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EC number: 202-377-9 | CAS number: 94-96-2
- 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
Carcinogenicity
Administrative data
Description of key information
No site-specific increase in tumour formation was observed after dermal treatment of EHD over a lifetime in mice.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Experimental data in a peer-reviewed journal
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Precedes establishment of OECD guideline. The method was used previously by Hartwell, JL, 1951, Survey of Compounds Which Have Been Tested for Carcinogenic Activity, PHS publication 149, U.S. Government Printing Office, Washington, DC, USA.
- GLP compliance:
- no
- Remarks:
- Precedes establishment of GLP
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Epply colony, Epply Institute for Research in Cancer, University of Nebraska Medical Center, Omaha, NE, 68105, USA.
- Age at study initiation: 7 weeks
- Randomized; litter mates were separated.
- 10/cage, in plastic cages with commercial bedding (San-i-cel, Paxton Processing Company, Inc., Paxton, IL, USA)
- Food: ad libitum, commercial diet (Wayne, Allied Mills, Chicago, IL, U.S.A.)
- Water: ad libitum - Route of administration:
- dermal
- Vehicle:
- acetone
- Details on exposure:
- 0.20 ml of chemical was applied to the shaved dorsal skin of the flanks in a 1-inch square area on mice (25 g). The 100% dose represents 752 mg/kg bw. Given twice weekly (once every 3.5 days), the dose is approximately 215 mg/kg/d).
- Analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- Twice per week
- Remarks:
- Doses / Concentrations:
10, 50 and 100%
Basis:
nominal conc.
in acetone. - No. of animals per sex per dose:
- 50 per dose group in the treatment group. 50 animals served as vehicle control and positive control. 135 untreated animals also served as controls.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The animals were checked weekly and all lesions and tumours were recorded. Animals were allowed to die spontaneously or were killed when moribund.
- Positive control:
- Yes, 7,12-dimethylbenzanthracene
- Observations and examinations performed and frequency:
- Animals were observed twice weekly.
- Sacrifice and pathology:
- Complete autopsies were performed on all animals. Histological examination was undertaken on the treated skin from all animals, all grossly observed tumors and other lesions in the lungs, livers, kidneys, etc. of treated and control animals. Formalin-fixed, paraffin-embedded specimens were cut and stained with hemotoxylin-eosin and other stains when needed.
- Statistics:
- The statistical significance of results was evaluated using the methods of Armitage, 1971.
- Details on results:
- In the skin, a slight local inflammatory change was noted. The lifespan of the EHD-treated mice did not differ significantly from that of the controls. Tumour incidences were not elevated over that of the vehicle controls.
- Relevance of carcinogenic effects / potential:
- Relevant for dermal low-dose applications or exposures.
- Dose descriptor:
- other: tumour incidence
- Effect level:
- 215 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No differences from vehicle controls, but slightly increased over untreated controls.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- In a dermal carcinogenicity study with Swiss mice involving applications twice weekly for a lifetime, EHD did not produce a statistically-significant increase in cutaneous tumour incidence compared with untreated and positive control animals. In combination with mutagenicity data, the substance is not considered a genotoxic carcinogen.
Reference
The tumour incidence (%) for 2 -ethyl-1,3 -hexanediol (EHD), at 46 -64%, was increased above the untreated controls (42%), but
not over vehicle controls.
The incidence of tumors over untreated controls was not site-specific. The authors conclude that EHD did not produce a statistically-significant increase in cutaneous tumour incidence compared with untreated and positive control animals.Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 215 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- adequate, when genotoxicity is included.
Justification for classification or non-classification
The data do not meet the criteria for classification according to Regulation EC No. 1272/2008.
Additional information
In this study, the tumour incidence (%) in the highest dose of EHD, was slightly increased above the untreated controls, but
not over vehicle controls. The incidence of tumors over untreated controls was not site-specific.
The authors conclude that EHD did not produce a statistically-significant increase in cutaneous tumour incidence compared with untreated and positive control animals. Analysis by the U.S. EPA in 1981 found a positivelinear trend, and a site-specific chi-squared test indicated a possible oncogenic potential for EHD. However, they determined
the study to be inadequate for the purposes of determining the carcinogenic potential of EHD.
Justification for selection of carcinogenicity via dermal route endpoint:
experimental result
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