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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Screening-level information is available on the toxicity to reproduction of the following members of this category:

 

Test substance identity

Testing for Reproductive Effects

Hex-1-ene

v

Alkenes, C6

v

Tetradec-1-ene

v

Octadecene

v

 

Details of these studies are summarised below.

Information is available from an OECD 421 screening study that investigated the developmental and reproductive toxicity of 1-hexene. Supporting information is available from a 90-day inhalation test.

In the screening study (Daniel, 1995b), hex-1-ene was administered via gavage to twelve Sprague-Dawley rats/sex/dose at doses of 0, 100, 500, or 1000 mg/kg/day. Males were treated for 44 days beginning 28 days prior to mating and females were treated for 41 to 55 days beginning 14 days prior to mating through lactation day 4. No reproductive effects were observed. There was a slight, but significant, decrease in absolute epididymal weight at all concentrations compared to the controls. The relative epididymal to brain weight was only significantly decreased in the low-dose group. Although the absolute epididymal weight was significantly decreased in parental males, the change was within 10% of the control, there was no dose response, there was no effects noted microscopically, and there were no effects on fertility. Therefore, this was not considered to be toxicologically significant. The NOAEL for reproductive toxicity was 1000 mg/kg/day, the highest dose tested.

In the 90-day inhalation study (Bennick et al., 1984), hex-1-ene was administered to forty Fischer 344 rats/sex/concentration by dynamic whole body exposure at concentrations of 0, 300, 2000, or 3000 parts per million (equivalent to 0; 1033; 3442; and 10,326 mg/m3, respectively) for 6 hours a day, 5 days a week, for 13 weeks. According to the report, there were no effects on sperm count after exposure.

Information is available from an OECD 422 screening study that has investigated the repeated dose and developmental toxicity of Alkenes C6.

In this investigation (Thorsud, 2003), Alkenes, C6 dissolved in corn oil was administered via oral gavage to F0 male and female Sprague-Dawley rats at dose levels of 0, 100, 500 and 1000 mg/kg/day for at least 4 weeks. There was no mortality or adverse signs of toxicity observed at any dose level and F0 mating, fertility indices, mean gestation lengths, mean number of pups delivered, F1 live birth index, F1 viability index, F1 pups per litter, and F1 pup sex ratios were comparable between control and treatment groups. Gross necropsy of F0 females revealed no significant treatment-related findings. Organ weight determinations in F0 rats did not reveal any significant difference between treatment and control animals. Based on the lack of significant adverse clinical effects, the reproductive toxicity NOAEL for alkenes, C6 was reported as 1000 mg/kg/day. 

Information is available from an OECD 422 screening study that has investigated the repeated dose and reproductive toxicity of Alkenes C6.

In a study (Daniel, 1995a), tetradec-1-ene was administered via gavage to twelve Sprague-Dawley Crl:CDBR VAF/Plus rats/sex/dose at doses of 0, 100, 500, or 1000 mg/kg/day as a solution in corn oil. Males were treated for 43 to 47 days beginning 28 days prior to mating and females were treated for 42 to 51 days beginning 14 days prior to mating through lactation day 4. No reproductive effects were observed. The NOAEL for reproductive toxicity was 1000 mg/kg/day.

Information is available from an OECD 421 that investigated the developmental and reproductive toxicity of octadecene.

In this investigation (Thorsud, 2003), octadecene (dissolved in corn oil) was administered to Sprague-Dawley rats (12 sex/dose) by gavage at dose levels of 0, 100, 500, or 1000 mg/kg/day for 42 days. There was no mortality observed in animals in the control, 100, 500, or 1000 mg/kg dose group. Parental female mating, fertility, and mean gestation lengths were observed to be comparable with controls as were the mean number of pups delivered and live birth and viability indices. Mean live pups/litter and sex ratio/litter were also found to be normal and comparable to those observed in control animals. Gross necropsy revealed no remarkable differences between octadecene-treated and control animals. There were no microscopic lesions observed in male or female rats treated with octadecene and no statistically significant differences in absolute or relative epididymides weight were apparent in treated males when compared with control males. Based on the lack of adverse systemic effects observed in the study, the reproductive toxicity NOAEL for octadecene was reported as 1000 mg/kg/day.


