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EC number: 411-490-4 | CAS number: 7027-11-4 ISOPHORONENITRILE, IPN
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.6
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- EC Number:
- 411-490-4
- EC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Cas Number:
- 7027-11-4
- Molecular formula:
- C10 H15 N O
- IUPAC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Details on test material:
- - Lot No.: 22298/133
- Purity: > 99.5%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 267-317 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 0.1 ml of 1% formulation in olive oil
Percutaneous induction: 0.3 g (as 75% formulation in olive oil)
Challenge: 0.15 g (as 50% formulation in olive oil)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction: 0.1 ml of 1% formulation in olive oil
Percutaneous induction: 0.3 g (as 75% formulation in olive oil)
Challenge: 0.15 g (as 50% formulation in olive oil)
- No. of animals per dose:
- Control group: 5
Test group: 10 - Details on study design:
- RANGE FINDING TESTS:
Amount applied:
2 x 2 cm filter paper strips were applied to the skin of the flanks under an occlusive dressing (the bandage consists of rubberized linen patches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the test filter paper strip was soaked in the test substance resp. test substance formulation; thus, the animals were exposed to about 0.15 g of the test substance resp. test substance formulation.
Exposure period:
The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold.
Site of application:
- flank, respective on the same area
Number of test animals:
- 4 per test concentration
Readings:
- about 24 and 48 h after the beginning of application
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal:
- No. of exposures: 2
- Test groups: 1: A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9%aqueous NaC1-solution in a ratio of 1:1 B) middle row: 2 .injections each of 0.1 ml of the test substance formulation C) back row: 2 injections each of 0.1 ml Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1) with test substance
- Control groups: 2: The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
- Site: Shoulder
- Frequency of applications: once
- Duration: 7 days (reading after 24 h)
- Concentrations: 0.1 ml of 1% formulation in olive oil
Percutan
- No of exposures: 1
- Test group: 2 x 4 cm filter paper strips were applied to the skin of the shoulder under an occlusive dressing (the bandage consists of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). The filter paper strip was soaked in the test substance formulation; thus, the animals were exposed to about 0.3 g of the test substance formulation.
- Control groups: The control groups were treated analogously to the test group but only with the solvent without the test substance.
- Site: Shoulder
- Frequency of application: once
- Duration: 48 h
-Concentration: 0.3 g (as 75% formulation in olive oil)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21 (after intradermal induction)
- Exposure period: 24 h
- Test groups: 2 x 2 cm filter paper strips were applied to the skin of the flank under an occlusive dressing the bandage consists of rubberized linenpatches 4 x 4 cm from Russka and Fixomull Stretch (adhesive fleece) from Beiersdorf AG). In the case of liquids the test filter paper strip was soaked in the test substance formulation; thus the animals were exposed to about 0.15 g of the test substance formulation.
- Control group: treatment of the test group and of control group 1 with the test substance formulation. Additionally olive oil DAB 9 was applied as a vehicle. Control group 2 only received olive oil DAB 9.
- Site: flank
- Concentrations: 0.15 g (as 50% formulation in olive oil)
- Evaluation (hr after challenge): 24 and 48 h after removal of the patch
OTHER: - Challenge controls:
- yes, (control group 2)
- Positive control substance(s):
- yes
- Remarks:
- 1-chlor-2,4-dinitro-benzol
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.15 g (as 50% formulation in olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.15 g (as 50% formulation in olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.15 g (as 50% formulation in olive oil)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.15 g (as 50% formulation in olive oil). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Negative control group 1
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Negative control group 1
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 1. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Negative control group 2
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Negative control group 2
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Negative control group 2. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- edema and erythema of varying degree
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: edema and erythema of varying degree.
Applicant's summary and conclusion
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