Registration Dossier
Registration Dossier
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EC number: 628-856-6 | CAS number: 1218787-29-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
A combined repeated dose/reproduction screening toxicity study according to OECD 422 has been performed with Dodecanenitrile (CAS 2437-25-4). As C12 is about the average and represents the major part of the range of alkyl chains in coco (45 -62%), these results provide a rather good indication of the possible hazards to reproduction of Coconitrile. The NOAEL for reproductive effects from this study is 250 mg/kg, based on death and poor health of the females at 1000 mg/kg. At 1000 mg/kg/day, two of the ten females were not pregnant, and seven females died or were killed for ethical reasons during or directly after giving birth or by day 4 post partum, leaving just one animal that reared her pups until day 4 pp.
Reproductive performance: precoital time, duration of gestation, and number of implantations were not affected at 1000 mg/kg.
Short description of key information:
NOAEL = 250 mg/kg bw/day
Effects on developmental toxicity
Description of key information
NOAEL = 250 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
Additional information
A combined repeated dose/reproduction screening toxicity study according to OECD 422 has been performed with Dodecanenitrile (CAS 2437-25-4). As C12 is about the average and represents the major part of the range of alkyl chains in coco (45 -62%), these results provide a rather good indication of the possible hazards to reproduction of Coconitrile. The NOAEL for reproductive effects from this study is 250 mg/kg, based on death and poor health of the females at 1000 mg/kg. At 1000 mg/kg/day, two of the ten females were not pregnant, and seven females died or were killed for ethical reasons during or directly after giving birth or by day 4 post partum, leaving just one animal that reared her pups until day 4 pp.
Developmental related effects observed included increased incidence of post implantation loss, reduced mean litter size, increased incidence of dead pups at first litter check and increased incidence of postnatal loss. Only when calculated for all dams giving birth the incidence of postnatal loss was statistically significantly increased in group 4. This increase was considered to be treatment related. When calculated for all dams with live pups on day 4 post partum the incidence of postnatal loss of the remaining single female in group 4 was not increased.
Examinations of pups during gross pathology did not show indications of possible congenital malformations, but then again no full histopathology has been performed on the pups.
Justification for classification or non-classification
The combined repeated dose/reproduction screening toxicity study with Dodecanenitrile (CAS 2437-25-4) showed no effects up to levels showing maternal toxicity. Higher dose levels resulted to high maternal toxicity causing death of most of the dams, and effects seen in pups are likely subsequent to maternal toxicity. No macroscopic malformations have been observed in the pups. The highest non-lethal dose remained without effect on reproduction parameters.
Additional information
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