Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
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.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
