Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 203-079-1 | CAS number: 103-09-3
- 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

Specific investigations: other studies
Administrative data
- Endpoint:
- biochemical or cellular interactions
- Type of information:
- other: experimental result
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication/study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Effects of DEHP and five of its metabolites including 2-EH on rat testis in vivo and in vitro
- GLP compliance:
- not specified
- Endpoint addressed:
- toxicity to reproduction / fertility
Test material
- Reference substance name:
- Bis(2-ethylhexyl) phthalate
- EC Number:
- 204-211-0
- EC Name:
- Bis(2-ethylhexyl) phthalate
- Cas Number:
- 117-81-7
- Molecular formula:
- C24H38O4
- IUPAC Name:
- bis(2-ethylhexyl) phthalate
- Details on test material:
- - Name of test material (as cited in study report):
- 2-EH
- Other test substances examined in the same study:
DEHP
MEHP
Metabolite IX (mono-2-ethyl-hexanol-6-hexanoic acid)-phthalate; w-oxidation product of MEHP)
Metabolite VI (mono-2-ethyl-5-keto-hexanol)-phthalate
Metabolite V (mono-2-ethyl-5-hydroxy-hexanol)-phthalate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: propylene glycol (MEHP and MEHP-metabolites; DEHP and 2-EH: suspension without vehicle
- Duration of treatment / exposure:
- 5 exposures
- Frequency of treatment:
- 1/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2.7 mmol/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 animals per test substance
- Control animals:
- yes, concurrent vehicle
Examinations
- Examinations:
- In vivo: metabolite blood levels (excluding 2-EH). Absolute and relative testes and prostate weight; degenerate dcells in seminiferous tubules.
In vitro: germ cell detachment in primary rat testicular cell cultures.
Results and discussion
- Details on results:
- Degeneration of testes and Sertoli cells were not associated with 2 -EH, but with MEHP, which is generated following the administration of DEHP.
Any other information on results incl. tables
In vivo: Five of six rats receiving MEHP had a much higher frequency of degenerating cells (degenerated spermatocytes and spermatids) in the seminiferous tubules, compared to the control animals or rats receiving DEHP, 2 -EH, or the metabolites of MEHP. Therefore, no testicular damage was observed in animas given 2 -EH. In vitro: Germ cell detachment was significantly increased in primary rat testicular cell cultures when MEHP was adminsitered at concnetrations oft 1 µM and above (Table). DEHP and 2 -EH administered at 200 µM were not different from controls at 24 and 48 hours.
Applicant's summary and conclusion
- Conclusions:
- MEHP is the metabolite that is responsible for the testicular damage that is observed following administration of DEHP to rats.
2-EH has no adeverse effect on testis, germ cell detachment in vivo or in vitro. - Executive summary:
In was shown vivo and also in primary rat testicular cell cultures in vitro that MEHP was the metabolite that causes testicular damage following administration of DEHP. MEHP caused a significantly increased germ cell detachment in vitro at 1 µM and above, whereas effcts of 200 µM DEHP and 2 -EH were not different from controls after 24 or 48 hour incubation in vitro (Sjöberg et al., 1986).
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