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Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No reproductive or developmental toxicity studies have been conducted on the butylene oligomers in this category.  However, reproductive/developmental toxicity screening studies have been conducted on other higher olefins in the range of C8 to C18. In the oral gavage studies, no reproductive or developmental toxicity was observed at doses up to 1,000 mg/kg-day. Neither was there any reproductive or developmental toxicity observed in rats exposed up to 15,000 mg/m3 (the highest exposure concentration tested).

In an OECD TG 421 study, no reproductive or developmental toxicity was observed in the offspring of rats dosed by oral gavage with 100, 300 or 1000 mg/kg 2,4,4-trimethylpentene (HLS, 1997 c). The NOAEL for this study is 1000 mg/kg-day. There was no reproductive or developmental toxicity in a OECD TG 422 study in which rats were dosed by oral gavage with 1 -tetradecene (CAS 1120 -36 -1) at doses of 0, 100, 500 or 1,000 mg/kg-day (Springborn Laboratories, 1995). In another OECD TG 421 study, no reproductive or developmental toxicity was noted in the offspring of rats dosed by oral gavage with octadecene (CAS 27070 -58 -2 and CAS 18236 -02 -8) at doses of 0, 100, 500 or 1000 mg/kg-day (Springborn Laboratories, 2003).

No treatment-related reproductive or developmental effects were observed in the offspring of rats when exposed 6 hours/day to 1000, 5000, or 15,000 mg/m3 isooctene (CAS 11071 -47 -9) in an OECD TG 422 study (BASF, 2007). Both males and females were exposed during the pre-mating (10 weeks) and mating period; females were also exposed during gestation through lactation day 4.  The NOAEL for this study is 15,000 mg/m3.


Short description of key information:
Three OECD 421/422 reproductive developmental toxicity screening tests by oral gavage administration and one combined subchronic (90 day) vapour inhalation study with reproduction/developmental toxicity screening test have been considered. These studies are for C8, C14 and C18 olefins. Results are consistent with no indications of effects on reproduction or development. Furthermore there are no effects on male or female reproductive organs in repeated-dose toxicity studies with C8, C14, C18 or C20/C24 olefins.

Effects on developmental toxicity

Description of key information
In three OECD 421/422 reproductive developmental toxicity screening tests by oral gavage and one combined subchronic (90 day) vapour inhalation study with reproduction/developmental toxicity screening test, there were no effects on pup numbers or survival and no indication of developmental abnormalities.  
Additional information

No reproductive or developmental toxicity studies have been conducted on the butylene oligomers in this category. However, reproductive/developmental toxicity screening studies have been conducted on other higher olefins in the range of C8 to C18. In the oral gavage studies, no reproductive or developmental toxicity was observed at doses up to 1,000 mg/kg-day. Neither was there any reproductive or developmental toxicity observed in rats exposed up to 15,000 mg/m3 (the highest exposure concentration tested).

In a study with 2,4,4 trimethylpentene conducted to OECD 421, groups of 10 male and 10 female rats were dosed orally with 0, 100, 300 or 1000 mg /kg/day (HLS, 1997 c). Treatment was continued throughout mating, gestation and lactation to Day 3 of lactation. There were no effects on the growth and viability of their offspring up to Day 4 of age. In a study conducted with 1-tetradecene to OECD 422, groups of 12 male and 12 female rats were dosed orally with 0, 100, 500 and 1000 mg/kg/day (CAS 1120 -36 -1,Springborn Laboratories, 1995). Mated females were dosed 14 days prior to mating and during mating, gestation and lactation. There were no developmental effects in the Fl generation through day 4 of lactation. In a further OECD 421 study, groups of 12 male and 12 female rats were dosed orally with 0, 100, 500 and 1000 mg C18 octenes /kg/day (CAS 27070 -58 -2 and CAS 182636 -02 -8, Springborn Laboratories, 2003). Females were treated for two weeks prior to mating, during mating, during gestation and following parturition. There were no effects on mean number of live pups per litter, viability (days 0-4), external observations and pup sex ratio on lactation days 0 and 4. In all three studies the no observed adverse effect level (NOAEL) for developmental toxicity was 1000 mg/kg/day, the limit dose for a developmental toxicity study..

Groups of 10 male and 10 female Wistar rats were exposed, whole body, to 0, 1000±100, 5000±200 and 14900±700 mg/m3 isooctene vapour for 6 hours/day, 5 days/week (CAS 11071 -47 -9, BASF, 2007).  Males were exposed for approximately 13 weeks. Females were exposed for approximately 15 weeks including gestation through day 4 after delivery. All pups underwent necropsy on day 4 post partum and were examined macroscopically for external and visceral findings. There were no adverse effects on the development or survival of offspring in the litters of all exposed groups.

Justification for classification or non-classification

There are sufficient data available on representative substances to conclude that members of the butylenes oligomers category are unlikely to have effects on reproduction, fertility or offspring development and do not warrant classification under Dir 67/548/EEC or GHS/CLP.