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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
- Study period:
- 1990-10-30 to 1990-11-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A skin sensitization test according to OECD 406 has already excisted since 2000 and is sufficient for evaluation of the skin sensitisation potential of the test substance.
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:
- C10H15NO
- IUPAC Name:
- 3-cyano-3,5,5-trimethylcyclohexanone
- Details on test material:
- Isophorone nitrile of Degussa AG. Batch No. 64 II / 192 V / 89. Purity 99.8 % (GC).
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS:
- Strain: Dunkin-Hartley, Pirbright White (Bor: DHPW)
- Sex: male/female - Source: Winkelmann Versuchstierzuchten, Borchen (Germany)
- Age at study initiation: 10 weeks
- Weight at study initiation: males 489-565 g, females 453-535 g
- Number of animals: 5 males + 5 females
- Housing: single housing
- Diet: ad libitum, special diet for guinea pigs, SSniff G
- Water: ad libitum, tab water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 40 - 65 % (for short periods down to 30 %)
- Photoperiod (hrs dark / hrs light): 12 hours artificial light, 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: physiol. saline (intracutaneous) , paraffin oil (epicutaneous)
- Concentration / amount:
- 1st application: Induction 0.05 % intracutaneous
2nd application: Induction 30 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: physiol. saline (intracutaneous) , paraffin oil (epicutaneous)
- Concentration / amount:
- 1st application: Induction 0.05 % intracutaneous
2nd application: Induction 30 % occlusive epicutaneous
3rd application: Challenge 10 % occlusive epicutaneous
- No. of animals per dose:
- 10 test
5 control - Details on study design:
- - Controls: 5 males used for challenge + 5 females for rechallenge (not used)
ADMINISTRATION/EXPOSURE
- Preparation of test substance for induction: Dissolved in physiologic saline or suspended in paraffin oil
- Induction schedule:
Day 1: Injection (1st induction)
Day 7: Application of 10 % sodium dodecyl sulfate
Days 8-10: Patch treatment (2nd induction) of scapular area with test substance 30 % in paraffin oil (1 ml, 48 hours; control: paraffin oil)
- Injection details: 0.1 ml each at 6 positions in scapular area:
2 x Freund's Complete Adjuvant (FCA) / 0.9 % aqueous sodium chloride (= vehicle) (1:1)
2 x test substance 0.05 % in vehicle
2 x test substance 0.05 % in vehicle / FCA (1:1)
controls: vehicle instead of test substance
- Challenge schedule:
Days 22-23: Patch treatment (0.2 ml, 24 hours) with test substance 10 % in paraffin oil (left flank) and paraffin oil alone (right flank);
control: identical treatment
Days 24-25: Readings 24 and 48 hours after patch removal
- Rechallenge: not performed
- Positive control: p-phenylenediamine, performed Sept./Oct. 1989
EXAMINATIONS
- Grading system: Draize scores
- Pilot study: maximum non-irritating concentration (intradermal) and slightly to moderately irritating plus non-irritating concentrations (epidermal) - Challenge controls:
- treated with vehicle (Paraffin oil)
- Positive control substance(s):
- yes
- Remarks:
- p-phenylenediamine, performed Sep./Oct. 1989
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% preparation of test item in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10% preparation of test item in paraffin oil. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: see below.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% preparation of test item in paraffin oil
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% preparation of test item in paraffin oil. No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: see below.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10% preparation of test item in paraffin oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% preparation of test item in paraffin oil. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: see below.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% preparation of test item in paraffin oil
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- see below
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% preparation of test item in paraffin oil. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: see below.
Any other information on results incl. tables
RESULTS OF PILOT STUDY: The test substance was non-irritant to the skin.
RESULTS OF TEST
- Sensitization reaction:
erythema (all very slight, no edema) in 3/10 animals 24 hours and in 5/10 animals 48 hours after challenge patch removal
no animals positive in control group
no skin reaction upon vehicle treatment on opposite side (both groups)
- Clinical signs: Systemic effects could not be detected. The general condition and body weight development of the test animals
were not affected.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item Isophorone nitrile has sensitizing properties on the skin under conditions of this study.
- Executive summary:
Isophorone nitrile was applied to the skin of guinea pigs to determine its sensitizing properties by the maximization test method. The test substance was dissolved in physiologic saline or suspended in paraffin oil. Following epidermal challange 5/10 treated animals produced erythemas at the exposed skin areas. None of the control animals produced any visible reaction. Therefore isophorone nitrile has sensitizing properties on the skin of guinea pig.
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