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EC number: 219-440-1 | CAS number: 2437-25-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Reproductive toxicity of CAS no 2437-25-4
- Author:
- TSCA
- Year:
- 2 006
- Bibliographic source:
- US Environmental Protection Agency, TSCA, June 12,2006,
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the toxic potential of Dodecanenitrile in male and female rats by oral gavage for 47 days.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dodecanenitrile
- EC Number:
- 219-440-1
- EC Name:
- Dodecanenitrile
- Cas Number:
- 2437-25-4
- Molecular formula:
- C12H23N
- IUPAC Name:
- dodecanenitrile
- Test material form:
- liquid
- Details on test material:
- - Name of test material (IUPAC name): Dodecanenitrile
- Molecular formula: C12H23N
- Molecular weight: 181.321 g/mole
- Smiles notation: C(CCCCCC)CCCCC#N
- InChl: 1S/C12H23N/c1-2-3-4-5-6-7-8-9-10-11-12-13/h2-11H2,1H3
- Substance type: Organic
- Physical state: colourless liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Dodecanenitrile
- Molecular formula :C12H23N
- Molecular weight :181.321 g/mol
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration of treatment / exposure:
- Forty seven days which included a mating period, gestation and early lactation phase.
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 50, 250 and 1000 mg/kg bw
- No. of animals per sex per dose:
- Not specified.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified.
- Positive control:
- Not specified.
Examinations
- Observations and examinations performed and frequency:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Not specified
CLINICAL CHEMISTRY: Not specified
URINALYSIS: Not specified
NEUROBEHAVIOURAL EXAMINATION: Not specified - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Not specified.
- Statistics:
- Not specified.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical sign; Statistically significant change as 2 females were not pregnant was observed at the dose level of 1000 mg/kg bw/day.
At the dose level of 250 mg/kg bw/day, no mating was observed for one female.
At the dose level of 50 mg/kg bw/day, one female was not pregnant. - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Mortality; At the dose level of 1000 mg/kg bw/day one female was killed in extremis on day 3 of the gestation. After giving birth 4 dams died spontaneously on day 1 post partum and two dams were killed in extremis on days 1 and 4 post partum, respectively.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight ; At the dose level of 1000 mg/kg bw/day mean body weight gain for males were reduced in the Pre-pairing period.
Furthermore, a body weight loss was observed during the lactation period in female at 1000 mg/kg bw/day group compare to control. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption; At the dose level of 1000 mg/kg bw/day mean food consumption for males were reduced in the pre-pairing period. For females, mean food consumption was slightly reduced in the pre-pairing and gestation period and distinctly during the lactation period.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical sign; Statistically significant change as 2 females were not pregnant was observed at the dose level of 1000 mg/kg bw/day.
At the dose level of 250 mg/kg bw/day, no mating was observed for one female.
At the dose level of 50 mg/kg bw/day, one female was
not pregnant.
Mortality; At the dose level of 1000 mg/kg bw/day one female was killed in extremis on day 3 of the gestation. After giving birth 4 dams died spontaneously on day 1 post partum and two dams were killed in extremis on days 1 and 4 post partum, respectively.
Body weight ; At the dose level of 1000 mg/kg bw/day mean body weight gain for males were reduced in the
Pre-pairing period.
Furthermore, a body weight loss was observed during the lactation period in female at 1000 mg/kg bw/day group compare to control.
In the dose level of 1000 mg/kg bw/day ,pup body weight seemed to be slightly reduced on day 1 post partum but distinctly reduced on day 4 post partum; however the results were based only on the data of one litter.
At the dose level of 250 and 50mg/kg bw/day, Body weights of male and female pups were slightly reduced on day 1 post partum and similar to the control on day 4 post partum.
Food consumption; At the dose level of 1000 mg/kg bw/day mean food consumption for males were reduced in the pre-pairing period. For females, mean food consumption was slightly reduced in the pre-pairing and gestation period and distinctly during the lactation period.
Organ weight;At the dose level of 250 and 50mg/kg bw/day, Body weights of male and female pups were slightly reduced on day 1 post partum and similar to the control on day 4 post partum.
Gross pathology ;At the dose level of 1000 mg/kg bw/day statistically significant increase in liver weights was observed in male compare to control.
In 1000 mg/kg bw/day group, due to the fact that there was only one female, no conclusion could be reached concerning liver weights.
At the dose level of 250 and 50 mg/kg bw/day, increase in liver weights was observed in female compare to control but not statistically significantly and not dose dependently.
At the dose level of 1000 mg/kg bw/day statistically significant increase in liver size was observed in male compare to control.
For both sexes, unexpected black-brown contents in stomach, intestine and/or caecum were noted in 0, 50, 250 and 1000 mg/kg bw groups, which were considered not to be test item-related.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 250 other: mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No statically significant effects were observed in clinical sign, mortality, body weight, food consumption, Organ weight and gross pathology.
- Remarks on result:
- other: No toxiceffect were observed
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 250 mg/kg bw/day for Dodecanentirile (2437-25-4) in male and female rats by oral gavage for 47 days repeated dose study.
- Executive summary:
Repeated dose oral toxicity study forDodecanentirile was conducted inmale and female rats for 47 days by oral gavage. The test substance was exposed at the concentration of 0, 50, 250 and 1000 mg/kg bw/day. Statisticallysignificant clinical change, as 2 females were not pregnant was observed at the dose level of 1000 mg/kg bw/day. At the dose level of 1000 mg/kg bw/day one female was killed in extremis on day 3 of the gestation. After giving birth 4 dams died spontaneously on day 1 post partum and two dams were killed in extremis on days 1 and 4 post partum, respectively. At the dose level of 1000 mg/kg bw/day statistically significant increase in liver weights was observed in male compare to control. At the dose level of 1000 mg/kg bw/day statistically significant increase in liver size was observed in male compare to control. No statistically significant and not dose dependent effect were observed in clinical sign, mortality, body weight, food consumption, Organ weight and gross pathology at dose level of 250 and 50 mg/kg bw/day. Therefore NOAEL was considered to be 250mg/kg bw/day forDodecanentirilein male and female rats by oral gavage for 47 days repeated dose study.
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