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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- EC Number:
- 223-032-9
- EC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Cas Number:
- 3699-54-5
- Molecular formula:
- C5H10N2O2
- IUPAC Name:
- 1-(2-hydroxyethyl)imidazolidin-2-one
- Details on test material:
- - Name of test material: N-(2-hydroxyethyl)imidazolidin-2-one, HOXI
- Lot/batch No.: 0029411150002
- Physical state: white crystalline solid
- Analytical purity: 98.6 ± 0.4% m/m. approx 15 organic byproducts, each ≤ 0.3% m/m
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: Approx. 6 weeks
- Weight at study initiation: 354 - 479 grams
- Housing: Group housing af 2 animals, except for 1 control animal, per labelled metal cage with wire-mesh flaors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-8, pellet diameter 4 mm (Hope farms, Woerden, The Netherlands).
- Water (e.g. ad libitum): Free access to tap water, diluted with decalcified water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- induction:
intradermal injection: 25%
epidermal application: 50%
challenge:
epidermal application: 50%, 25% and 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction:
intradermal injection: 25%
epidermal application: 50%
challenge:
epidermal application: 50%, 25% and 10%
- No. of animals per dose:
- 10 (treatment group), 5 (control group)
- Details on study design:
- INDUCTION - EXPERIMENTAL ANIMALS
Day 1: Three pairs of intradermal injections (0.1 ml/site) were made in the clipped scapular region as follows:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water for injection (Ferensius AG, Bad Homburg, Germany).
B) The test substance at a 25% concentration.
C) The test substance, at twice the concentration used in (B), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
Note: One of each pair was on each side of the midline and from cranial A) to caudal C).
Day 3: The dermal reactions caused by the intradermal injections were recorded.
Day 7: The clipped scapular area was rubbed with 10% sodium-dodecyl-sulfate (SOS, Boom, Meppel, The Netherlands) in vaseline using a spatula. This concentration of SOS provokes a mild inflammatory reaction.
Day 8: The c1ipped area between the injection sites was treated with 0.5 ml of a 50% test substance concentration using a Scotchpak-non-woven patch (2 x 4 cm) mounted on Micropore tape and secured with Coban elastic bandage.
Day 10: After 48 hours, the dressings were removed and the skin cleaned of residual test substance. Subsequently, all dermal reactions caused by the epidermal exposure were recorded, according the scale presented before.
INDUCTION - CONTROL ANIMALS
Day 1: Intradermal injections were made similar to the method described above with the omission of the test substance.
Day 3: The dermal reactions caused by the intradermal injections were recorded.
Day 7: SOS 10% treatment, as described above.
Day 8: Epidermal treatment as described far the experimental animals, but with the vehicle only.
Day 10: After 48 hours, the dressings were removed and the skin cleaned. Subsequently, all dermal reactions caused by the epidermal exposure were recorded.
CHALLENGE
Day 22: All animals were treated epidermally with 0.05 ml of each of a the following test substance concentrations, 50%, 25% and 10% and the vehicle on a clipped flank, using Square chambers, attached to Micropore tape and secured with Coban elastic bandage.
Day 23: After approximate1y 24 hours, the dressings were removed and the skin cleaned of residual test substance and vehicle. The treated sites were assessed for erythema and swelling 24 and 48 hours after removal of the dressings, using the numerical grading system be1ow. After the first reading, the test sites were clipped with an electric clipper. - Challenge controls:
- No
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Induction phase
Since comparable reactians were noted in the experimental and contral animals after the epidermal induction exposure, the reactions were considered to be enhanced by the SOS treatment.
Challenge phase
No skin reactions were evident after the challenge exposure in the experimental and control animals.
No evidence was obtained that the substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result leads to a sensitisation rate of 0 per cent.
Toxicity Symptoms / Mortality
One experimental animal showed hyperpnoea and dark red coloured eyes on day 19. This animal was removed from the study and killed in extremis later that day. An enlarged spleen and dark red lungs were found at necropsy. These findings indicate acute pneumonia. Since no further mortality occurred and no symptoms of systemic toxicity were observed during the study period, it was considered that the study outcome, based on the surviving animals, was not adversely affected.
Body Weights
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Applicant's summary and conclusion
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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