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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - July 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:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany.
- Weight at study initiation: 2.1, 2.4 and 2.3 kg
- Housing: Individual caging in metal wire cages, Ehret GmbH, Emmendingen, type KK 016R, 79 cm x 59 cm bottom area, 38 cm height, with a wooden rest shelf, 15 cm x 59 cm.
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits, rich in crude fiber, ad libitu. Hay-briquettes (supplied by SSNIFF, 59494 Soest, Germany) was offered additionally as a dietry supplement.
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: 5 days (animal 1) and 12 days (animal 2 and animal 3)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 19.6 °C (continuous control and recording)
- Humidity (%): Average of 68.2 % (continuous control and recording)
- Photoperiod (hrs dark / hrs light): Artificial light from 6 a.m. to 6 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- The weighed amounts of the individual doses were 32, 36 and 31 mg.
- Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- Both eyes of the animals were examined within 24 hours before the installation and approximately 1, 24, 48 and 72 hours p.a. An additional examination was performed in 1/3 animals 6 days p.a.
- Number of animals or in vitro replicates:
- three females
- Details on study design:
- The test substance was administered the animals into the conjunctival sacs of the right eyes by gently pulling the lower lids away from the eyeballs for installation. The eyes were held closed for about one second to prevent a loss of test substance.
The left eye remained untreated and served as a control.
The whole eyes, especially the corneae, the irises and the conjunctivae were examined using an otoscope lamp.
In addition to the eye examiniations, the animals were observed for other than local changes.
Scoring scheme for eye lesions:
CORNEA
Opacity:Degree of density (area most dense i staken for reading)
0 No ulceration or opacity
1 scattered or diffuse areas of opacity (expect for slight dulling of normal lustre), details of iris clearly visible
2 Easily discernible translucent area, details of iris slightly obscured
3 Nacreous area, no details of iris visible, size of pupil barely discernible
4 Opaqua cornea, iris not discernible through the opacity
IRIS
0 Normal
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together)
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye)
0 Blood vessels normal
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes
0 No swelling
1 Any swelling above normal (includes nictating membranes)
2 Obvious swelling with partial eversion of lids
3 Swelling with lids about half closed
4 Swelling with lids more than half closed
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 53
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 53
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Remarks:
- 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Remarks:
- 53
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 6 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 53
- Time point:
- 24/48/72 h
- Score:
- > 0 - < 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hr
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The untreated eyes ("control eyes") were normal at each observation time.
The eyes, treated with the test substance ("test eyes") were normal before the instillation. After the instilllation of the test substance, the following findings were made:
Corneae: Not affected
Irises: Not affected
Conjunctivae, redness: A score of "1" in 1/3 animals from 24 h p.a. onwards until 72 h p.a.
Conjunctivae, chemosis: A sccore of "1" in 1/3 animals from 1 h p.a. until 24 h p.a. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After the instilllation of the test substance, the following findings were made:
Corneae: Not affected
Irises: Not affected
Conjunctivae, redness: A score of "1" in 1/3 animals from 24 h p.a. onwards until 72 h p.a.
Conjunctivae, chemosis: A sccore of "1" in 1/3 animals from 1 h p.a. until 24 h p.a.
Therefore 1,1 -Dimethylurea was classified as "non-irritant" to eyes. - Executive summary:
Possible irritation or corrosion by the test substance 1,1 -Dimethylurea was investigated by a single administration to a conjunctival sac of three rabbits. The study was performed in accordance with method B.5 of Directive 92/69/EEC.
The left eyes remained untreated and served as a control. Both eyes of the animals were examined within 24 hours before instillation and approximately 1, 24, 48 and 72 hours p.a. Eye irritation were scored and recorded. In addition to the eye examinations, the animals were observed for other than local changes at all observation times.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
The untreated eyes ("control eyes") were normal at each observation time.The eyes, treated with the test substance ("test eyes") were normal before the instillation. After the instilllation of the test substance, the following findings were made:
Corneae: Not affected
Irises: Not affected
Conjunctivae, redness: A score of "1" in 1/3 animals from 24 h p.a. onwards until 72 h p.a.
Conjunctivae, chemosis: A sccore of "1" in 1/3 animals from 1 h p.a. until 24 h p.a.
Therefore 1,1 -Dimethylurea was classified as "non-irritant" to eyes.
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