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Effects on fertility

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READ ACROSS DATA: C9-14 aliphatics (<2% aromatic) 

 

C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids (decane) were examined for reproductive toxicity in a 28 day combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD TG 422).  C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were administered oral gavage at a dose of 0, 25, 150, or 1000 mg/kg/day to groups of Sprague-Dawley rats. It was concluded that C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids did not induce reproductive toxicity in the parental animals and no effects on the endocrine system were observed.  Therefore, the NOAEL was determined to be >=1000 mg/kg bw/day. 

 

C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids (undecane) were examined in a reproduction / developmental toxicity screening test (OECD TG 422).  C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were administered by oral gavage at a dose of 0 (vehicle), 100, 300, 1000 mg/kg/day to groups of Sprague-Dawley rats. It was concluded that C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids did not induce reproductive toxicity in the parental animals and no effects on the endocrine system were observed.  Therefore, the NOAEL was determined to be >=1000 mg/kg bw/day. 

 

READ ACROSS DATA: JP-8 Fuel (C9-C16 Aliphatics, 25% Aromatics) 

There were several studies located for the structurally analogous test material, JP-8 fuel. JP-8 fuel was examined for reproductive toxicity in a 70 day male and in a 90 day female one generation reproductive toxicity study (OECD TG 414). For the male reproductive toxicity study, the reproductive NOAEL >= 3000 mg/kg/day for male rats, which was the highest dose tested. For the female reproductive toxicity study, the reproductive NOAEL >= 1500 mg/kg/day for female rats, which was the highest dose tested. The F1 (fetus) NOAEL = 750 mg/kg/day based on a decrease in body weight that correlated to a decrease in maternal body weight.

 

READ ACROSS DATA: C9-14 aliphatics (2-25% aromatic) 

C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids were examined for reproductive toxicity in a reproduction / developmental toxicity screening test (OECD TG 421).  C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids were administered by inhalation at a dose of 0,100, and 300 ppm to groups of rats. It was concluded that C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids did not induce reproductive toxicity in the offspring or in the parental animals.  Therefore, the NOAEL was determined to be >=300 ppm (1720 mg/m3).


Short description of key information:
Reproduction Toxicity
READ ACROSS DATA: C9-14 aliphatics (<2% aromatic)
Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) – Oral Administration (decane) - The NOAEL for developmental toxicity was >=1000 mg/kg/day and the NOAEL for reproductive toxicity was >=1000 mg/kg/day.
Reproduction / Developmental Toxicity Screening Test (OECD TG 422) - Oral Administration (undecane) - The NOAEL for developmental toxicity was >=1000 mg/kg/day and the NOAEL for reproductive toxicity was >=1000 mg/kg/day.
READ ACROSS DATA: JP-8 Fuel (C9-C16 Aliphatics, 25% aromatics)
One-Generation Reproduction Toxicity Study (OECD TG 415) - Male Fertility Test – Oral Administration - 90d prior to mating, the NOAEL >=3000 mg/kg/day, which was the highest dose tested.
READ ACROSS DATA: C9-14 aliphatics (2-25% aromatic)
Reproduction / Developmental Toxicity Screening Test (OECD TG 421) - Inhalation Administration - The NOAEL for developmental toxicity was >=300 ppm (1720 mg/m3).

Effects on developmental toxicity

Description of key information
One developmental study was available on C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

One developmental study was available in rats orally exposed to C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.

Justification for classification or non-classification

These findings do not warrant the classification of C14-C20 aliphatics, <2% aromatic hydrocarbons as teratogenic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances.