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EC number: 202-039-0 | CAS number: 91-08-7
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Concentration-Dependent Elicitation of Dermal Sensitization in Guinea Pigs Treated with 2,4-Toluene Diisocyanate
- Author:
- FRANCIS J. KOSCHIER, EDWARD J. BURDEN, CINDY S. BRUNKHORST, AND MARVIN A. FRIEDMAN
- Year:
- 1 983
- Bibliographic source:
- TOXICOLCCY AND APPLIED PHARMACOLOGY 67,401-407 (1983)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- An open epicutaneous test was performed on guinea pigs to evaluate the significance of dermal hypersensitization of 2, 4-Toluene diisocyanate (TDI).
- GLP compliance:
- not specified
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- 2,4-Toluene diisocyanate
- IUPAC Name:
- 2,4-Toluene diisocyanate
- Reference substance name:
- 4-methyl-m-phenylene diisocyanate
- EC Number:
- 209-544-5
- EC Name:
- 4-methyl-m-phenylene diisocyanate
- Cas Number:
- 584-84-9
- IUPAC Name:
- 2,4-diisocyanato-1-methylbenzene
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Toluene diisocyanate (TDI)
- Molecular formula: C9H6N2O2
- Molecular weight: 174.1584 g/mol
- Substance type: Organic
- Physical state: liquid
-Smiles: Cc1ccc(cc1N=C=O)N=C=O
- InChI: 1S/C9H6N2O2/c1-7-2-3-8(10-5-12)4-9(7)11-6-13/h2-4H,1H3
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals, Inc. (Scottdale. Pa.) Or Camm Breeding Laboratories, Inc. (Wayne, N.J.).
- Age at study initiation: young guinea pigs
- Weight at study initiation: no data
- Housing: housed individually in stainless-steel cages with wire-mesh bottoms
- Diet (e.g. ad libitum): Certified Guinea Pig Chow 5026 (Ralston Purina Co. ad libitum
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): (21 ± 2°C)
- Humidity (%): 40-60%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): Twelve hours of continuous fluorescent lighting was provided daily.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: n-Butyl ether was the solvent because of its versatility in preparation of liquid or solid diisocyanates.
- Concentration / amount:
- Induction concentration:0, 8, 20, or 40%
Challenge concentration: 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: n-Butyl ether was the solvent because of its versatility in preparation of liquid or solid diisocyanates.
- Concentration / amount:
- Induction concentration:0, 8, 20, or 40%
Challenge concentration: 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%
- No. of animals per dose:
- 5 guinea pigs/ group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: 5 guinea pigs
- Control group: 5 guinea pigs
- Site: The animals in each induction group received a total application of 50.0 µl of solution with each animal receiving two 25 µl amounts on separate sites.
- Frequency of applications: no data
- Duration:5 days
- Concentrations: 0, 8, 20, or 40%
B. CHALLENGE EXPOSURE
- No. of exposures: each guinea pig received six challenge applications of TDI in 25 µl aliquots.
- Day(s) of challenge: Five days later induction
- Exposure period: 24 hours
- Test groups: 5 guinea pigs
- Control group: 5 guinea pigs
- Site: The challenge applications were on virgin sites and consisted of one n-butyl ether application and five TDI concentrations
- Concentrations: 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%
- Evaluation (hr after challenge): 24 hours
C. RECHALLENGE EXPOSURE
- No. of exposures: each guinea pig received six challenge applications of TDI in 25 µl aliquots.
- Day(s) of challenge: 14 days after induction
- Exposure period: 24 hours
- Test groups: 5 guinea pigs
- Control group: 5 guinea pigs
- Site: The challenge applications were on virgin sites and consisted of one n-butyl ether application and five TDI concentrations
- Concentrations: 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%
- Evaluation (hr after challenge): 24 hours
OTHER: The hair on the dorsum was clipped 24 hr before the induction concentration was applied. - Challenge controls:
- Yes concurrent vehicle
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- 100% of the animals had dermal reactions when challenged with 0.1 to 0.4% TDI.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4%. No with. + reactions: 5.0. Total no. in groups: 5.0. Clinical observations: 100% of the animals had dermal reactions when challenged with 0.1 to 0.4% TDI. .
Any other information on results incl. tables
All challenge applications except the 0.0% solution elicited a positive response in 75 to 100% of the animals, and the severity of the skin reactions was dependent on the concentrations of the challenge and induction application.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material 2, 4-Toluene diisocyanate (CAS No: -584-84-9) was considered to be sensitizing on guinea pigs by open epicutaneous test
- Executive summary:
Skin sanitization study was conducted on guinea pigs via open epicutaneous test for test chemical2, 4-Toluene diisocyanate(CAS No: -584-84-9) for exposure period of 24 hours and skin reactions were scored.
This study was designed to determine the concentration-dependent elicitation of dermal sensitization in guinea pigs treated with TDI. In this study, young adult guinea pigs received two open, epicutaneous induction applications (25 µL) of 8, 20, or 40% TDI in n-butyl ether on two separate areas.During induction at 20 and 40%concentrations, both the 24- and 48-hr readings (2.0) were much greater than those for the solvent group.
Five days later, animals were challenged with 0.0, 0.025, 0.05, 0.1, 0.2, and 0.4% TDI (25 µL per concentration site). The vehicle application did not produce any significant reactions at challenge. On the other hand, 0.025 to 0.4% TDI produced mean scores of 2.0 to 4.2 in all three TDI groups.All challenge applications except the 0.0% solution elicited a positive response in 75 to 100% of the animals.
Fourteen days after induction, the 8, 20, and 40% groups were rechallenged and the 0% group was challenged. Control animals did not respond with dermal hypersensitivity reactions when challenged with applications of n-butyl ether or TDI. For the TDI-induction groups, 100% of the animals had dermal reactions when challenged with 0.1 to 0.4% TDI, and the severity of the skin reactions was dependent on the concentrations of the challenge and induction application.
Based upon the observations the test material2, 4-Toluene diisocyanate(CAS No: -584-84-9)was considered to be sensitizing on guinea pigs.
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