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EC number: 214-406-2 | CAS number: 1125-21-9
- 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:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 406 and EU Directive 92/69/EC. Study conducted under GLP.
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:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- EC Number:
- 214-406-2
- EC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Cas Number:
- 1125-21-9
- Molecular formula:
- C9H12O2
- IUPAC Name:
- 2,6,6-trimethylcyclohex-2-ene-1,4-dione
- Reference substance name:
- oxoisophoron
- IUPAC Name:
- oxoisophoron
- Reference substance name:
- 2,6,6-Trimethyl-2-cyclohexen-1,4-dion
- IUPAC Name:
- 2,6,6-Trimethyl-2-cyclohexen-1,4-dion
- Details on test material:
- - name of test substance: Oxoisophoron
- chemical name: 2,6,6-Trimethyl-2-cyclohexene-1,4-dion
- substance number: 96/87
- CAS number: 1125-21-9
- degree of purity/content: 98.87%
- date of manufacturing: 18-may-1995
- physical state/appearance: solid, yellow (at room temperature); liquid, yellowish (at 50 °C)
- storage conditions: room temperature
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River GmbH, Wiga, Kisslegg, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 339 - 400 g
- Housing: in group; Makrolon, type IV cage
- Diet (e.g. ad libitum): Kliba Labordiaet 341 (Kaninchen-Meerschweinchen-Haltungsdiaet) ad libitum
- Water (e.g. ad libitum): ad libitum; tap water; about 2 g of ascorbic acid per 10 L water was added to the drinking water twice aday.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: intradermal and percutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction:
Test substance 5% in olive oil DAB 10 or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or olive oil DAB 10
Percutaneous induction:
Test substnace 50% in olive oil DAB 10 or olive oil DAB 10
Challenge:
Test substance 25% in olive oil DAB 10 or olive oil DAb 10
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Intradermal induction:
Test substance 5% in olive oil DAB 10 or in Freund's adjuvant/0.9% aqueous NaCl-solution (1:1) or olive oil DAB 10
Percutaneous induction:
Test substnace 50% in olive oil DAB 10 or olive oil DAB 10
Challenge:
Test substance 25% in olive oil DAB 10 or olive oil DAb 10
- No. of animals per dose:
- control group: 5
test group: 10 - Details on study design:
- 1) Main test
Number of animals per control group: 5
Number of animals of the test group: 10
2) Induction
Intradermal induction:
- 6 intradermal injections in groups of twa per animal
Injections for the test group:
A) front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-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
Injections for control groups 1 and 2:
- The animals were given the same injections (A, B, C) but without test substance, only with the formulating agent.
Site of application:
- shoulder
Readings:
- 24 h after the beginning of application
Assessment of the skin findings:
- analogous to the pretest
Percutaneous induction:
- Percutaneous induction was carried out one week after intradermal induction.
Amount applied:
2 x 4 cm filter paper strips containing the test substance formulation were applied to the skin of the shoulder under an occlusive ciressing. The filter paper strip was soaked in the test substance formulation. The dressing consisted of rubberized linen patches (4 x 6 cm from Russka) and Fixomull® Stretch (adhesive fleece) from Beiersdorf AG. The control groups were treated analogously to the test group but only with the solvent without the test substance.
Duration of exposure:
- 48 hours
Site of application:
- shoulder, same area as in the case of the previous intradermal application
Readings:
- 48 h after the beginning of application
Assessment of skin findings:
-analogous to the pretest
3) Challenge
The challenge was performed 14 days after the percutaneous induction.
Amount applied:
2 x 2 cm filter paper strips containing the test substance formulation were applied to the skin of the flank under an occlusive dressing. The filter paper strip was soaked in the test substance formulation. The dressing consisted of rubberized linen patches (4 x 4 cm from Russka), patches of Idealbinde (5 x 5 cm from Pfälzische Verbandstoff-Fabrik) and Fixomull®D Stretch (adhesive fleece) from Beiersdorf AG.
-The test group and control group 1 were treated with the test substance formulation (control group 2 remained untreated).
Duration of exposure:
- 24 hours
Site of application:
- intact flank
Readings:
- 24 and 48 h after the removal of the patch
Assessment of skin findings:
- analogous to the pretest
4) Positive control
A positive control (reliability check) with a known sensitizer is not included in this study. However, a separate study is performed twice a year in the laboratory.
The positive control with Alpha-Hexylcinnamaldehyde techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory
conditions chosen. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Well-defined erythema in 3/10 (1 of these animals additionally with very slight edema); very slight erythema in 3/10.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Well-defined erythema in 3/10 (1 of these animals additionally with very slight edema); very slight erythema in 3/10..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- Very slight erythema in 4/10; well-defined erythema in 1/10.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: Very slight erythema in 4/10; well-defined erythema in 1/10..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle (olive oil DAB 10)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vehicle (olive oil DAB 10). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle (olive oil DAB 10)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vehicle (olive oil DAB 10). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of this study, the test substance 2,6,6-trimethylcyclohex-2-ene-1,4-dione / oxoisophoron has to be classified skin sens. Cat. 1 and R43 according to Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC, respectively.
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