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EC number: 203-367-7 | CAS number: 106-15-0
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from Secodary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Reproductive toxicity study of test material was performed on rats.
- Author:
- HSDB® - Hazardous Substances Data Bank
- Year:
- 2 018
- Bibliographic source:
- HSDB® - Hazardous Substances Data Bank
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Prenatal development toxicity study(OECD 414)
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study of test material was performed on Sprague-Dawley CD rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Amides, coco, N,N-bis(hydroxyethyl)
- EC Number:
- 271-657-0
- EC Name:
- Amides, coco, N,N-bis(hydroxyethyl)
- Cas Number:
- 68603-42-9
- Molecular formula:
- C13H13Cl8NO4
- IUPAC Name:
- Amides, coco, N,N-bis(hydroxyethyl)
- Details on test material:
- - Name of test material (IUPAC name): Amides, coco, N,N-bis(hydroxyethyl)
- Common name: Coconut diethanolamide
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- No data available
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: arachis oil, DAB 9
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
Test material dissolved in arachis oil, DAB 9
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food )
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): arachis oil, DAB 9
- Concentration in vehicle: 0, 100, 300 and 1000 mg/kg/day
- Amount of vehicle (if gavage): 5ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- Females were mated at the supplier and received at the testing facility on day 0 of gestation.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days ( Days 6 - 15 of gestation)
- Frequency of treatment:
- 7 days/week
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 100, 300 and 1000 mg/kg/day
- No. of animals per sex per dose:
- No data available
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: Animals were observed at least twice daily for signs of reaction to treatment and/or symptoms of illness.
BODY WEIGHT: Yes
Time schedule for examinations: Body weights were recorded on day 0, 6, 16 and 20 of gestation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was determined weekly. - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Live fetuses were weighed individually including placenta and examined for external abnormalities
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)
SACRIFICE : Females were sacrificed by on overdose of
ether on day 20 of gestation
GROSS NECROPSY: The uterus was weighed and the fetuses were removed by caesarean section. Corpora
lutea were counted and the number and distribution of intrauterine implantations were classified as live or dead fetuses, late intrauterine deaths (resorptions), or early intrauterine deaths (resorption sites). Intrauterine deaths were classified on the basis of the presence (late) or absence (early) of fetal or decidual tissue in addition to placental tissue.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.:
macroscopic examination was performed - Postmortem examinations (offspring):
- Postmortem examinations (offspring)
SACRIFICE
One half of the fetuses for each litter were fixed in Bouin’s solution to examine the viscera and brain by Wilson’s slicing technique. After examination these tissues were discarded. The remaining fetuses were processed (alizarin red staining), examined for skeletal abnormalities and retained. - Statistics:
- If normal distribution, Dunnett-Test comparing treated groups to control. The Steel-Test was applied when the data could not be assumed to follow normal distribution. Fisher’s Exact Test for 2 x 2 tables was applied if the variables could be dichotomized without loss of information (Bonferroni-Holm-corrected).
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Compound-related symptoms were observed in all treatment groups as salivation (severe in the 1000 mg/kg/day group) and propulsion of the head
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No deaths occurred in any dams in the control or treated groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weight, body weight gains and corrected body weight gains were comparable across all groups
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- 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:
- no effects observed
- Description (incidence and severity):
- Post-implantation loss and total embryonic deaths were statistically significantly increased in all treated groups compared to the control group. These findings were considered incidental because in each group there was one single female with a high incidence of embryonic deaths and the incidence of post weight loss was not dose dependent.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- reproductive performance
- Remarks on result:
- other: No effects on reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant differences in the body weights of live fetuses (on a litter or individual basis) between the treated and control groups
- 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:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- The sex ratio of the fetuses was not affected by the treatment with the test substance.
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:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- sexual maturation
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: developmental toxic effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) was considered to be 1000mg/kg bw for reproductive and embryo-foetal toxicity. When female Sprague Dawley rats were treated with test material orally.
- Executive summary:
The reproductive and prenatal development toxicity study oftest materialwas performed on female SpragueDawley CD(SD)rats. The test materialdissolved in arachis oil, DAB 9were administered in dose concentration 0, 100, 300 and 1000 mg/kg/dayfrom day 6 through day 15 of gestation by oral gavage route.Dose volume was 5 ml/kg body weight, adjusted for body weighed on day 6 of gestation. Females were mated at the supplier and received at the testing facility on day 0 of gestation. Animals were observed at least twice daily for signs of reaction to treatment and/or symptoms of illness. Body weights were recorded on day 0, 6, 16 and 20 of gestation. Females were sacrificed by on overdose of ether on day 20 of gestation. The uterus was weighed and the fetuses were removed by caesarean section. Corpora lutea were counted and the number and distribution of intrauterine implantations were classified as live or dead foetuses. Live fetuses were weighed individually including placenta and examined for external abnormalities. One half of the fetuses for each litter were fixed in Bouin’s solution to examine the viscera and brain by Wilson’s slicing technique. After examination these tissues were discarded. The remaining fetuses were processed (alizarin red staining), examined for skeletal abnormalities and retained.
No deaths occurred in any dams in the control or treated groups. Compound-related symptoms were observed in all treatment groups as salivation (severe in the 1000 mg/kg/day group) and propulsion of the head. Body weight, body weight gains and corrected body weight gains were comparable across all groups. There were no significant macroscopic findings in any of the control or treated animals. Post-implantation loss and total embryonic deaths were statistically significantly increased in all treated groups compared to the control group. These findings were considered incidental because in each group there was one single female with a high incidence of embryonic deaths and the incidence of post weight loss was not dose dependent. The sex ratio of the fetuses was not affected by the treatment with the test substance. There were no significant differences in the body weights of live fetuses (on a litter or individual basis) between the treated and control groups. There were no external macroscopic findings noted in any fetus that were considered to be an effect of the treatment with the test article. Visceral examinations of the preserved fetuses did not reveal any treatment-related abnormalities. Statistically significant retardation in ossification was observed in the 300 and 1000 mg/kg/day groups compared to the controls. The incidence of two sternebrae unossified was significantly increased in the 300 and 1000 mg/kg/day groups compared to the control group. The incidence of incomplete ossification of the skull bones was also significantly increased in the 1000 mg/kg/day group compared to the control group but was essentially due to two dams, which had a total of 10 incomplete ossified skull bones of the 17 observed for this group. The skeletal retardation effects were considered to be incidental because the values were within the normal range of variation for this strain. Hence No Observed Adverse Effect Level (NOAEL) was considered to be 1000mg/kg bw for reproductive and embryo-foetal toxicity.When femaleSprague Dawley rats were treated withtest material orally.
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