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Effects on fertility

Description of key information

Reproductive Toxicity

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) – Oral Administration - 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 421) - Oral Administration - 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 NOAEC for developmental toxicity was >=300 ppm (1720 mg/m3).

Additional information

C9-C14 aliphatic, <2% aromatic hydrocarbon fluids 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 were examined in a reproduction / developmental toxicity screening test (OECD TG 421).  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. 

 

Based on this study and the lack of systemic toxicity, C9-C14 aliphatic, <2% aromatic hydrocarbon fluids, are not expected to be reproductive toxicants.

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 NOAEC was determined to be >=300 ppm (1720 mg/m3).

Effects on developmental toxicity

Description of key information

Developmental Toxicity

Prenatal Developmental Toxicity Study (OECD TG 414) - Inhalation Administration - The maternal and developmental NOAELs were greater than 900 ppm.

Prenatal Developmental Toxicity Study (OECD TG 414) - Inhalation Administration - The maternal and developmental NOAELs were greater than 900 ppm.

Additional information

C9-C14 aliphatic, <2% aromatic hydrocarbon fluids are not developmental toxicants. In two developmental studies (OECD TG 414), pregnant dams were dosed by inhalation with 0, 300, or 900 ppm C9-C14 aliphatic, <2% aromatic hydrocarbon fluids during gestational days 6 through 15.  No adverse maternal or fetal effects were noted at any dose level. Thus, C9-C14 aliphatic, <2% aromatic hydrocarbon fluids did not produce any maternal or fetal toxicity or any developmental effects in rats. Based on the study results, the maternal and developmental toxicity NOAEC is >= 900 ppm (5220 mg/m3). Based on this study and the lack of systemic toxicity, C9-C14 aliphatic, <2% aromatic hydrocarbon fluids, are not expected to be developmental toxicants.

 

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. In a developmental study (OECD TG 414), pregnant dams were dosed by oral gavage with 0, 500, 1000, 1500, or 2000 mg/kg of JP-8 during gestational days 6 through 15. 

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. No adverse maternal or fetal effects were noted at any dose level. 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 NOAEC was determined to be >=300 ppm (1720 mg/m3).

Justification for classification or non-classification

These findings do not warrant classification of C9-C14 aliphatic, <2% aromatic hydrocarbon fluids as a reproductive or developmental toxin under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.