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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04.02.2002 - 19.02.2002
- 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 405 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Extertal, Germany
- Age at study initiation: approx. 11 weeks
- Weight at study initiation: 1987.4 g, 2020.9 g and 2062.7 g
- Housing: Single housed 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. A non-barrier system with air was used.
- Diet: ad libitum, Supplier: Altromin International, Lage, Germany; Type: 2023; Batch No. 0733
- Water: ad libitum normal tap water from municipal sources
- Acclimation period: The animals were used for a skin irritation test before, where the test substance was classified as non-irritating. The animals were observed for their health condition, therefore it was assured that the animals were in good condition for this investigation and no acclimation period was needed.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 8 times/hour
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g of the test substance was applied into the right eye by pulling the lower eyelid away from the eyeball to form a cup.
- Observation period (in vivo):
- Examination of the treated eyes was made 1 hour and approximately 24, 48, 72 hours and 7 days after the application of the test substance.
- Number of animals or in vitro replicates:
- One male and two females were used.
- Details on study design:
- See "any other information on material and methods"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity 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:
- cornea opacity 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:
- cornea opacity 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:
- iris 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:
- iris 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:
- iris 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:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Rabbit 502
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Rabbit 501
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Rabbit 503
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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
- Other effects:
- Systemic toxic symptoms caused by the test substance were not observed during the whole study.
Body weight gain was positive and within normal range.
Any other information on results incl. tables
The Primary Irritation Index was used to classify the test substance as follows:
0 -11: non-irritant
12 - 25: midly irritating
26 - 56: moderately irritant
57 - 110: severe irritant
The Primary Irritation Idex for Creatinine was calculated to be 4 if the maximum value after one hour exposure was chosen for calculation.
Ocular Lesions:
Slight redness of the conjunctivea (injectionn of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on. The numerical scores awarded to the ocular reactions elicited by the test substance are presented in the following table:
|
Rabbit 501(female) |
Rabbit 503 (female) |
Rabbit 502 (male) |
|||||||||||||
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
||
Cornea |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
A |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae
|
A |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
B |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
C |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Individual body weights:
Body weight gain was positive and within normal range. The data is given in the following table:
Rabbit number and sex |
Weight at day 0 [g] |
Weight at day 7 [g] |
501 (female) |
2020.9 |
2147.0 |
503 (female) |
1987.4 |
2157.5 |
502 (male) |
2062.7 |
2155.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the substance Creatinine could be classified as non-irritant to the eyes
- Executive summary:
The substance Creatinine was tested regarding to its irritation potential towards eyes and adjacent muscous membranes of experimental animals according to OECD Guideline No. 405 ("Acute Eye Irritation/Corrosion").
The potential to cause damage to the conjunctiva, iris and corea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of two male and one female rabbit, strain New Zealand White. 0.1 g of the test substance was applied. Ocular reactions were assessed 1, 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.
Slight redness of the conjunctivae (injection of the blood vessels) was observed in all animals one hour after application of the test substance and slight chemosis was observed in two animals one hour after application. Only one animal showed a slight redness of the conjunctivae 24 hours after application. The eyes of all three rabbits were normal from the 24 hour examination on.
Under the conditions of this study the test substance Creatinine was classified as non-irritant to the eyes.
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