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Diss Factsheets
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EC number: 941-188-2 | CAS number: -
- 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:
- toxicity to reproduction
- Remarks:
- other: Repeat dose toxicity study with histopathology of reproductive organs.
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientific principles and provides screening data for reproductive endpoints
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Wistar-SLC rats were fed for 3 months with test substance mixed into theIr food at a level of 0%, 0.2%, 1.0% or 5.0%. Clinical symptoms, body weights, food and water intake, food efficiency, blood analysis, urine analysis and blood enzymes were evaluated along with gross appearance, weight and pathology of tissues from a wide range of organs, including the reproductive organs.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 75782-87-5
- EC Number:
- 616-261-4
- Cas Number:
- 75782-87-5
- IUPAC Name:
- 75782-87-5
- Details on test material:
- - Name of test material (as cited in study report): Dobanol-45
- Substance type: technical product
- Physical state: not reported
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: Tradename Dobanol 45 C14-16 alcohols Type A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wister-SLC
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: 5 weeks
- Weight at study initiation: no data
- Fasting period before study: no data
- Housing: "cages" (no further details given)
- Diet (e.g. ad libitum): CE-2, made by Nihon Kurea, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 2 degrees centigrade
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): no data
- Mixing appropriate amounts with (Type of food): CE-2 solid food, made by Nihon Kurea
- Storage temperature of food: no data - Details on mating procedure:
- Animals were not mated.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure period: 90 days
- Frequency of treatment:
- continuously
- Details on study schedule:
- No schedule: animals were not mated.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 0.2, 1.0, and 5.0%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0, 169, 702, 3548 mg/kg bw/day (average)
Basis:
actual ingested
- No. of animals per sex per dose:
- 11
- Control animals:
- yes, concurrent no treatment
Examinations
- Postmortem examinations (parental animals):
- SACRIFICE
- at 90 days
HISTOPATHOLOGY / ORGAN WEIGHTS
- thyroid, testes or ovaries - Statistics:
- STATISTICAL METHODS: Student t test.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- On testes and ovaries
- Other effects:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: At the highest dose level of 5% in the diet, absolute weights of testes and ovaries were not affected; the microscopic appearance of these organs was normal.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The effects below refer to relative organ weights, but it is usual to evaluate absolute organ weights for the reproductive organs.
There were increases in both testes and ovary weights (p<0.1) at the top dose level of 5% (ca 3500 mg/kg/day). Testes weight was also increased at the 1% dose level (p<0.05).
The NOAEL determined below is derived from the relative weight of the reproductive organs, whereas there were no effects on absolute weight of reproductive organs at the highest dose tested:
The NOAEL for systemic toxicity and effects on the reproductive organs is 0.2% in the diet (ca 200 mg/kg/day)
(males 171 mg/kg/day; Females 167 mg/kg/day).
Applicant's summary and conclusion
- Conclusions:
- In a reliable study, conducted using a protocol similar to OECD guideline 408, male and female rats were fed diets containing 0, 0.2%, 1% or 5% Dobanol-45 for 90 dyas. An NOAEL of 5% (equivalent to a dose of 3605 mg/kg bw/day in males and 3491 mg/kg bw/day in females) was identified since there were no effects on absolute weights of the testes or ovaries, or on the microscopic appearance of these organs, even at the highest dose level.
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