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Diss Factsheets
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EC number: 245-524-2 | CAS number: 23251-72-1
- 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
No data are available on DEA acetate. However, a one-generation reproductive toxicity study has been conducted on RA2. This yielded a critical NOAEL of 300 mg/kg bw/day based on an increased number of dead pups and post-implantation losses in females ("possibly test item-related") at 1000 mg/kg bw/day (a paternally, but not maternally, toxic dose).
Link to relevant study records
- Endpoint:
- toxicity to reproduction
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Although no relevant data are available on DEA acetate, a good-quality, reliable, GLP-compliant, OECD-guideline one-generation study on RA2 is available (Becker & Ceccatelli, 2007; Becker et al. 2008). Together with exposure-based data waivers, this meets the REACH tonnage-driven data requirements.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
REACH Annex XI states that testing for reproductive toxicity in accordance with Annex VIII may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. A low likelihood of human exposure is anticipated, and a log Pow expected to be lower than -1.31 indicated that bioaccumulation is not likely to occur. In addition, no adverse effects were seen on the reproductive organs of the parental animals or on fertility in a reliable oral one-generation reproductive toxicity study on a structurally-related read-across compound, resulting in a fertility NOAEL of 1000 mg/kg bw/day (Becker & Ceccatelli, 2007; Becker et al. 2008). No treatment-related adverse effects on the reproductive organs (including testes, epididymis, seminal vesicles, uterus, ovaries and vagina) was seen in rats administered RA1 at up to 750 mg/kg bw/day (Braun, 2000) or RA2 at up to 1000 mg/kg bw/day (Allard and Becker, 1997) by gavage for 28 days.
Short description of key information:
No data are available on DEA acetate, but a reliable one-generation reproduction toxicity test using read-across substance RA2 was used to address this point. No effects on fertility, or on the reproductive organs, were seen in this study at up to 1000 mg/kg bw/day (considered the fertility NOAEL). In addition, no treatment-related adverse effects on the reproductive organs was seen in rats administered RA1 at up to 750 mg/kg bw/day (Braun, 2000) or RA2 at up to 1000 mg/kg bw/day (Allard and Becker, 1997) by gavage for 28 days.
Justification for selection of Effect on fertility via oral route:
Data waiver based on a GLP, OECD guideline one-generation study (reliability 2) on a related compound, and on the basis of a low likelihood of human exposure
Effects on developmental toxicity
Description of key information
No data are available on DEA acetate, but a one-generation reproduction toxicity test, using read-across substance RA2, was used to address this endpoint.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Species:
- rat
- Quality of whole database:
- Although no relevant data are available on DEA acetate, a good-quality, reliable, GLP-compliant, OECD-guideline one-generation study on RA2 is available (Becker & Ceccatelli, 2007; Becker et al. 2008). Together with exposure-based data waivers, this meets the REACH tonnage-driven data requirements.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
REACH Annex XI states that testing for developmental toxicity in accordance with Annex VIII may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. A low likelihood of human exposure is anticipated, and a log Pow expected to be lower than -1.31 indicated that bioaccumulation is not likely to occur. In addition, no teratogenic effects were seen in a reliable oral one-generation reproductive toxicity study on a structurally-related read-across compound at up to 1000 mg/kg bw/day. However, at this top dose, an increased number of dead pups and post-implantation losses ("possibly test item-related") was observed, resulting in a developmental toxicity NOAEL of 300 mg/kg bw/day (Becker & Ceccatelli, 2007; Becker et al. 2008).
Justification for selection of Effect on developmental toxicity: via oral route:
Data waiver based on a GLP, OECD guideline one-generation study (reliability 2) on a related compound, and on the basis of a low likelihood of human exposure
Toxicity to reproduction: other studies
Additional information
No data are available on DEA acetate, but a reliable one-generation reproduction study has been conducted on the structurally-related read-across compound, RA2.
Wistar rats (24/sex/dose) were orally given RA2 at up to 1000 mg/kg bw/day. RA2 was administered to males for 70 days before pairing, until the last litter had reached day 4 postpartum. Females were treated for 14 days prior to pairing, then throughout pairing, gestation and lactation.
No effects on fertility or maternal toxicity were seen at any dose. The critical NOAEL was established at 300 mg/kg bw/day, based on reductions in food consumption, body weight gain and liver body weight ratio in paternal males, and increased number of dead pups and post-implantation loss in females ("possibly test item-related") at 1000 mg/kg bw/day. In addition, no teratogenic effects were seen in the offspring (Becker & Ceccatelli, 2007; Becker et al. 2008).
Justification for classification or non-classification
No relevant data are available on DEA acetate, but a one-generation reproductive toxicity study on the structurally-related compound RA2 found increased numbers of dead pups, and possibly treatment-related increases in post implantation loss in females given 1000 mg/kg bw/day, in the absence of maternal toxicity. As such, a critical NOAEL of 300 mg/kg bw/day was reported. No teratogenicity or effects on fertility were observed. As such, there is no evidence to indicate that DEA acetate requires classification, according to Regulation (EC) No. 1272/2008.
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.
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