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EC number: 200-466-7 | CAS number: 60-27-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.01.2002 - 12.02.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-imino-1-methylimidazolidin-4-one
- EC Number:
- 200-466-7
- EC Name:
- 2-imino-1-methylimidazolidin-4-one
- Cas Number:
- 60-27-5
- Molecular formula:
- C4H7N3O
- IUPAC Name:
- 2-imino-1-methylimidazolidin-4-one
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Creatinin
- Physical state: solid
- Expiration date of the lot/batch: 28.01.2004
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 1869, 1818, 1832 g
- Housing: Housed single (male) or with two animals (female) single in steel cages with a plastic bottom mould and a habitat of 5445 square centimeters at the bottom and an overall height of 600 millimeters.
- Diet (e.g. ad libitum): The animals received food "2123" from Altromin International, Lage, Germany as pelleted diet. The food was offered ad libitum.
- Water (e.g. ad libitum): Normal tap water from municipal sources (Stätische Werke Krefeld AG, Abt. 2 TGW, 47804 Krefeld, Germany) was supplied to the animals ad libitum via bottels with rubber stoppers and steel pipes.
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (17-23 °C)
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- To ensure that the test substance gets in close contact to the skin 0.5 g of the test substance was moistened with 0.5 mL saline solution.
- Duration of treatment / exposure:
- The test substance was removed after 4 hours exposure time.
- Observation period:
- Examination of the treated skin sites was made 1 hour, 4 hours and approximately 24, 48, 72 hours and 7 days after application of the test substance.
- Number of animals:
- one male and two females
- Details on study design:
- - 24 hours before dosing a part of the fur on both sides of the dorso-lumbal region of each animal was removed by shearing with an electrical shaving machine exposing an area of skin approximately 10 x 15 cm. Care was taken to avoid abrading the skin and only animals with healthy skin were used in the experiment
- test substance was applied to the front region of both test sites on a gauze pad (3x2 cm) each and held in place by strips of Blenderm (3 M company, St. Paul, USA). The back region behind the gauze was used as control region.
Scoring System:
see "any other information on materials and methods incl. tables"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 3 min, 1 h, 4 h, 24 h, 48 h, 72 h and 7 d
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No erythema and oedema and no other dermal response were observed at any time point. The numerical scores to the erythema and oedema formations are presented in table 1 under "any other information on results incl. tables"
The Primary Irritation Index was calculated to be "0" scores of maximum "8" possible scores. - Other effects:
- Systmemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within the normal range.
Any other information on results incl. tables
Table 1: Numerical scores to the erythema and oedema formations.
|
Rabbit 1 (Female) |
Rabbit 2 (Female) |
Rabbit 3 (Male) |
||||||||||||||||||
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
3 min |
1 h |
4 h |
24 h |
48 h |
72 h |
7 d |
|
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.
- Executive summary:
Creatinine was tested regarding its irritation potential towards the skin according to OECD 404 ("Acute Dermal Irritation/Corrosion"). The potential to cause inflammatory or corrosive changes upon first contact with skin was assessed by occluded application of the test substance for four hours to the shorn skin of two male and one female rabbit, strain New Zealand White. Dermal reactions were assessed 1, 4, 24, 48, 72 hours and 7 days after removal of the test substance.
Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. No erythema and oedema and no other dermal response were observed at any time point. The Primary Irritation Index was calculated to be "0" from "8" possible scores.
Under the conditions of this study the test substance Creatinine was classified as "non-irritant" to skin.
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