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EC number: 203-674-6 | CAS number: 109-46-6
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- no detailed data about induction conditions
Data source
Reference
- Reference Type:
- publication
- Title:
- A new protocol and criteria for quantitative determination of sensitization potencies of chemicals by guinea pig maximization test.
- Author:
- Nakamura A, Momma, Sekiguchi H, Noda T, Yamano T, Kaniwa MA, Kojima S, Tsuda M abd Kurokawa Y.
- Year:
- 1 994
- Bibliographic source:
- Contact Dermatitis 1994 ; 31 : 72-85.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Magnusson and Kligman J. Invest. Dermatol 1969 ; 52 : 268-276
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An old GPMT was available in the publication. No new study was performed for skin sensitisation endpoint for REACH regulation.
Test material
- Reference substance name:
- 1,3-dibutyl-2-thiourea
- EC Number:
- 203-674-6
- EC Name:
- 1,3-dibutyl-2-thiourea
- Cas Number:
- 109-46-6
- Molecular formula:
- C9H20N2S
- IUPAC Name:
- 1,3-dibutyl-2-thiourea
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: olive oil (intradermal induction), petrolatum (topical induction) and acetone (challenge)
- Concentration / amount:
- Induction / intradermal injection : 0, 2, 20, 200, 2000 ppm
Induction / topical : 0, 250 000 ppm
Challenge / topical : 0, 0.2, 2, 20, 200, 2000 ppm
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: olive oil (intradermal induction), petrolatum (topical induction) and acetone (challenge)
- Concentration / amount:
- Induction / intradermal injection : 0, 2, 20, 200, 2000 ppm
Induction / topical : 0, 250 000 ppm
Challenge / topical : 0, 0.2, 2, 20, 200, 2000 ppm
- No. of animals per dose:
- 10 per group
- Details on study design:
- Challenge : On day 22, all the animals received a topical open application of 0.1 ml of the test substance in their right flank (while their left flank received the vehicle).
- Clinical examinations: no
- Mortality: no
- Body weight: no
- Necropsy: no - Challenge controls:
- no
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- negative control
- Dose level:
- no induction
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects with a challenge of 0 - 0.2 - 2 - 20 - 200 and 2000 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 2 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects at challenge concentrations (0 - 0.2 - 2 - 20 - 200 and 2000 ppm)
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- intradermal induction of 20 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects at challenge concentration of 0 - 0.2 - 2 and 20 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- intradermal induction of 20 ppm
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- at challenge concentrations of 200 ppm
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- intradermal Induction of 20 ppm
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- At challenge concentration of 2000 ppm
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Interdermal induction of 200 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects at challenge concentration of 0 - 0.2 - 2 - 20 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal concentration of 200 ppm
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- at challenge concentration of 200 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 200 ppm
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- At challenge concentration of 2000 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 2000 ppm
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No effects at challenge concentrations of 0 - 0.2 and 2 ppm
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 2000 ppm
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- at challenge concentration of 20 ppm
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 2000 ppm
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- At challenge concentration of 200 ppm
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- Intradermal induction of 2000 ppm
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- At challenge concentration of 2000 ppm
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
No redness was observed in the control animals (in animals not induced but challenged, and in animals not induced and not challenged).
In the test groups (induced and challenged), a positive effect (redness in more 30% of animal) was observed at the induction concentration of 200 ppm (0.02%) at 200 and 2000 ppm of challenge doses (60 and 80% respectively).
This positive effect was confirmed at the induction concentration of 2000 ppm.
DBTU is a skin sensitizer according to this GPMT test.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- According this Guinea pigs maximalisation test, DBTU is a skin sensitizer .
- Executive summary:
A guinea pigs maximalisation test was performed according to the Magnuson and Kligman method with DBTU.
In induction phase, guinea pigs were exposed by intradermal injection (0, 2, 20, 200, 2000 ppm of DBTU) and by topical administration (250 000 ppm of DBTU).
In the challenge phase, animals were exposed by topical administration at : 0, 0.2, 2, 20, 200 or 2000 ppm of DBTU.
No redness was observed in the control animals (in animals not induced but challenged, and in animals not induced and not challenged).
In the test groups (induced and challenged), a positive effect (redness in more 30% of animal) was observed at the induction concentration of 200 ppm (0.02%) at 200 and 2000 ppm of challenge doses (60 and 80% respectively).
This positive effect was confirmed at the induction concentration of 2000 ppm.
DBTU is a skin sensitizer according to this GPMT test.
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