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EC number: 406-550-1 | CAS number: - MDI
- 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
- Study period:
- July 3, 1990 - September 27, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1984)
- Deviations:
- no
- Principles of method if other than guideline:
- "Experimental Skin Sensitization in the Guinea pig and Man", Buehler E.V. and Griffith F. in: Animal models in dermatology (ed. H.I. Maibach), pp. 56-66, Edinburgh, Churchill Livingstone, 1975.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The LLNA method was adopted in 2002.
Test material
- Reference substance name:
- A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene
- EC Number:
- 406-550-1
- EC Name:
- A mixture (1:2:1) of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene
- IUPAC Name:
- Reaction mass (1:2:1) of bis(N-cyclohexyl-N'-phenyleneureido)methylene and bis(N-octadecyl-N'-phenyleneureido)methylene and bis(N-dicyclohexyl-N'-phenyleneureido)methylene
- Details on test material:
- - Name of test material (as cited in study report): MDI/CHA/ODA/DCHA
- Description: White yellowish solid
- Storage condition of test material: At room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 10 weeks
- Weight at study initiation: 313 - 411 grams
- Housing: Group housing of 2 animals per cage with wire-mesh floors
- Diet: Free access to standard guinea pig diet, including ascorbic acid (LC 23-B, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands)
- Water: Free access to tap-water, diluted with decalcified water
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES (main study): From: August 27, 1990 To: September 27, 1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - 50% for the induction
- 25% for the challenge
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - 50% for the induction
- 25% for the challenge
- No. of animals per dose:
- Test animals: 20; Control: 10
- Details on study design:
- RANGE FINDING TESTS
One animal was treated epicutaneously at the shaved left flank with 0.5 mL of a 50% concentration of the test substance in corn oil using a Metalline patch (Lohman, Germany) mounted on Micropore tape (3M, USA) and held in place with Coban elastic bandage (3M, USA). After 24 hours, the dressings and residual test substance were removed using a tissue moistened with tap-water. The treated skin was assessed for erythema and oedema, 24 and 48 hours after bandage removal. Four further animals were shaved on the left flank and exposed to 0.05 mL of 50%, 25%, 10% and 5% (w/w) concentrations of the test substance in corn oil, occlusively administered by means of Square chambers (v.d. Bend, The Netherlands) mounted on Micropore tape. The bandage was fixed in place by means of Coban elastic bandage. After 24 hours, the dressings and residual test substance were removed using a tissue moistened with tap-water. The reaction sites were assessed for erythema and oedema, 24 and 48 hours after bandage removal. Immediately after the 24 hours skin reading, the treated areas were re-shaved.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9 applications during a period of 3 weeks (days 1, 3, 5, 8, 10, 12, 15, 17 and 19).
- Exposure period: 6 hours per application. After each application, the remaining test substance was also removed with a tissue moistened with tap-water.
- Test groups: 1
- Control groups: 1
- Site: scapula region (left side), after clipping
- Patch: Metalline (2 x 3 cm)
- Concentration: 50% in corn oil (test group); corn oil (control group) (0.5 mL)
- Scoring: The treated skin area of the test group and of the control group was scored immediately after removal of the dressings on day 19.
B. CHALLENGE EXPOSURE
- Day(s) of challenge: 10 days after the last induction (day 29)
- Exposure period: 6 hours. After the application, the remaining test substance was also removed with a tissue moistened with tap-water.
- Test groups: 1
- Control groups: 1
- Site: right flank, after clipping and shaving a 5 x 5 area.
- Patch: Metalline (2 x 3 cm)
- Concentrations (2 patches/animal):
-- 25% in corn oil (test and control group) (0.5 mL)
-- corn oil (test and control group) (0.5 mL)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings - Positive control substance(s):
- no
- Remarks:
- (a reliability check is carried out at regular intervals to check the sensitivity of the test system)
Results and discussion
- Positive control results:
- The latest reliability check was carried out in April 1990 using formaldehyde. In this study, a sensitisation rate of 35% was found, showing that the test system is reliable.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 9
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 6
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
RANGE FINDING TESTS
- In the animal treated with 0.5 mL of a 50% concentration, slight erythema was observed, 24 and 48 hours after bandage removal.
- In one other animal, treated with 0.05 mL of a 50% concentration, slight erythema was observed, 24 hours after bandage removal.
- No skin reactions were observed at 25, 10 and 5%.
- Based on these results, 50% was choosen for induction (highest concentration possible for a solid) and 25% for challenge (as erythema was observed at 50% and not at 25%).
MAIN STUDY
- Signs of irritation during induction: 1 animal of the test group
showed slight erythema and scaliness after the last application.
This animal subsequently indicated sensitisation. Scaliness was observed
in other animal during the induction period; this animal did not
subsequently indicated sensitisation.
- Six animals of the test group showed positive reactions. The positive reactions observed in the test group were characterised by spotted to confluent redness and scaliness.
- Vehicle group: No positive skin reactions after challenge
OTHER OBSERVATIONS
- No symptoms of systemic toxicity were observed in the animals
- One animal of the control group was found dead during the 1st induction application (day 1), possibly due to stress
- The average body weight gain of experimental and control animals was similar
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitising according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Based on the results of a Buehler test performed according to OECD 406 (1981), the substance needs to be classified as a skin sensitiser (sub-category 1B).
- Executive summary:
The skin sensitisation potential of the substance (a solid) was investigated by performing a Buehler test in accordance with OECD 406 (1981) and according to GLP principles. Corn oil was used as vehicle. Test substance concentrations selected for the main study were based on the results of a preliminary study. Reliable positive and negative controls were included.A concentration of 50% was used for the induction (max. attainable concentration) and 25% for the challenge. Six of the 20 test group animals showed sensitisation effects after challenge, resulting therefore in a sensitization rate of 30% in this non adjuvant-type test. As this is ≥15%, the substance needs to be classified as a skin sensitiser in accordance with the CLP Regulation (sub-category 1B).
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