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EC number: 209-957-0 | CAS number: 598-94-7
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April - June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,1-dimethylurea
- EC Number:
- 209-957-0
- EC Name:
- 1,1-dimethylurea
- Cas Number:
- 598-94-7
- Molecular formula:
- C3H8N2O
- IUPAC Name:
- 1,1-dimethylurea
- Reference substance name:
- Urea
- EC Number:
- 200-315-5
- EC Name:
- Urea
- Cas Number:
- 57-13-6
- Molecular formula:
- CH4N2O
- IUPAC Name:
- urea
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- solid: crystalline
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- - Analytical purity: at least 98 %
- Impurities (identity and concentrations): max. 2 % Urea, max. 0.2 % Isopropanol, max. 0.5 % diethyleneglycolmonoethylether
- Lot/batch No.: KG 03-13
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, 33176 Borchen, Germany
- Age at study initiation: about 8 weeks at the first administration
- Weight at study initiation: 16.9 g - 20.8 g
- Housing: Single caging. Makrolon cages type II, (22 cm x 16.5 cm ground area, 15 cm high)
- Diet (e.g. ad libitum): Altromin maintenance diet for rats and mice, item No. 1324forte, ad libitum
- Water (e.g. ad libitum): Tap water offered in Makrlon-bottles with stainless steel canules, ad libitum.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 21.8 °C (continuous monitoring and recording)
- Humidity (%): Average of 55.7 % (continuous monitoring and recording)
- Photoperiod (hrs dark / hrs light): only artifical light from 6.00 a.m. to 6 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- Group A (low dose): 2.5 % solution of 1,1-Dimethylurea in Propyleneglycol.
Group B (mid dose): 5 % solution of 1,1-Dimethylurea in Propyleneglycol.
Group C (high dose): 7.2 % (w/w) solution of 1,1-Dimethylurea in Propyleneglycol. - No. of animals per dose:
- five females per group
- Details on study design:
- see "any other information on material and methods incl. tables"
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Application of 25 % Hexyl Cinnamic Aldehyde in Acetone:olive oil (4:1, v/v) resulted in an SI (Stimulation Index) of 35.8. This result proves the sensitivity of the strain of animals used and the reliability of the experimental technique.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- negative control
- Key result
- Parameter:
- SI
- Value:
- 2.8
- Test group / Remarks:
- low dose
- Key result
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- mid dose
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- high dose
- Parameter:
- SI
- Value:
- 35.8
- Test group / Remarks:
- positive control
Any other information on results incl. tables
Mortality:
All animals survived till the end of the study.
General observations:
One animal of the positive control group had reduced motor activities on Day 2, which is not of relevance for the results. No adverse effects were noted in this animal on the other days and in all other animals throughout the whole study.
Skin reactions:
No local irritations were observed at the application sites of all animals of the test substance groups and both control groups throughout the whole study.
Body mass:
Body masses and body mass gains of all animals were in the range of to be expected from animals of the same strain, sex and age. Body weight loss was noted in 1/5 animals in the negative control group.
Calculation of the stimulation indices (SIs)
The SIs of the substance groups were between 0.7 and 2.8. There was no concentration related response.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Although one SI value is very near the limit of 3, 1,1 -Dimethylurea is regarded as a non sentiser in the LLNA, since the SIs of all examines test substance concentrations were smaller than 3 and no concentration related response was observed.
- Executive summary:
A Local Lymph Node Assay was performed according to OECD Guideline 429 to evalute a possible skin sensitising potential of 1,1 -Dimethylurea.
Three test substance concentrations (2.5, 5 and 7.2 % solution of 1,1 -Dimethylurea in 1,2 -Propanediol) were administered to three groups of 5 female CBA/Ca mice. All animals survived till the end of the study. One animal of the positive control group had reduced motor activities on Day 2, which is not of relevance for the results. No adverse effects were noted in this animal on the other days and in all other animals throughout the whole study. No local irritations were observed at the application sited of all animals of all test substance groups and both control groups throughout the whole study. Body masses and body mass gains of all animals were in the range to be expected from animals of the same strain, sex and age.
The SIs of the tested test substance concentrations were 2.8 (low dose), 1.1 (mid dose) and 0.7 (high dose). Although one SI value is very near the limit of 3, 1,1 -Dimethylurea is regarded as a non sentiser in the LLNA, since the SIs of all examines test substance concentrations were smaller than 3 and no concentration related response was observed.
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