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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 223-032-9 | CAS number: 3699-54-5
- 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
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The substance was assessed in a combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD guideline 422 and under GLP) in rats (Rohm and Haas, 2002).
The substance was administered daily to rats by gavage at doses of 0, 100, 300 or 1000 mg/kg bw/day. Exposure of parental animals (12/sex/dose) began when the animals were approximately eleven weeks of age. Parental animals were mated after two weeks of exposure. Treatment continued throughout gestation, lactation, and until terminal necropsy.
Body weight, feed consumption, and clinical signs were monitored in parental animals throughout treatment. Animals were examined weekly using Detailed Clinical Observations (DCO). During Week 5 (males) and Week 7 (females), animals were assessed using a Functional Observational Battery (FOB) and monitored for motor activity (MA). Parental animals were euthanized and necropsied after weaning of their litters. Blood samples were collected for hematology and clinical chemistry analysis from all adult rats at terminal necropsy. Selected organs were weighed, and tissues were collected for histopathologic evaluation. Histopathologic evaluation was performed on five randomly selected animals/sex in the control and high dose group, and in a female (Group 3, 300 mg/kg bw/day) euthanized for humane reasons during the course of the study.
On Postnatal Day 0 (PND0), all offspring were examined externally, and their status (e.g., alive, dead, stillborn, or uncertain), sex, and weight were determined. On PND4, pups were again counted, sexed, weighed, and examined for gross abnormalities prior to being euthanized. Pups were discarded without further evaluation.
There were no treatment-related deaths or clinical signs of systemic toxicity in females during premating, females during gestation, females and pups during lactation, or in males throughout the study at any dose level. There were no treatment-related effects on body weight or feed consumption in females during the premating, gestation or lactation periods or in males throughout the study.
There were no treatment-related effects on any endpoint of mating or fertility at any dose.
There were no treatment-related effects on gestation index, gestation length, or number of pups per litter. There were no treatment-related deaths during delivery, and there were no litters entirely stillborn. There were no treatment-related effects on the mean number of implantation sites or post-implantation loss at any dose level. There were no treatment-related effects on offspring viability or the ratio of male to female pups.
There were no treatment-related effects on offspring body weight at any dose. There were no external abnormalities noted at any dose level. No treatment-related effects were seen in the Detailed Clinical Observations or Functional Observational Battery parameters. There were no treatment-related effects noted in motor activity in either sex at doses up to and including 1000 mg/kg bw/day. There were no treatment-related changes in any hematology or clinical chemistry parameters in either sex at any dose level.
No treatment-related changes in organ weights were noted in either sex at any dose level.
No treatment-related gross or microscopic pathological findings were observed in either sex at any dose level.
The substance, when administered to rats daily via gavage for approximately 8 weeks at doses of 0, 100, 300, or 1000 mg/kg bw/day, had a NOAEL for parental animal toxicity of 1000 mg/kg bw/day. The reproductive and developmental NOAEL was 1000 mg/kg bw/day.
Short description of key information:
In a combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test via gavage in rats a NOAEL of 1000 mg/kg bw/day for parental toxicity was observed. The reproductive and developmental NOAEL was 1000 mg /kg bw/day. No adverse effects were observed at the dose levels tested.
Effects on developmental toxicity
Description of key information
In a combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test via gavage in rats a NOAEL of 1000 mg/kg bw/day for parental toxicity was observed. The reproductive and developmental NOAEL was 1000 mg /kg bw/day. No adverse effects were observed at the dose levels tested.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The substance was assessed in a combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test (according to OECD guideline 422 and under GLP) in rats (Rohm and Haas, 2002).
The substance was administered daily to rats by gavage at doses of 0, 100, 300 or 1000 mg/kg bw/day. Exposure of parental animals (12/sex/dose) began when the animals were approximately eleven weeks of age. Parental animals were mated after two weeks of exposure. Treatment continued throughout gestation, lactation, and until terminal necropsy.
Body weight, feed consumption, and clinical signs were monitored in parental animals throughout treatment. Animals were examined weekly using Detailed Clinical Observations (DCO). During Week 5 (males) and Week 7 (females), animals were assessed using a Functional Observational Battery (FOB) and monitored for motor activity (MA). Parental animals were euthanized and necropsied after weaning of their litters. Blood samples were collected for hematology and clinical chemistry analysis from all adult rats at terminal necropsy. Selected organs were weighed, and tissues were collected for histopathologic evaluation. Histopathologic evaluation was performed on five randomly selected animals/sex in the control and high dose group, and in a female (Group 3, 300 mg/kg bw/day) euthanized for humane reasons during the course of the study.
On Postnatal Day 0 (PND0), all offspring were examined externally, and their status (e.g., alive, dead, stillborn, or uncertain), sex, and weight were determined. On PND4, pups were again counted, sexed, weighed, and examined for gross abnormalities prior to being euthanized. Pups were discarded without further evaluation.
There were no treatment-related deaths or clinical signs of systemic toxicity in females during premating, females during gestation, females and pups during lactation, or in males throughout the study at any dose level. There were no treatment-related effects on body weight or feed consumption in females during the premating, gestation or lactation periods or in males throughout the study.
There were no treatment-related effects on any endpoint of mating or fertility at any dose.
There were no treatment-related effects on gestation index, gestation length, or number of pups per litter. There were no treatment-related deaths during delivery, and there were no litters entirely stillborn. There were no treatment-related effects on the mean number of implantation sites or post-implantation loss at any dose level. There were no treatment-related effects on offspring viability or the ratio of male to female pups.
There were no treatment-related effects on offspring body weight at any dose. There were no external abnormalities noted at any dose level. No treatment-related effects were seen in the Detailed Clinical Observations or Functional Observational Battery parameters. There were no treatment-related effects noted in motor activity in either sex at doses up to and including 1000 mg/kg bw/day. There were no treatment-related changes in any hematology or clinical chemistry parameters in either sex at any dose level.
No treatment-related changes in organ weights were noted in either sex at any dose level.
No treatment-related gross or microscopic pathological findings were observed in either sex at any dose level.
The substance, when administered to rats daily via gavage for approximately 8 weeks at doses of 0, 100, 300, or 1000 mg/kg bw/day, had a NOAEL for parental animal toxicity of 1000 mg/kg bw/day. The reproductive and developmental NOAEL was 1000 mg/kg bw/day.
Justification for classification or non-classification
Based on the available study, 1-(2-hydroxyethyl) imidazolidin-2-one does not need to be classified for reproduction toxicity according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) 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.
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.