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EC number: 203-137-6 | CAS number: 103-71-9
- 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:
- other: scientifically acceptable and sufficient documented
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 J, Sekiguchi H, Noda T, Yamano T, Kaniwa MA, Kojima S, Tsuda M, Kurokawa Y
- Year:
- 1 994
- Bibliographic source:
- Contact deramitis 31, 72-85 (1994)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The sensitization test was performed almost in accordance with the original procedure of Magnusson and Kligman with some modifications. Female albino guinea pigs of the Hartley strain were used as experimental animals. Five animals were used in each experimental group. Each group of animals was sensitized by injection of given concentration of the chemical. 21 days after the initial intradermal injection, 0.1 ml aliquots of various concentrations of test chemical in the vehicle were applied to the shaved area of the flank of each animal for challenge. All concentrations adopted are lower than the irritant concentrations. The challenge was done by the open patch test method. The chemical was left in place for 24 hours.
Dermal response of each challenge site was evaluated 48 h after the challenge application. Evaluation of skin reactions was done by scoring erythema and edema formation of each challenge concentration. - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was published 1994. At this time an OECD guideline for a LLNA was not available.
Test material
- Reference substance name:
- Phenyl isocyanate
- EC Number:
- 203-137-6
- EC Name:
- Phenyl isocyanate
- Cas Number:
- 103-71-9
- Molecular formula:
- C7H5NO
- IUPAC Name:
- isocyanatobenzene
- Details on test material:
- PIC (phenyl isocyanate) was purchased from Tokyo Kasei Kogyo Co. Ltd.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: induction: intradermal injection/topical = ethanol/propylene glycol; Challenge: topical = acetone
- Concentration / amount:
- Induction -intradermal injection. 0, 200, 2000 ppm
Induction - topical: 0, 2000 ppm
Challenge - topical: 0, 2, 20, 200, 2000 ppm
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: induction: intradermal injection/topical = ethanol/propylene glycol; Challenge: topical = acetone
- Concentration / amount:
- Induction -intradermal injection. 0, 200, 2000 ppm
Induction - topical: 0, 2000 ppm
Challenge - topical: 0, 2, 20, 200, 2000 ppm
- No. of animals per dose:
- Five animals per dose were used in each experimental group
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 0 ppm
- Dose level:
- 0 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 0 ppm. Dose level: 0 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 2 ppm
- Dose level:
- 2 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 2 ppm. Dose level: 2 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 20 ppm
- Dose level:
- 20 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 20 ppm. Dose level: 20 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 200 ppm
- Dose level:
- 200 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 200 ppm. Dose level: 200 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 2000 ppm
- Dose level:
- 2000 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 0 ppm, induction topical: 0 ppm, challenge 2000 ppm. Dose level: 2000 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 0 ppm
- Dose level:
- 0 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 0 ppm. Dose level: 0 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 2 ppm
- Dose level:
- 2 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 2 ppm. Dose level: 2 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 20 ppm
- Dose level:
- 20 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 20 ppm. Dose level: 20 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 200 ppm
- Dose level:
- 200 ppm (challenge)
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 200 ppm. Dose level: 200 ppm (challenge). No with. + reactions: 3.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 2000 ppm
- Dose level:
- 2000 ppm (challenge)
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 200 ppm, induction topical: 20000 ppm, challenge 2000 ppm. Dose level: 2000 ppm (challenge). No with. + reactions: 5.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 0 ppm
- Dose level:
- 0 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 0 ppm. Dose level: 0 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 2 ppm
- Dose level:
- 2 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 2 ppm. Dose level: 2 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 20 ppm
- Dose level:
- 20 ppm (challenge)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 20 ppm. Dose level: 20 ppm (challenge). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 200 ppm
- Dose level:
- 200 ppm (challenge)
- No. with + reactions:
- 3
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 200 ppm. Dose level: 200 ppm (challenge). No with. + reactions: 3.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 2000 ppm
- Dose level:
- 2000 ppm (challenge)
- No. with + reactions:
- 4
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: other: induction intradermal: 2000 ppm, induction topical: 20000 ppm, challenge 2000 ppm. Dose level: 2000 ppm (challenge). No with. + reactions: 4.0. Total no. in groups: 5.0.
Any other information on results incl. tables
With an induction of 2 or 20 ppm no skin sensitization (0/5) were found, but an induction of 200 ppm (3/5) or 2000 ppm (4/5 and 5/5) animals revealed clear signs of skin sensitization. A maximal reaction was found with an intradermal induction with 200 ppm and a topical induction with 2000 ppm followed by a challenge with 2000 ppm. As a result phenyl isocyanate was positive under the conditions of this assay.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Skin Sens. 1A is justified.
- Executive summary:
The sensitization test was performed almost in accordance with the original procedure of Magnusson and Kligman with some modifications. Female albino guinea pigs of the Hartley strain were used as experimental animals. Five animals were used in each experimental group. Each group of animals were sensitized by injection of given concentration of the chemical. 21 days after the initial intradermal injection, 0.1 ml aliquots of various concentrations of test chemical in the vehicle were applied to the shaved area of the flank of each animal for challenge. All concentrations adopted are lower than the irritant concentrations. the challenge was done by the open patch test method. the chemical was left in place for 24 hours.
Dermal response of each challenge site was evaluated 48 h after the challenge application. Evaluation of skin reactions was done by scoring erythema and edema formation of each challenge concentration.
With an induction of 2 or 20 ppm no skin sensitization (0/5) were found, but an induction of 200 ppm (3/5) or 2000 ppm (4/5 and 5/5) animals revealed clear signs of skin sensitization. A maximal reaction was found with an intradermal induction with 200 ppm and a topical induction with 2000 ppm followed by a challenge with 2000 ppm. As a result phenyl isocyanate was positive under the conditions of this assay.
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