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EC number: 222-852-4 | CAS number: 3634-83-1
- 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://poisoncentres.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:
- 12 March-18 April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study was performed before non-animal tests or the local lymph node assay were available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: Magnusson, B. and Kligman, AM (1970). Allergic Contact Dermatitis in the guinea pig: identification of contact allergens, Thomas, CC Springfield, Illinois, USA
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the LLNA was available.
Test material
- Reference substance name:
- 1,3-bis(isocyanatomethyl)benzene
- EC Number:
- 222-852-4
- EC Name:
- 1,3-bis(isocyanatomethyl)benzene
- Cas Number:
- 3634-83-1
- Molecular formula:
- C10H8N2O2
- IUPAC Name:
- 1,3-bis(isocyanatomethyl)benzene
- Details on test material:
- - Name of test material (as cited in study report): Takenate 500 = 1,3-bis (isocyanatomethyl)benzene
- Physical state: colourless/pale yellow clear liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, UK
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 451 to 524 g
- Housing: animals were housed in groups of five in suspended metal cages with mesh floors.
- Diet (e.g. ad libitum): ad libitum (Vitamin C enriched guinea pig diet FD2)
- Water (e.g. ad libitum): ad libitum
- Acclimatisation period: twelve days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5-21
- Humidity (%): 24-61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Preliminary study:
For Intradermal concentrations 0.001%, 0.0025%, 0.005%, 0.01%, 0.025%, 0.05%, and 0.1% v/v
For Topical concentrations: 0.5%, 1%, 2.5%, 5%, 7.5%, 10%, 15% and 20%, 30%, 50%, 70%, 100% v/v
Main study:
Intradermal injection: 0.01% v/v (highest concentration in preliminary study, causing irritation but not adversely affecting the animals)
Topical application: 100%
Challenge application: 15 and 7.5% v/v (15% was the highest concentration not giving rise to irritating effects)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Preliminary study:
For Intradermal concentrations 0.001%, 0.0025%, 0.005%, 0.01%, 0.025%, 0.05%, and 0.1% v/v
For Topical concentrations: 0.5%, 1%, 2.5%, 5%, 7.5%, 10%, 15% and 20%, 30%, 50%, 70%, 100% v/v
Main study:
Intradermal injection: 0.01% v/v (highest concentration in preliminary study, causing irritation but not adversely affecting the animals)
Topical application: 100%
Challenge application: 15 and 7.5% v/v (15% was the highest concentration not giving rise to irritating effects)
- No. of animals per dose:
- 10 test and 5 control
- Details on study design:
- RANGE FINDING TESTS: Selection of concentrations for main study
Intradermal induction: 0.001%, 0.0025%, 0.005%, 0.01%, 0.025%, 0.05% and 0.1% were injected. The highest concentration causing only mild to moderate skin irritation, and which was well tolerated systemically was selected for intradermal induction.
Topical induction: 0.5%, 1%, 2.5%, 5%, 7.5%, 10%, 15%, 20%, 30%, 50%, 70% and 100% was applied, highest concentration producing only mild to moderate dermal irritation was selected.
Topical challenge: 15%, 7.5% were applied occlusively for a period of 24 hours. The highest non irritant concentration and one lower concentration were selected for the topical challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three injections, 0.1 ml each: Freund's Complete Adjuvant plus water in ratio 1:1, a 0.01% v/v formulation of the test substance in Alembicol D, a 0.01% v/v formulation of the test substance in a 50:50 mixture of Freund's Complete Adjuvant plus Alembicol D.
- Exposure period: One week later Day 7, same region was clipped again and treated with a topical application (0.4 ml) of a paper saturated with the undiluted test material. An occlusive dressing was kept in place for 48 hours.
- Control group: Identical procedure as test animals, except test substance was omitted.
- Site: 40x60 mm area, hair was removed on the shoulder region
- Duration: 21 days
B. CHALLENGE EXPOSURE
- Day(s) of challenge: Day 21, two weeks after topical induction.
- Exposure period: A filter paper saturated with approx. 0.2 ml of 15% v/v test substance was applied to an anterior site of the flank. A filter paper saturated with 7.5% v/v test substance was applied to the posterior site. Patches were occluded. After 24 hours of occlusive dressing this was removed.
- Control group: All animals were treated the same.
- Site: An area on left flank of each animal was clipped free of hair.
- Evaluation (hr after challenge): 24 + 48 after removal of dressing - Positive control substance(s):
- yes
- Remarks:
- periodically checked with known sensitisers, hexyl cinnamic aldehyde (HCA), benzocaine and 2-mercaptobenzothiazole (MBT)
Results and discussion
- Positive control results:
- Summary of positive control data from 1995 and 1996: 6/10 for benzocaine, 8/10 and 10/10 for HCA, 10/10 (twice) for MBT
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 7.5% and 15%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Same results at 48 hours. Necrosis occured in one animal, necrotic patch in several animals, thickening, dryness and sloughinig of the epidermis occured also in one animal.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5% and 15%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Same results at 48 hours. Necrosis occured in one animal, necrotic patch in several animals, thickening, dryness and sloughinig of the epidermis occured also in one animal. .
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 7.5% and 15%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- Same results at 48 hours. No observations.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5% and 15%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: Same results at 48 hours. No observations..
Any other information on results incl. tables
No signs of ill health or toxicity were noted. Bodyweight increases in test group animals were comparable to control group animals. During induction, slight irritation was seen in test and control animals after intradermal injections, slight erythema was observed after topical application in test and control animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- Takenate 500 produced evidence of skin sensitisation (delayed contact hypersensitivity) in all of the ten test animals. Classification with risk phrase R43 is warranted.
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