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Diss Factsheets
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EC number: - | 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: 28-day repeated dose oral study with extended histopathology of the sex organs and spermatology
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August 2011 to March 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: extended OECD 407 repeated dose study
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- see section on repeated dose toxicity.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- see section on repeated dose toxicity.
- Details on mating procedure:
- No mating extended histopathology of sex organs.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- see section on repeated dose toxicity.
- Duration of treatment / exposure:
- 28-days
- Frequency of treatment:
- Daily
- Details on study schedule:
- see repeated dose toxicity section.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
30 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
300 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- see repeated dose toxcicity section.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- see repeated dose toxcicity section.
Examinations
- Parental animals: Observations and examinations:
- see repeated dose toxcicity section.
- Oestrous cyclicity (parental animals):
- not determined
- Sperm parameters (parental animals):
- Sprem stages and interstitial structure were specifically investigated.
- Litter observations:
- not applicable
- Postmortem examinations (parental animals):
- Testes and epididymes preserved in Bouin's fluid. Sections were stained with heamatoxilin/eosin as well as for testes and epididymes with Periodic acid/Schiff's (PAS) stain.
- Postmortem examinations (offspring):
- not applicable
- Statistics:
- see repeated dose toxcicity section.
- Reproductive indices:
- not applicable
- Offspring viability indices:
- not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- see repeated dose toxcicity section.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- see repeated dose toxcicity section.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- see repeated dose toxcicity section.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- no effects on sex organs, other see repeated dose toxcicity section.
- Other effects:
- no effects observed
- Description (incidence and severity):
- Test substance intake: see repeated dose toxcicity section.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- no effects on completeness of stages, maturation, reabsorption or degeneration
- Reproductive performance:
- not examined
Details on results (P0)
The sperm staging gave the following results: The tet item did not reveal effects on the completeness of stages or cell populations. No inidcation of maturation arrest, resorption of sperm or any degenerative type of effect was observed.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Weight of sex organs, histopathology of sex organs, sperm staging.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The repeated dose study with an extended histopatholgy of the male sex organs including sperm staging did not reveal any test substance related effects on the sex organs up to the highest dose tested. This indicates that on a screening level ther is no immediate concern for possible effects on fertility.
- Executive summary:
In a 28 -day oral gavage study in rats receiving up to 1000 mg/kg bw of the test item per day for 28 consecutive days, no effects on male and female sex organs was observed. The study included an an extended histopatholgy of the male sex organs including sperm staging .No test substance related effects on the sex organs up to the highest dose tested were observed. This indicates that on a screening level there is no immediate concern for possible effects on fertility.
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.
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