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Diss Factsheets
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EC number: 939-340-8 | CAS number: 28182-81-2
- 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://www.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:
- supporting study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study. It was not specified whether the study was conducted in accordance with GLP or not.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 28182-81-2
- Molecular formula:
- Unspecified (UVCB substance)
- Reference substance name:
- HDI oligomers, biuret
- EC Number:
- 939-340-8
- Cas Number:
- 28182-81-2
- Molecular formula:
- (C8H12N2O2)n
- IUPAC Name:
- HDI oligomers, biuret
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo; Ani Labo; Gwen Meur; Shamrock Farms
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 300 to 500 g
- Housing: in groups of 5 (gender separated) in polystyrene cages
- Diet: 50 g per animal per day (granules cobaye Extra Labo)
- Water: softened and filtered water, ad libitum
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 3
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 times per hour (pre-filtered air: 5-10 µL)
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction:
intradermal - 0.05 % (v/v), occlusive topical - 10 % (v/v)
Challenge:
occlusive topical - 2.5 % (v/v)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction:
intradermal - 0.05 % (v/v), occlusive topical - 10 % (v/v)
Challenge:
occlusive topical - 2.5 % (v/v)
- No. of animals per dose:
- 10 (controls), 20 (test groups)
- Details on study design:
- PRE-STUDY:
Following test substance concentrations were determined within a üre-study:
- The concentration at which the test substance provokes a weak to moderate irritation by intradermal route and by topical application under occlusive patch-test for 48 hours on a cutanous area of 8 cm2.
- The concentration at which this test substance produces no pathological cutaneousreaction by topical application under occlusive patch-test for 24 hours an a surface of 4 cm2.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal), 48 hours (epicutaneous)
- Test groups:
Intradermal - 2x 0.1 mL injections; 1) test substance (0.05 % (v/v)) diluted in liquid paraffin; 2) 50/50 (v/v) mixing of test substance (0.1 % (v/v)) in liquid paraffin with Freund complete adjuvant (at 50 % (v/v))
Epicutaneous: 10% test substance in vehicle (liquid paraffin)
- Control group:
Intradermal - 2x 0.1 mL injections; 1) liquid paraffin; 2) 50/50 (v/v) mixing of liquid paraffin with Freund complete adjuvant (at 50 % (v/v))
Epicutaneous: vehicle (liquid paraffin)
- Site: scapular region on each side of the spine
- Frequency of applications: once
- Duration: 0-7 days
- Concentrations: intradermal 0.05 %, epicutaneous, 10 %
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 21
- Exposure period: 24 hours
- Test groups/control group: test substance in vehicle
- Site: on the left and right flanks, a region that has never been treated before
- Concentrations: 2.5 %
- Evaluation (hr after challenge): 1, 6, 24 and 48 hours
- The intensity of erythematous and oedematous reactions is scored according to the following scale :
No reaction-0
Slight erythema (hardly visible)-1
Moderate erythema (well visible)-2
Severe erythema with oedema-3
Any other anomalies are also noted, e.g. vesicles, thickening or skin dryness.
- skin samples for histopathological evaluation were taken from animals with scores 1-3. - Positive control substance(s):
- yes
- Remarks:
- data obtained in the testing facilities in 1982 with reference substances, were listed as appendix in the study report.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5 %
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- signs of allergy
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5 %. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: signs of allergy.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Category 1A
DSD: R43
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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