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EC number: 271-603-6 | CAS number: 68586-02-7
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products. - Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no vehecle
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 500 ppm
- Dose / conc.:
- 1 500 ppm
- Dose / conc.:
- 5 000 ppm
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 5 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Critical effects observed:
- no
- Conclusions:
- Repeated exposure to propan-2-ol produced toxic effects only at 5000 ppm (12300mg/m3)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 417 mg/m³
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products. - Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: no vehecle
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 500 ppm
- Dose / conc.:
- 1 500 ppm
- Dose / conc.:
- 5 000 ppm
- Dose descriptor:
- NOAEC
- Effect level:
- ca. 5 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- Critical effects observed:
- no
- Conclusions:
- Repeated exposure to propan-2-ol produced toxic effects only at 5000 ppm (12300mg/m3)
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, the hydrolysis rate is estimated to be within 30 minutes. The hydrolysis products have been identified to be ethanol, 2-propanol, acetylacetone and titanium dioxide.
The properties of the target substance would lie in the hydrolysis products. - Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.28 (Sub-Chronic Dermal Toxicity Test: 90-Day Repeated Dermal Dose Study Using Rodent Species)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- mouse
- Strain:
- C3H
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The animals were housed individually in suspended stainless-steel wire cages in a room with controlled lighting. Certified diet (Agway, Ithaca, USA) and water from an automatic watering system were provided ad lib.
- Type of coverage:
- open
- Vehicle:
- acetone
- Details on exposure:
- Test substances were applied using an Eppendorf automatic pipette, 50μl per application, to the back of each mouse from which the fur was clipped once weekly. The tip of the pipette was used to spread the test substance from the interscapular area to the lumbar area of each mouse.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 3 times a week for 13 weeks
- Dose / conc.:
- 140 mg/kg bw/day (nominal)
- Remarks:
- male
- Dose / conc.:
- 460 mg/kg bw/day (nominal)
- Remarks:
- male
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- male
- Dose / conc.:
- 160 mg/kg bw/day (nominal)
- Remarks:
- female
- Dose / conc.:
- 540 mg/kg bw/day (nominal)
- Remarks:
- female
- Dose / conc.:
- 2 300 mg/kg bw/day (nominal)
- Remarks:
- female
- No. of animals per sex per dose:
- 15
- Control animals:
- no
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of toxicity or skin irritation were observed during the study.
- Dermal irritation:
- no effects observed
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- A vehicle control male, a high-dose male and a low-dose femal died during the study.
These deaths were considered unrelated to TEA treatment. - Body weight and weight changes:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- Key result
- Critical effects observed:
- no
- Conclusions:
- When TEA was applied to the skin of mice 3 times per week for 95 days, mild epidermal hyperplasia was observed without evidence of systemic toxicity.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 244 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No studies were conducted on the target substance. As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. The hydrolysis products include ethanol, 2-propanol and pentane-2,4-dione, and non-hazardous titanium dioxide. This information is used as a supporting evidence on the toxicity of the target substance in CSA. Among the 3 organic hydrolysis products, the most hazardous compound – pentane-2,4-dione was considered.
Oral studies
There is one study available for repeated oral toxicity, carried out on rats (strains not specified). The reported NOAEL was 100 mg/kg/bw/d. In this study test animals were given by gavage 0, 100, 500 and 1,000 mg/kg bw of test substance. Test substance was administered for 1 -15 days in 1-11 applications. In the highest dose group all animals died within 1 hour after dosing. In the 500 mg/kg bw group 3/5 animals died and 2/5 were sacrificed due to poor condition after four applications. Various substance related systemic effects were observable in this dose group such as distended bladder, congested lungs, clouding of cornea, thymic necrosis, hepatocyte swelling and congestion, nephrosis, lymphadenitis of mesenteric lymph nodes and inflammation of the heart. In the lowest dose group (100 mg/kg bw) no histopathological or gross pathological changes and no differences in weight gain, organ weights, hematology, clinical chemistry or clinical signs were evident.
(Eastman Kodak 1979, cited in UNEP SIDS, Pentane-2,4-dione)
Dermal studies
NOAEL and LOAEL were 244 mg/kg bw/d and 975 mg/kg bw/d according to systemic effects observed.
(Ballantyne 2001, cited inUNEP SIDS, Pentane-2,4-dione)
Inhalation studies
NOAEL and LOAEL were 100 ppm (417 mg/m3) and 650 ppm (2711 mg/m3), respectively, determined in a 14 week inhalation study, conducted on 20 male and 20 female Fischer 344 rats. The test animals were exposed to 0, 100, 300 and 650 ppm (nominal conc., corresponding to 0, 417, 1217 and 2711 mg/m3) of pentane-2,4-dione vapor for 6 hour/day, 5 day/week. On histopathology, no substance related gross lesions were detectable in the organs examined in all dose groups with the exception of different regions in the brain where hemorrhage and neuronal degeneration was observable at a dose of 650 ppm.
In the 100 ppm group there were no substance related mortalities in either sex and on comparison with untreated controls no differences in clinical and urinary chemistry, hematology or after histopathological examination were detectable.
(Dodd et al. 1986, cited in UNEP SIDS, Pentane-2,4-dione)
Justification for classification or non-classification
Based on the NOAEL
(oral), NOAEC (inhalation) and NOAEL (dermal) of pentane-2,4-dione,
there is no need for classification of the target substance in
accordance with the criteria of CLP Regulation.
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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