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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14.02.2002 - 30.04.2002
- 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 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A guideline for the LLNA was not available when the study was performed.
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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pribright White, BOR DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- In contrast to the title of the study guinea pigs were used instead of rabbits. This is an error in the study report.
TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: approx. 6 weeks
- Weight at study initiation: 294.1 - 354.1 g
- Housing: housed with 2 or 3 animals in Makrolon-cages No.4. A non-barrier system with air conditioning was used
- Diet (e.g. ad libitum): The animals received food "3022" from Altromin International, Lage, Germany as pelleted diet, offered ad libitum
- Water (e.g. ad libitum): normal tap water fro, municipal sources ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (17 - 23 °C)
- Humidity (%): 30 -70 %;
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): Lighting was in a 12-hour-light/dark-cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: saline solution
- Concentration / amount:
- Pilot experiment
Intradermal: 0.1 mL of 5 %, 3.5 %, 2 % and 0.5 % (w/w) solution in saline
Dermal: 0.5 g 50 % (w/w) saline suspension and 0.5 g of the test substance moistened with 0.5 mL saline solution
Challenge: Duhring chamber with 20 %, 40 %, 50 % (w/w) saline suspension and the moistened test substance
Main experiment
Intradermal: 0.1 mL of 5 % (w/w) solution in saline
Dermal: 0.5 g of the test substance moistened with 0.5 mL saline solution
Challenge: Duhring chamber with 20 % (w/w) saline suspension
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: saline solution
- Concentration / amount:
- Pilot experiment
Intradermal: 0.1 mL of 5 %, 3.5 %, 2 % and 0.5 % (w/w) solution in saline
Dermal: 0.5 g 50 % (w/w) saline suspension and 0.5 g of the test substance moistened with 0.5 mL saline solution
Challenge: Duhring chamber with 20 %, 40 %, 50 % (w/w) saline suspension and the moistened test substance
Main experiment
Intradermal: 0.1 mL of 5 % (w/w) solution in saline
Dermal: 0.5 g of the test substance moistened with 0.5 mL saline solution
Challenge: Duhring chamber with 20 % (w/w) saline suspension
- No. of animals per dose:
- 10 females in main experiment
- Details on study design:
- see "any other information on material and method"
- Challenge controls:
- see "any other information on material and method"
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- Sensitation rate of 60 %
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2-mercaptobenzothiazole 5 %
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Symptoms:
Toxic symptoms caused by the test substance were not observed during the whole study.
Body Weight:
Body weight development was positive and within normal range.
Pilot Experiment:
The intradermal application of the 0.5 % (w/w), 2 % (w/w) and 3.5 % (w/w) test substance in saline solution led to no reaction. The intradermal application on the 5 % (w/w) test substance in saline solution resulted only in a very slight reaction.The dermal application without Duhring chambers caused no erythema and edema formations with the moistened test substance and the 50 % (w/w) suspension in saline solution. The dermal application with Duhring chambers caused a slight reaction with the moistened test substance and very slight reaction with the 50 % (w/w) and 40 % (w/w) suspensions in saline solution. The application of a 20 % (w/w) suspension in saline solution elicited no skin reaction.
Induction:
The intradermal injection led to no to slight erythema and edema formation were detected with 5 % (w/w) solution of the test substance in saline solution after 24 hours. To induce skin reactions 10 % sodium lauryl sulphate in vaseline was applicated one day before dermal application. In the dermal induction phase no to slight erythema and edema formations were observed.
Challenge:
No erythema or edema formation were obsered in the test group and in the control group 24 h and 48 h post application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitisation rate of 0 % indicates that the test substance Creatinine is a non-sensitising copound in this test system.
- Executive summary:
Creatinine was tested regarding its sensitisation potential according to OECD 406 ("Skin Sensitisation"). Ten female guinea pigs of the strain "Pirbright White" were treated intradermally with 0.1 mL of a 5 % (w/w) soultion of the test substance in saline. (In contrast to the title of the study guinea pigs were used instead of rabbits. This is an error in the study report which does not have any influence on the study result.). For the dermal application 0.5 g of the test substance moistened with 0.5 mL saline solution was used. Intradermal application of the 5 % (w/w) solution of the test substance in saline caused no to slight erythema and edema formations. 24 hours before topical application of the moistened test substance animals were treated with 10 % sodium lauryl sulphate which resulted in no to slight erythema and edema formations. In the challenge application Duhring chambers with a 20 % (w/w) suspension of the test substance in saline was used, a concentration which was definitely a subirritative concentration.
Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. In the challenge no erythema and edema were observed at any time point. Therefore the test substance Creatinine has to be regarded as non-sensitizing under the applied test conditions when exposed to the skin of experimental animals.
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