Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-211-0 | CAS number: 117-81-7
- 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: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, acceptable with retrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Testicular toxicity of di(2-ethylhexyl) phthalate in developing rats.
- Author:
- Parmar, D., Srivastava, S.P., Srivastava, S.P.
- Year:
- 1 995
- Bibliographic source:
- Vet. Human. Toxicol. 37, 310-313.
Materials and methods
- Principles of method if other than guideline:
- Investigation of the activities of the testicular enzymes associated with spermatogenesis
- Type of method:
- in vivo
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:
- 1,2-bis(2-ethylhexyl) benzene-1,2-dicarboxylate
- Details on test material:
- DEHP (purity not specified)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: groundnut oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 30 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 100, 250 or 500 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 male rats per dose group
- Control animals:
- yes
Results and discussion
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 50 mg/kg bw/day
- Sex:
- male
- Basis for effect level:
- other: effects on absolute and relative testis weight, and reduced testicular enzyme activities
Observed effects
From 50 mg/kg also a dose-dependent and significant increase in the activities of LDH and GGT was noted while that of SDH decreased.
β-glucuronidase increased at 250 or 500 mg DEHP/kg, while acid phosphatase decreased at the same dose levels.
The administration also resulted in marked destructive changes in the advanced germ cell layers and marked degrees of vacuolar degeneration in the testes at 250 and 500 mg/kg bw.
The significant alterations in the activities of SDH, LDH, and GGT occurred thus at much lower DEHP levels and prior to the histopathological changes. The Leydig cells and the fibroblasts appeared normal.
Applicant's summary and conclusion
- Executive summary:
The activities of the testicular enzymes associated with spermatogenesis including LDH, GGT, SDH, β-glucuronidase, and acid phosphatase were studied in a similar study investigating the oral effect of DEHP on 25 day old male Wistar rats. Doses of 0, 50, 100, 250 or 500 mg/kg bw of DEHP (purity not specified) in groundnut oil were given for 30 consecutive days to 6 male rats per dose group. There was an exposure-related and significant decrease of absolute and relative testicular weight at all dose levels. From 50 mg/kg also a dose-dependent and significant increase in the activities of LDH and GGT was noted while that of SDH decreased. β-glucuronidase increased at 250 or 500 mg DEHP/kg, while acid phosphatase decreased at the same dose levels. The administration also resulted in marked destructive changes in the advanced germ cell layers and marked degrees of vacuolar degeneration in the testes at 250 and 500 mg/kg bw. The significant alterations in the activities of SDH, LDH, and GGT occurred thus at much lower DEHP levels and prior to the histopathological changes. The Leydig cells and the fibroblasts appeared normal.
A LOAEL for young rats of 50 mg/kg bw/day is derived from this study for effects on absolute and relative testies weight, and reduced testicular enzyme activities.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.