Registration Dossier
Registration Dossier
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: 223-496-2 | CAS number: 3923-79-3
- 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
In an in vivo study according to OECD guideline 404, the undiluted test substance was applicated for 4 hours under semiocclusive conditions to the skin of New Zealand White rabbits. Results did not give indication of an irritant property to the skin under the test conditions chosen and considering the described findings.
In a supporting in vivo rabbit study, the test item was not irritating to to skin after 24-hour occlusive treatment to intact skin.
In a key eye irritation study according to OECD 405, the test substance was injected into the eyes of New Zealand White rabbits. Results did not give indication of an irritant property after 24 hours of treatment.
In a supporting in vivo eye irritation study in rabbits, the test substance was not irritating to the eyes after injection and 24-hour treatment.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Young adult animals were used. They were identified via ear tattooing. The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20-24°C for temperature and of 30 - 70% for relative humidity. The day/night rhythm was 12 h dark and 12 h light. The animals were housed singly in stainless steel wire mesh carges with grating (floor area: 3000 cm2) with no bedding in the cages (sawdust in the waste trays). A standard diet was used (about 130 g per animal/day) and about 250 ml tap water per animal and per day were available.
Weight of female animals: 3.66 and 3.65 kg
Weight of the male animal: 3.45 kg - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipping the dorsal of the trunk of the animal(s)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- Acclimatization period for at least 1 week. Weight determination before application of the test substance.
The test substance was applied in a single dose to the intact untreated skin, the test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol and Lutrol / water (1:1). The test patch (2.5 x 2.5 cm) was moistened with a dose of 0.5 ml of the unchanged liquid test substance. Application site: the upper third of the back or flanks.
Readings: 1 h, 24 h, 48 h and 72 h after removal of the patch.
A check was made twice each workday and once on weekends and on public holidays for general observations and for any dead or moribund animals. - Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Conclusions:
- Under the test conditions chosen and considering the described findings, the test substance does not give indication of an irritant property to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Key, in vivo skin irritation, RL2
BASF (1995) reported about the acute dermal irritation/corrosion of 4,5-Dihydroxy-1,3-dimethylimidazolidin-2-one. New Zealand White rabbits were applicated 0.5 mL of the undiluted test substance for 4 hours under semiocclusive conditions. Under the test conditions of this study, the test substance does not give an indication of an irritant property to the skin.
Supporting, in vivo skin irritation, RL2
Hill Top (1979) reported a skin irritation study with Textile Resin NFU (= 4,5-Dihydroxy-1,3-dimethylimidazolidin-2-one). New Zealand White rabbits were applicated (intact and abraded skin) 50 mL of the indiluted test substance for 24 hours under occlusive conditions. No skin reactions were found.
Key, in vivo eye irritation, RL2
BASF (1995) reported an acute eye irritation study. 0.1 mL of the unchanged test substance were injected into the eyes of New Zealand White rabbits. Duration of treatment was 24 hours. Under the test conditions of this experiment, the test substance does not give an indication of an irritant property.
Supporting, in vivo eye irritation, RL2
The Springborn Institute (1980) tested 4,5 -Dihydroxy-1,3-dimethylimidazolidin-2-one concerning eye irritation. 0.1 mL of the undiluted test substance were injected into the eyes of New Zealand White rabbits. Duration of treatment was 24 hours. The test material was considered as non-irritant.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data, the test item is not classified and labelled for skin irritation according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.