Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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 TSCA
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening in rats
- 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
- Details on test material:
- SMILES:CCCCCCCCCCCC#N
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Dodecanenitrile
- Molecular formula (if other than submission substance): C12H23N
- Molecular weight (if other than submission substance): 181.321 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 47 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- not specified
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: yes
BODY WEIGHT: Yes
Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data - Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- Survival and body weight were examined.
- Postmortem examinations (parental animals):
- Organ weight and Gross pathology were examined.
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- viability index were examined.
- Offspring viability indices:
- yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 1000 mg/kg bw, After giving birth 4 dams died spontaneously on day 1 post partum.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 1000 mg/kg bw, mean body weight gain were decreased in male rat and during the lactation period in female rat.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 1000 mg/kg bw, mean food consumption gain were decreased in male rat and during the lactation period in female rat.
- 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:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 50 mg/kg bw, one female was not pregnant.
When treated with 100 mg/kg bw, no mating was observed for one female.
When treated with 1000 mg/kg bw, two females were not pregnant and 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.
Statistically significant decrease in birth and viability index were observed in treated rats as compared to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- organ weights and organ / body weight ratios
- gross pathology
- reproductive performance
- other: No effect observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Description (incidence and severity):
- When treated wtih 1000 mg/kg bw, Statistically significant decrease in viability index were observed in treated rats as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated wtih 1000 mg/kg bw, pup body weight were 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.
When treated with 50 and 250 mg/kg bw, Body weights of male and female pups were slightly decrease on day 1 post partum and similar to the control on day 4 post partum. Since there were more pups per litter in these groups this is considered to be incidental. - Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- body weight and weight gain
- other: No effect observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effect level (NOAEL) was considered to be 250 mg/kg for P and F1 generation when male and female rats were treated with Dodecanenitrile orally by gavage for 47 days.
- Executive summary:
In Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening test, male and female rats were treated with Dodecanenitrile in the concentration of 0, 50, 250 and 1000 mg/kg bw orally by gavage for 47 days (mating period, gestation and early lactation phase). At 1000 mg/kg bw, After giving birth 4 dams died spontaneously on day 1 post partum. Mean body weight gain and food consumption were decreased in male rat and during the lactation period in female rat at 1000 mg/kg bw. One female was not pregnant at 50 mg/kg bw, no mating was observed for one female at 100 mg/kg bw and two females were not pregnant and one female was killed in extremis on day 3 of the gestation at 1000 mg/kg bw. 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. Statistically significant decrease in birth and viability index was observed in 1000 mg/kg bw treated rats as compared to control. Similarly, statistically significant increase in liver weights was observed in male rats. For female, due to the fact that there was only one female, no conclusion could be reached concerning liver weights at 1000 mg/kg bw. Increase in liver weights were observed in 50 and 250 mg/kg bw treated female rats, but not statistically significantly and not dose dependently. Unexpected black-brown contents in stomach, intestine and/or caecum were observed in all groups, which were considered not to be test item-related. In addition, statistically significant decrease in viability index were observed in treated rats at 1000 mg/kg bw as compared to control. At 1000 mg/kg bw, pup body weight were 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 50 and 250 mg/kg bw, Body weights of male and female pups were slightly decrease on day 1 post partum and similar to the control on day 4 post partum. Since there were more pups per litter in these groups this is considered to be incidental. Therefore, No adverse effect level (NOAEL) was considered to be 250 mg/kg for P and F1 generation when male and female rats were treated with Dodecanenitrile orally by gavage for 47 days.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.