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Effects on fertility

Additional information

Inhalation. The read-across material, C9 Aromatic hydrocarbons, was examined for toxicity in a three-generation reproductive toxicity study. 30 rats of each sex (F0 generation) were exposed via inhalation to 100, 500, or 1500 ppm of high flash aromatic naphtha for 6 hrs/day, 5 days/week for 10 weeks. Rats were then mated, and females confirmed mated were then exposed for 6 hrs/day during gestation days 0 to 20. Dams were not exposed during delivery, but exposure was reinitiated on postnatal day 5 and continued through postnatal day 21 (weaning). This F1 generation was then exposed for 10 weeks starting at 5 to 7 weeks of age, then mated to produce the F2 generation. The F2 generation was treated similarly to the F1 generation, except they were exposed immediately after weaning to produce the F3 generation. Under these conditions, reduced survival and body weight gains were observed in the offspring of the high exposure group. Although this was evidence of a toxic effect at the highest dose tested, there were no reproductive effects. The NOAEL was determined to be >=1500 ppm mg/kg bw/day for males and females. Based on this study, C10-C12 Aromatic Hydrocarbons, are not expected to be reproductive toxicants.

 

Oral. N-butylbenzene, a C10 aromatic hydrocarbon, was examined for toxicity in a two-generation reproductive toxicity study. N-butylbenzene was administered by oral gavage at dose levels of 0, 30, 100, and 300 mg/kg/day to groups of Crj: CD (SD) IGS rats (24 males and 24 females per group) over 2 generations, and the effects on fertility of the parental animals and development/growth of the offspring were investigated. It was concluded that n- butylbenzene did not induce reproductive toxicity in the F1 parental animals and no effects on the endocrine system were observed. Therefore, the NOAEL was determined to be >=300 mg/kg bw/day. Based on this study, C10-C12 Aromatic Hydrocarbons, are not expected to be reproductive toxicants.


Short description of key information:
Inhalation. The read-across material, C9 Aromatic hydrocarbons, was examined for toxicity in a three-generation reproductive toxicity study. The NOAEL was determined to be >=1500 ppm mg/kg bw/day for males and females.

Oral. N-butylbenzene, a C10 aromatic hydrocarbon, was examined for toxicity in a two-generation reproductive toxicity study. NOAEL was determined to be >=300 mg/kg bw/day.

Effects on developmental toxicity

Description of key information
Maternal (oral) NOAEL = 150 mg/kg/day
Developmental (oral) NOAEL is greater than 450 mg/kg/day.
Additional information

C10-C12 Aromatic fluids are not developmental toxicants. In a developmental study, pregnant dams were dosed by oral gavage with 75, 150 or 450 mg/kg/day C10-C12 Aromatic fluids during gestational days 6 through 15. At 450 mg/kg/day, maternal body weight gain and food consumption were significantly decreased during the first three days of treatment. No adverse fetal effects were noted at any dose level. Thus, C10-C12 Aromatic fluids did not produce any fetal toxicity or any developmental effects in rats. Based on the study results, the maternal NOAEL is 150 mg/kg/day and the developmental NOAEL is greater than 450 mg/kg/day.

Justification for classification or non-classification

These findings do not warrant classification of C10-C12 Aromatics 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

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