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EC number: 241-523-6 | CAS number: 17526-94-2
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-04-02 to 200105-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was already performed in 2001 and is sufficient for non-classification
Test material
- Reference substance name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- EC Number:
- 241-523-6
- EC Name:
- N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]
- Cas Number:
- 17526-94-2
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 1-{5-[(dimethylcarbamoyl)amino]-2-methylphenyl}-3,3-dimethylurea
- Reference substance name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Cas Number:
- 17607-23-7
- Molecular formula:
- C13H20N4O2
- IUPAC Name:
- 3-[3-(dimethylcarbamoylamino)-2-methylphenyl]-1,1-dimethylurea
- Reference substance name:
- unknown
- IUPAC Name:
- unknown
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
impurity 3
- Specific details on test material used for the study:
- - Substance type: organic
- Physical state: colourless solid
- Analytical purity: 100%
- Purity test date: 01 March 2000
- Lot/batch No.: 0232 07
- 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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: no data
- Weight at study initiation: 300- 500 g
- Housing: The animals were barrier maintained (semi-barrier) in air conditioned rooms and were kept in groups in Terluran-cages on Altromin saw fiber bedding. Max. group size 10 animals
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3° C
- Humidity (%): 55±10%
- Air changes (per hr): 10x/hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5 % / 0.1 ml
- Day(s)/duration:
- 7 d
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % / 0.5 ml
- Day(s)/duration:
- 48 h
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 25 % / 0.5 ml
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 female test animals, 5 female control animals and 6 female animals for range finding
- Details on study design:
- RANGE FINDING TESTS: For the justification of dose levels a preliminary test as performed. Three animals were treated intradermally with 0.5%, 1%, 2.5%, 5% concentration ofthe test item and three animals were topically treated with 5%, 10%, 25% concentration of the test item.
MAIN STUDY
A. INDUCTION EXPOSURE
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region which was cleared of hair so that one of each pair lies on each side of the midline.
- No. of exposures: 3
Induction: First Stage, Intradermal Injection
Test group: Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: Prepared test item
Injection 3: Prepared test item at a concentration of 50% (VN) in Freund's
Adjuvant complete, 1+1 (v/v) diluted with isotonic saline.
Control group : Day 0
Injection 1: Freund's Adjuvant complete, 1+1 (v/v) diluted with isotonic saline
Injection 2: NaCl 0,9%
Injection 3: NaCl 0,9% at a concentration of50% (VIV) in Freund's
Adjuvant complete, 1+1 (v/v) diluted with isotonic saline.
lnduction: Second Stage, Topical Application
Day 6: Test and control group
Approximately twenty-four hours before the topical induction application the test area, after close clipping was painted with 0.5 ml of 10% sodium lauryl sulfate in vaseline, in order to create a local irritation.
Test Group: Day 7
A patch was loaded with 0.5 ml of the test item at a 25% concentration, applied to the test area and held in contact by an occlusive dressing for 48 hours.
Control Group: Day 7
A patch was loaded with 0.5 ml of vehicle and applied to the test area and held in contact by an occlusive dressing for 48 hours.
- Exposure period: 7 days
- Test groups: 1
- Control group: 1
- Site: shoulder region
B. CHALLENGE EXPOSURE: topiccal application
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 h
- Test groups: 1
- Control group: 1
- Site: flanks
- Concentrations: A patch loaded with 0.5 ml of the test item (25%) was applied to the left flank of the animals and, a patch loaded with 0.5 ml vehicle to the right flank (intraspecific control), respectively. The patches were held in contact by an occlusive dressing for 24 hours. At the end of the challenge skin was cleaned with the aid of moistened ganze patches.
- Evaluation (hr after challenge): 24 h, 48 h and 72 h
Approximately 21 hours after removing the patch the challenge area was cleaned and cleared of hair. Approximately 24 hours after removing of the patch the skin reaction was observed and recorded according to the grades shown below. Two more observations were recorded 48 and 72 hours after patch removal. - Challenge controls:
- 0.5 ml of the vehicle was applied to the right flank (intraspecific control).
- Positive control substance(s):
- yes
- Remarks:
- Mercaptobenzothiazole
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- 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:
- 25%
- 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:
- 25%
- 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:
- 25%
- 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 % induction I; 25 % induction II: 15 % challenge
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema Grade 1 + 2; Oedema Grade 1
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this sensitization test it can be stated that the test item TDI-Urone caused no reactions identified as sensitization.
- Executive summary:
In a dermal sensitization study according to OECD 406 with TDI urone in 0.9%NaCl (5% TDI-Urone) and Vaseline (25% TDI-Urone), respectively, Hsd Poc:DH guinea pigs (10 females in the test group, 5 females in the control group and 6 females for range-finding study) were tested using the method of Guinea-Pig Maximisation Test.
During the induction phase the guinea pigs were intradermally injected with 5% TDI-Urone and, after treatment with sodium lauryl sulfate, topically treated with 25%TDI-Urone. After a latency of 2 weeks the animals were challenged with 25% TDI-Urone on the flank. The grade of skin reactions was compared to control animals, which were treated with isotonic saline resp. vaseline during the induction phase and, during the challenge phase with the test item, respectively.
No skin reactions were observed throughout the study. Therefore, the skin sensitization rate after application of TDI-Urone was 0 %. Under the test conditions TDI-Urone showed no sensitizing properties. Animals of the test group showed normal weight gain as compared to historical data and the animals of the control group.
In this study, TDI-Urone is not a dermal sensitizer.
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.
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