Registration Dossier
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EC number: 217-316-1 | CAS number: 1809-19-4
- 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:
- reproductive toxicity, other
- Remarks:
- 90-day repeated dose toxicity study examining some fertility parameters
- Type of information:
- other: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 27 December, 1978, to 26 March, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- Justification for Read Across is provided in Section 13 of IUCLID
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 408 90 day repeated dose toxicity study in rodents
- Deviations:
- no
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Source Chemical 01
- IUPAC Name:
- Source Chemical 01
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI, USA).
- Age at study initiation: 6-8 weeks old.
- Weight at study initiation: 23-25 g (male), 18-19 g (female).
- Housing: 5 animals per cage (polycarbonate).
- Diet (e.g. ad libitum): Purina Lab Chow meal (St. Louis, MO); available ad libitum.
- Water (e.g. ad libitum): Acidified with HCl (pH 2.5) tap water; available ad libitum.
- Acclimation period: 2 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24 (max 28).
- Humidity (%): 30-70
- Air changes (per hr): 12-15 room air changes/h.
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Appropriate amounts of test item were mixed with corn oil. Mixtures were resuspended before dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil was chosen because of the potential for chemical hydrolysis in water.
- Concentration in vehicle: 0, 28.53, 57.06, 112.61, 225.22, 450.45 mg/mL
- Amount of vehicle: 3.33 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analytical verification of doses or concentrations: Analyses of the test item in corn oil were performed on every eighth dose mixture to confirm that the correct concentrations were administered to the test animals. The method of analysis involved a methanolic extraction as a purification step and a gas chromatographic assay as a quantification step.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily, 5 days a week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 90 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 190 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 375 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 750 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 500 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- - Clinical signs:twice per day
- Mortality: twice per day
- Body weight: weekly
- Organ weight: no
- Food consumption: no
- Water consumption: no
- Haematology: no
- Biochemistry: no
- Urinalysis: no - Postmortem examinations (parental animals):
- Necropsy performed on all animals; the following tissues from vehicle control and all but the 95 mg/kg bw dosed group of mice were microscopically examined: gross lesions, skin , parathyroids, colon, esophagus, brain, sternebrae (including marrow), liver, lung and mainstem bronchi, stomach, thymus, pancreas, kidney, urinary bladder, eyes, mandibular lymph node, saliva glands, thyroid gland, small intestine, ovaries/ uterus or prostate / testes, heart, trachea, spleen, adrenal glands, pituitary gland, gallbladder, mammary gland. Only heart, liver, and kidney examined for the 95 mg/kg group of mice.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- final weights of surving dosed and vehicle control mice were comparable
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- final weights of surving dosed and vehicle control mice were comparable
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- not examined
Details on results (P0)
All the mice of each sex that received the higher doses of 750 or 1500 mg/kg died during the first 4 weeks. 2 of the 10 males and 5 of 10 females that received 375 mg/kg also died. Mice that received 375 mg/kg or more had tremors and decreased activity. Final weights of surviving dosed and vehicle control mice were comparable. Lung congestion in males and females, cardiac mineralization in males, and hepatocellular vacuolization in females were probably compound related. Pulmonary congestion was observed in animals that died during the studies. Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg.
These effects were probably secondary to the general toxicity.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 190 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg. These effects were probably secondary to the general toxicity.
- Dose descriptor:
- LOAEL
- Remarks:
- reproductive toxicity
- Effect level:
- 375 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg. These effects were probably secondary to the general toxicity.
Target system / organ toxicity (P0)
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 375 mg/kg bw/day (actual dose received)
- System:
- male reproductive system
- Organ:
- testes
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL (reproductive, mouse, male) = 190 mg/kg bw/day
LOAEL (reproductive, mouse, male) = 375 mg/kg bw/day (testes) - Executive summary:
The toxicity to reproduction is able to be assessed using the data obtained from a 90-day repeated dose toxicity experimental study performed according to a method equivalent to the OECD Guideline 408. Groups of 10 male and 10 female B6C3F1 mice were administered the test item in corn oil at doses of 90, 190, 375, 750 or 1500 mg/kg bw/day alongside a vehicle control group five days a week for 90 days.
All the mice of each sex that received the higher doses of 750 or 1500 mg/kg bw/day died during the first 4 weeks. 20 % of males and 50 % of females that received 375 mg/kg bw/day also died. Mice that received 375 mg/kg bw/day or more had tremors and decreased activity. Final weights of surviving dosed and vehicle control mice were comparable. Lung congestion in males and females, cardiac mineralisation in males, and hepatocellular vacuolisation in females were probably compound related. Pulmonary congestion was observed in animals that died during the studies. Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg. These effects were probably secondary to the general toxicity.
Based on the testicular atrophy, hypospermatogenesis and formation of large giant spermatids and sincytial cells in males at the three highest doses, the NOAEL for reproductive toxicity can be set at 190 mg/kg bw/day.
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