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EC number: 943-625-2 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
There are two reliable studies available covering primary dermal and eye irritation potential in rabbits.
Among them an acute eye irritation/corrosion study according to OECD 405 and an acute dermal irritation study according to OECD 404. TDI-Urone is shown to be not irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The target substance consists of the same constituents as the source substance.
These constituents are 3-[3-(dimethylcarbamoylamino)-4-methylphenyl]-1,1-dimethylurea (CAS-No. 17526-94-2, EC-No. 241-523-6) and 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea (CAS-No. 17607-23-7, no EC-No. assigned). Due to the different typical concentrations of the main constituent and the 2nd constituent it became necessary to submit two registrations in order to distinguish between the mono-constituent substance (source) and the multi-constituent substance (target).
As the constituents of source and target are the same, the approach “read-across from supporting substance (structural analogue or surrogate)” is applicable because it is obvious that the physical-chemical, ecotoxicological and toxicological profiles are identical. - Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- no other effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item TDI-Urone is not considered to be irritating.
- Executive summary:
In a primary dermal irritation study according to OECD 404 three female New Zealand White Rabbits Crl:KBL (NZW) BR. were dermally exposed to 0.5 g of TDI-Urone for 4 hours to approximate 6 cm² of the skin on one side of the dorsal area. Animals then were observed for 3 days. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period. Therefore, TDI-Urone is not irritating to the skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-02 to 2001-04-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N" (4-Methyl-m-phenylen)bis(N',N'-dimethylharnstoff)
- Substance type: organic
- Physical state: odourless solid
- Analytical purity: 100%
- Lot/batch No.: 0232 07
- Expiration date of the lot/batch: March 2003
- Stability under test conditions: stable at dry storage conditions for at least 2 years
- Storage condition of test material: store sry in closed containers - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen.
- Age at study initiation:
- Weight at study initiation:
- Housing: semi-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/-3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 times per hour
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated other side of the dorsal area served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 h
- Observation period:
- Animals were observed for 72 hours after dosing
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: no data
- Type of wrap if used: gauze patch, held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using water
- Time after start of exposure: 4 h
SCORING SYSTEM: see table 1 in "Any other information on materials and methods" - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Other effects:
- no other effects
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item TDI-Urone is not considered to be irritating.
- Executive summary:
In a primary dermal irritation study according to OECD 404 three female New Zealand White Rabbits Crl:KBL (NZW) BR. were dermally exposed to 0.5 g of TDI-Urone for 4 hours to approximate 6 cm² of the skin on one side of the dorsal area. Animals then were observed for 3 days. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period. Therefore, TDI-Urone is not irritating to the skin.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-16 to 2001-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N"(4-Methyl-m-phenylen)bis(N',N'dimethylharnstoff)
- Substance type: organic
- Physical state: colourless solid
- Analytical purity:100%
- Purity test date: 01 March 2000
- Lot/batch No.: 023207
- Expiration date of the lot/batch: March 2003
- Storage condition of test material: store dry in closed containers
- Other: stable at dry storage conditions for at least 2 years - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: 4.7 kg, 4.3 kg, 3.0 kg
- Housing: Serni-barrier in air conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 55+/-10%
- Air changes (per hr): at 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
The properly grind test item was used as delivered by the sponsor. - Duration of treatment / exposure:
- as long as observation period. The eyes were not washed after treatment.
- Observation period (in vivo):
- Animals were observed 72 h respectively and furthermore until the disappea rance ofthe symptoms. This was achieved at 48 h for animal No 375, at 96 h ofanimal No 358 and at 192 h for animal No 357.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: At the end of the observation period the eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo®, Lot H 901). - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 0 - ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 144 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 358
- 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:
- 375
- 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:
- 357
- 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:
- 358
- 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:
- 375
- 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
- Basis:
- animal #1
- Remarks:
- 357
- Time point:
- 24/48/72 h
- Score:
- ca. 1 - ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 192 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 358
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 375
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 357
- 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:
- 358
- 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
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects:
- no other effects
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Conclusions:
- On the basis of the results it is concluded that TDI-Urone is slightly irritating to the eyes of rabbits but not relevant for classification.
- Executive summary:
In a primary eye irritation study according to OECD 405 0.1 g TDI-Urone were applied unchanged into the conjunctival sac of 3 female New Zealand White rabbits (Crl:KBL (NZW) BR). Eyes were not washed after treatment. Animals were observed 72 h respectively and furthermore until the disappearance of the symptoms. This was achieved at 48 h for animal No 375, at 96 h of animal No 358 and at 192 h for animal No 357. Irritation was scored by the method of Draize.
The test item produced redness of the conjunctivae in all three animals as well as opacity of the comea in one animal. Effects were fully reversible.
No comeal lesions were found upon fluorescein examination at the final readings.
In this study TDI-Urone was found to be slightly irritating to the eyes of rabbits but not relevant for classification.
Reference
Table 1: Individual eye irritation scores
Animal number |
Hour p.a. |
Cornea |
Iris |
Conjunctivae |
||
A |
B |
C |
||||
T/C |
T/C |
T/C |
T/C |
T/C |
||
357 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
1/0 |
0/0 |
2/0 |
0/0 |
0/0 |
|
72 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
120 |
1/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
144 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
168 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
192 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
358 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
96 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
375 |
1 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
24 |
0/0 |
0/0 |
1/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
T=Test, C=Control; A=Redness; B=Chemosis; C=Discharge;
marked figures=used for calculation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
TDI-Urone is non-irritating to the skin. The test item showed no irritant effects on the intact skin after a contact time of 4 hours. No skin reactions were recorded throughout the observation period of 72 hours as compared to untreated control sites. There were no significant body weight changes during the contact and observation period.
In an acute eye irritation study TDI-Urone produced redness of the conjunctivae in all three animals as well as opacity of the comea in one animal. Effects were fully reversible. No comeal lesions were found upon fluorescein examination at the final readings.
In this study TDI-Urone was found to be slightly irritating to the eyes of rabbits but not relevant for classification.
Justification for classification or non-classification
TDI-Urone is neither irritating/corrosive to the skin nor irritating to the eyes based on the results of appropriate guideline studies.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.