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EC number: 203-026-2 | CAS number: 102-36-3
- 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
Skin sensitisation: strong skin sensitiser (eq. to OECD 406, GLP, K, rel.2)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- 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: well documented and scientifically acceptable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- On day 1, 0.1 ml of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9 0.5 ml of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. The test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 9
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 24
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema, oedema
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- erythema, oedema
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Executive summary:
On day 1, 0.1 ml of the test substance was administered by intradermal route at the concentration of 0.1 % in paraffin oil and on day 9, 0.5 ml of the test substance was applied by cutaneous route at the concentration of 1%. After a period of 15 days without treatment, a challenge cutaneous application of the vehicle (left flank) and the test substance at the concentration of 1% (right flank) was performed in all the animals. the test substance and the vehicle were held in contact with the skin for 24 hours by an occlusive dressing. The cutaneous reactions were evaluated at the challenge application site, 24 hours and 48 hours after the removal of the dressing.
result: positive
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The sensitisation potential of 3,4-dichlorphenyl isocyanate was evaluated in the guinea-pig by intradermal route and cutaneous application, according to the maximisation method of Magnusson and Kligman. A positive result was found under the experimental conditions.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
According RL 1272/2008/EG (GHS) a classification as Skin Sens.1A (H 317: May cause an allergic skin reaction) is warranted, based on comparative analysis regarding other isocyanates isocyanates (p-isopropylphenylisocyanate_CAS 31027-31-3, n-butylisocyanante_CAS 111-36-4, 3,4-dichlorphenylisocyanante_CAS 102-36-3, 3,5-dichlorphenylisocyanate_CAS 28479-22-3, phenylisocyanate_CAS 103-71-9, trifluormethoxyphenylisocyanate_CAS 35037-73-1 are all strong sensitisers, classified as Skin Sens. 1A). No classification for respiratory sensitisation is necessary (see discussion below).
There are no data on respiratory sensitization available. p-tolyl isocyanate is a monoisocyanate. The UK Health and Safety Commission Working Group on the Assessment of Toxic Chemicals, Working Group on Action to Control Chemicals concluded performed an assessment of the potential for isocyanic acid and other monoisocyanates to cause respiratory irritation and sensitization (WATCH Committee Paper WATCH/2008/4, 17 Jun., 2008; http://www.hse.gov.uk/aboutus/meetings/iacs/acts/watch/170608/p4.pdf) and came to the following conclusion: “With the exception of methyl isocyanate, information on the toxicity of the monoisocyanates is sparse. There is no direct evidence that any of the monoisocyanates can cause respiratory sensitisation. … However, this indirect information on the allergenicity and immunoreactivity of the monoisocyanates is very limited, and insufficient to reliably inform on their potential to cause respiratory sensitisation.” A similar conclusion was drawn by the German MAK commission concerning the monoisocyanates in 2009 (MAK- und BAT-Werteliste 2009).
In addition it should be also mentioned that the ‘default’ assumption of the former EU hazard classification systems that all isocyanates have the potential to cause respiratory sensitisation is not in agreement with the strategy for evaluating respiratory sensitisation data in the Technical Guidance Document (TGD) on information requirements for REACH (R.7a; page 256ff). The TGD proposes that, in the absence of specific health effects data, only diisocyanates that also meet the criteria for classification for skin sensitisation are presumed to be respiratory sensitisers.
Justification for classification or non-classification
Harmonised classification:
The substance has no harmonised classification for skin/respiratory sensitisation according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
According RL 1272/2008/EG (GHS) a classification as Skin Sens.1A (H 317: May cause an allergic skin reaction) is warranted, based on comparative analysis regarding other isocyanates isocyanates (p-isopropylphenylisocyanate_CAS 31027-31-3, n-butylisocyanante_CAS 111-36-4, 3,4-dichlorphenylisocyanante_CAS 102-36-3, 3,5-dichlorphenylisocyanate_CAS 28479-22-3, phenylisocyanate_CAS 103-71-9, trifluormethoxyphenylisocyanate_CAS 35037-73-1 are all strong sensitisers, classified as Skin Sens. 1A). No classification for respiratory sensitisation is necessary (see discussion).
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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