies provided little evidence of developmental toxicity; more specifically, the frequency of malformation was not increased, and there was no evidence of fetal toxicity or lethality. The overall no adverse effect levels in these studies were 20000 – 24000 mg/m3, the highest levels tested. Studies with naphtha blending stocks provided similar data. These studies were conducted in accordance with current regulatory protocols, and the data can be used without restriction. No additional testing is necessary. The data do not provide a basis for classification for developmental toxicity.

Justification for selection of Effect on developmental toxicity: via inhalation route:

one of four well conducted studies with low boiling point naphthas

Justification for selection of Effect on developmental toxicity: via dermal route:

one of four well conducted studies

Justification for classification or non-classification

The studies followed regulatory protocols and were in accordance with good laboratory practice guidelines. Thus the data can be used without restrictions for regulatory purposes. The data do not provide a basis for classification, and there is no need for additional reproductive toxicity studies to be conducted.

It should be noted that, although the data do not support classification of gasoline per se for reproductive toxicity potential according to EU CLP Regulation (EC No. 1272/2008), there is a regulatory requirement to classify as reprotoxic gasoline and naphtha streams containing >3% toluene and/or n-hexane.