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EC number: 403-960-2 | CAS number: 126877-05-2 C.I. DISPERSE RED 367
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- method of Magnusson and Kligman (1970)
- Principles of method if other than guideline:
- see attached file
- GLP compliance:
- yes
- Type of study:
- other: The sensitising properties of the test sample were asse.ssed using the maximisation test of Magnusson and Kligman (1970).
Test material
- Reference substance name:
- 2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate
- EC Number:
- 403-960-2
- EC Name:
- 2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate
- Cas Number:
- 126877-05-2
- Molecular formula:
- C28H22O8
- IUPAC Name:
- 2-ethoxyethyl 2-(4-{5,11-dioxo-12-phenyl-4,10-dioxatricyclo[7.3.0.0³,⁷]dodeca-1(12),2,6,8-tetraen-6-yl}phenoxy)acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Substance HI07597
- Sample reference: NBW 8809/52
- Physical state: red powder
- Purity: 100% (w/w)
- Moisture: <0.2%
- CTL reference number: Y04203/002/001
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Barriered Animal Breeding Unit, ICI Pharmaceuticals, Alderley Park, Macclesfield, Gheshire, UK
- Age at study initiation: young adults
- Weight at study initiation: 279-369g
- Weight at positive control study initiation: 262-385g
- Housing: housed individually in suspended cages (37cm length x 32cm width x 20cm height)
- Diet (e.g. ad libitum): free access to food (Labsure RGP Guinea Pig Diet)
- Water (e.g. ad libitum): unl imited access to water vi a an automatic system.
- Acclimation period: minimum of six days prior to the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 ± 2°C
- Humidity (%): 50 ± 10%
- Air changes (per hr): 20-30 air-changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light and 12 hours of darkness.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- See "Details on study design" section.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- See "Details on study design" section.
- No. of animals per dose:
- A group of thirty female guinea pigs was used for the main study, twenty test and ten control.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Before exposure :
A row of three injections (0.05-0.1mL each) was made on each side of the mid-line. The injections were:
(i)Top: Freund's Complete Adjuvant plus 3% DMF in corn oil in the ratio 1:1 ;
(ii) Middle: a 1% (w/v) preparation of the test sample in 3% OMF in corn oil ;
(iii) Bottom: a 1% (w/v) preparation of the test sample ina 1:1 preparation of Freund's Complete Adjuvant plus 3% DMF in corn oil.
The injections were checked for any adverse effects for up to 48 hours.
One week later, the scapular area was clipped again and treated as decribed below :
- No. of exposures: 1
- Exposure period: 48 hours.
- Control group: yes with topical application with corn oil only
- Site: scapular area
- Concentrations: application of 0.25g of 75% (w/v) preparation in corn oil
- Observations: 24 hrs after removal of the dressing.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 hrs
- Site: on one or both flanks of all the test and control animals
- Concentrations: A 75% (w/v) preparation of the test sample (approximately 0.13g) was applied to one of the pieces of filter paper and 0.05-0.1ml of a 30% (w/v) preparation in corn oil was applied to the second piece of filter paper. The dressing was placed onto the guinea pig so that the 75% (w/v) preparation was on the right shorn flank and the 30% (w/v) preparation was on the left shorn flank.
- Evaluation (hr after challenge): 24 and 48hrs - Positive control substance(s):
- yes
- Remarks:
- Formaldehyde (40% (w/v) solution in water)
Results and discussion
Any other information on results incl. tables
The substance was assessed for its skin sensitisation potential using the method of Magnusson and Kligman (1970) . Challenge with the test sample caused staining which obscured all application sites. Histopathological examination of the challenge sites revealed that 30% and 75% (w/v) preparations of test substance in corn oil had elicited a skin sensitisation response. In a positive control study, under similar conditions, formaldehyde elicited an extreme sensitisation response in previously-induced guinea pigs .
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Magnusson B al1ld Kl igman A M (1970)
- Conclusions:
- Histopathological examination of the challenge sites revealed that 30% and 75% (w/v) preparations of the Substance had elicited a skin
sensitisation response. - Executive summary:
sensitising
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