Short description of key information:
Oral screening level information, supported by results from a 90-day sub-chronic inhalation study, is available on the potential of 4 members of this category, covering C6 to C18, to cause reproductive toxicity. No effects on reproduction were observed in male or female rats receiving oral treatments at dose levels up to 1000 mg/kg bw/day, or inhalation exposures up to 10,326 mg/m3.

Justification for selection of Effect on fertility via oral route:
Oral screening level information, supported by results from a 90-day sub-chronic inhalation study, is available on the potential of 4 members of this category, covering C6 to C18, to affect reproduction and fertility. No effects were observed in male or female rats receiving oral treatments at dose levels up to 1000 mg/kg bw/day, or inhalation exposures up to 10,326 mg/m3.

Effects on developmental toxicity

Description of key information
Oral screening level information is available on the potential of 4 members of this category, covering C6 to C18, to cause developmental toxicity. No developmental effects were observed in female rats treated for the duration of pregnancy at dose levels up to 1000 mg/kg bw/day.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Screening-level information is available on the developmental toxicity of the following members of this category:

 

Test substance identity

Testing for Developmental Effects

Hex-1-ene

v

Alkenes, C6

v

Tetradec-1-ene

v

Octadecene

v

 

Details of these studies are summarised below.

Information is available from an OECD 421 screening study that investigated the developmental and reproductive toxicity of 1-hexene.

In this investigation (Daniel, 1995), hex-1-ene was administered via gavage to twelve Sprague-Dawley rats/sex/dose at doses of 0, 100, 500, or 1000 mg/kg/day. Males were treated for 44 days beginning 28 days prior to mating and females were treated for 41 to 55 days beginning 14 days prior to mating through lactation day 4. No developmental effects were observed. Therefore, the NOAEL for developmental toxicity was 1000 mg/kg/day.

Information is available from an OECD 422 screening study that has investigated the repeated dose and developmental toxicity of Alkenes C6.

In this study (Thorsud, 2003), Alkenes, C6 dissolved in corn oil was administered via oral gavage to F0 male and female Sprague-Dawley rats at dose levels of 0, 100, 500 and 1000 mg/kg/day for at least 4 weeks. There were no adverse signs of toxicity observed at any dose level and the mean number of pups delivered, F1 live birth index, F1 viability index, F1 pups per litter, and F1 pup sex ratios were comparable between control and treatment groups. Based on the lack of significant adverse clinical effects, the developmental toxicity NOAEL for Alkenes, C6 was 1000 mg/kg/day.

Information is available from an OECD 422 screening study that investigated the repeated dose and developmental toxicity of 1-tetradecene.

In a study (Daniel, 1995), tetradec-1-ene was administered via gavage to twelve Sprague-Dawley Crl:CDBR VAF/Plus rats/sex/dose at doses of 0, 100, 500, or 1000 mg/kg/day as a solution in corn oil. Males were treated for 43 to 47 days beginning 28 days prior to mating and females were treated for 42 to 51 days beginning 14 days prior to mating through lactation day 4. No developmental effects were observed. The NOAEL for developmental effects was 1000 mg/kg/day.

Information is available from an OECD 421 that investigated the developmental and reproductive toxicity of octadecene.

In this investigation (Thorsud, 2003), octadecene (dissolved in corn oil) was administered to Sprague-Dawley rats (12 sex/dose) by gavage at dose levels of 0, 100, 500, or 1000 mg/kg/day for 42 days. Mean live pups/litter and sex ratio/litter were also found to be normal and comparable to those observed in control animals. Gross necropsy revealed no remarkable differences between octadecene-treated and control animals. There were no statistically significant differences observed in pup weights on lactation days 1 and 4 and gross necropsy of the pups on lactation day 4 revealed no treatment-related effects. Based on the lack of adverse systemic effects observed in the study, the developmental toxicity NOAEL for octadecene was 1000 mg/kg/day.


Justification for selection of Effect on developmental toxicity: via oral route:
Oral screening level information is available on the potential of 4 members of this category, covering C6 to C18, to cause developmental toxicity. No developmental effects were observed in female rats treated for the duration of pregnancy at dose levels up to 1000 mg/kg bw/day.

Justification for classification or non-classification

Oral reproductive screening studies have been conducted for 4 members of this category, covering C6 to C18. This information provides no evidence of effects on development or reproduction, and no classification is necessary according to the CLP regulation.