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Diss Factsheets
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EC number: 243-001-3 | CAS number: 19372-44-2
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
There is no study available of the type "screening for reproductive / developmental toxicity" which is an information requirement for the tonnage band 10-100 t/year (REACH, Annex VIII) and also for 100-1000 t/year (REACH, Annex IX). However, according to REACH Annex VIII, 8.7.1, Column 2, such information does not need to be provided if a pre-natal developmental is available.
Such pre-natal developmental toxicity data has been provided in the dossier (see under "Effects on developmental toxicity" and under "7.8.2 Developmental toxicity / teratogenicity" of the IUCLID data set). The data is on the read-across substance 2,4 -pentanedione (CAS No 123 -54 -6) and a thorough justification for this read-across approach is provided in IUCLID section 13.
Furthermore is pointed out concerning information requirements:
According to Reach Regulation Annex IX column 1, 8.7.3, a two generation test for the endpoint reproductive toxicity should be performed if effects on the reproductive organs were observed in subacute or subchronic tests. For the read-across substance 2,4-Pentanedione no statistically significant adverse effects on reproductive organs were observed after repeated exposure. In a subchronic inhalation toxicity study (5 d/week, 6 h/d) with acetylacetone conducted in male and female F344 rats with exposure concentrations of 0, 100, 300 and 650 ppm key reproductive organs (testes, epididymis, uterus, cervix and ovaries) were examined. Changes to reproductive organs were observed in individual animals but without statistical significance and biological relevance when compared to control animals. One animal of the control and one of the 300 ppm group had non-significant changes in the uterus size. One animal of the 300 ppm dose group had non-significant size changes in the cervix. After 4-week recovery phase one control animal showed epididymitis while in two females of the control group ovarial cysts were found. As none of these effects is of biological relevance it is concluded that after study termination and also after the four week recovery period no adverse effects on male and female reproductive organs were found.
In conclusion no adverse effects on reproductive organs are expected for the read-across substance 2,4-Pentanedione based on the available subacute and subchronic data on 2,4-Pentanedione. In accordance with REACH Regulation Annex IX column 1, 8.7.3, it is therefore not necessary to provide data from a two generation test (OECD 416) or an extended one generations test (OECD 443) as a surrogate.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Information and comment given by the previous lead registrant:
No developmental study is available on the registered substance. There is an inhalation developmental study on the read-across substance, 2,4 -pentanedione CAS# 123 -54 -6. However the source of the data is from a published literature article with only limited information (see endpoint study record). However the effects reported do not appear to be sufficient for classification. Fetotoxic effects (reduced fetal weights in male fetuses) were observed at 200 ppm without signs of maternal toxicity. In addition, at 400 ppm (reduced fetal weights in fetuses of both sexes and reduced fetal ossification) reduced maternal weight also occurs.
Comment of the present lead registrant to these statements:
The present lead registrant agrees to the above given statements except for these points:
The published literature article is regarded as a meaningful source of information. It contains all essential information from the conducted study.
Furthermore, to be precise on concentrations: Fetotoxic effects (reduced fetal weights in male fetuses) were observed at 202 ppm without signs of maternal toxicity. In addition, at 398 ppm (reduced fetal weights in fetuses of both sexes and reduced fetal ossification) reduced maternal weight also occurs.
The lowest NOAEC (with no effect on fetal weights) can thus be determined as 217 mg/m3 (information in literature article of Tyl et al 1990: 53 ppm of 2,4-pentanedione).
The NOAEC for maternal animals can be pointed out as 827 mg/m3 (Tyl et al.1990, p 470: for maternal animals, very slight, nonstatistically significant, reduction in body weights at 202 ppm).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 217 mg/m³
- Species:
- rat
- Quality of whole database:
- Equivalent or similar to OECD Guideline 414 Prenatal Developmental Toxicity Study. Fetal weight is basis for NOAEC.
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data C&L for this endpoint is not warranted. The results are regarded as conclusive but not sufficient for classification.
Additional information
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.