Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 403-830-5 | CAS number: 89331-94-2 B 290; BK 400; CK 34; DIBUTYL-N-102; DX-20; FAT NR. 40391/A; FLUORAN BLACK BD 869; FLUORAN SCHWARZ BD 869; NOIR FLUORANE BD 869; ODB-2; PSD-290; SENOR-2; TG-31; TH-108; WINCON-2
- 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:
- 16 February to 12 March 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An adequate and relevent in vivo study is available.
Test material
- Reference substance name:
- ODB-2
- IUPAC Name:
- ODB-2
- Reference substance name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- EC Number:
- 403-830-5
- EC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one
- Cas Number:
- 89331-94-2
- Molecular formula:
- C35 H36 N2 O3
- IUPAC Name:
- 6'-(dibutylamino)-3'-methyl-2'-(phenylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one
- Details on test material:
- - Name of test material (as cited in study report): ODB-2
- Substance type: Colour precursor for heat sensitive record sheets
- Physical state: White powder
- Analytical purity: > 99%
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: 61-24101
- Expiration date of the lot/batch: No data
- Stability under test conditions:
- Storage condition of test material: Ambient in the dark
- Other: date received 26 January 1988
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier
- Age at study initiation:
- Weight at study initiation: 460 - 536 g
- Housing: suspended cages with wire mesh floors
- Diet: Vitamin C-enriched guinea-pig diet F.D.1.,ad libitum. Hay was given weekly.
- Water: ad libitum
- Acclimation period: 19 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Humidity: 30 - 70%
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction
Intradermal injection: 0.05% w/w in Alembicol D.
Topical application: 50% w/w in Alembicol D.
Challenge
Topical application: 50% and 25% w/w in Alembicol D.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Alembicol D
- Concentration / amount:
- Induction
Intradermal injection: 0.05% w/w in Alembicol D.
Topical application: 50% w/w in Alembicol D.
Challenge
Topical application: 50% and 25% w/w in Alembicol D.
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
The intradermal and topical irritancy of a range of dilutions of ODB-2 was investigated to identify (a) irritant test substance concentrations suitable for the induction phase of the main study and (b) non-irritant concentrations by the topical route of administration for the challenge phase.
A concentration of 50% in AlembicolD was the maximum practical concentration that could be prepared and dosed topically. Based on the results of the preliminary investigations, the following concentrations of ODB-2 were selected:
Induction
Intradermal injection: 0.05% w/w in Alernbicol D.
Topical application: 50% w/w in Alernbicol D.
Challenge
Topical application: 50% and 25% w/w in Alernbicol D.
Alernbicol D is a product of coconut oil. By fractionating the fatty acids of coconut oil and re-esterifyinq with glycerine, a Medium Chain Triglyceride (MCT) Oil is produced. Alernbicol D is such an oil. It is advantageous in this type of test in that it is stable, has a low viscosity and surface tension and is easily absorbed into the skin. These properties made it ideal as a vehicle for intradermal injections and topical applications.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 1 week
- Test groups: 1
- Control group: yes, 10 animals
- Site: right and left dorsal
- Frequency of applications:
- Duration: two weeks
- Concentrations:
1. Freund's complete adjuvant* was diluted with an equal volume of water for irrigation.
2. ODB-2, 0.05% w/w in Alembicol D.
3. ODB-2, 0.05% w/w in a 50 : 50 mixture of Freund's complete adjuvant and Alembicol D.
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge:
- Exposure period: 3 days
- Test groups: 20 animals
- Control group: 10 animals
- Site: Shaved flanks.
- Concentrations: 0.2 ml of ODB-2, 50% w/w in Alembico1 D and applied to an anterior site on the flank. ODB-2, 25% w/w in Alembicol D was applied in a similar manner to a posterior site.
- Evaluation (hr after challenge): 24, 48 and 72 hours
OTHER: - Challenge controls:
- The test and control animals were challenged topically two weeks after the induction period using ODB-2, 50% and 25% w/w in Alembicol D.
- Positive control substance(s):
- yes
- Remarks:
- The sensitivity of the guinea-pig strain used is checked periodically at H.R.C. with formalin, a known sensitiser.
Results and discussion
- Positive control results:
- 1988; 10 animals tested all positive with formalin.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- ODB-2, 25% and 50%w/w in Alembicol D
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: ODB-2, 25% and 50%w/w in Alembicol D . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- ODB-2, 25% and 50% in Alembicol D.
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: ODB-2, 25% and 50% in Alembicol D.. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 10% formaldehyde aqueous solution (Formalin)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- not reported
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this screening test, performed in twenty albino guinea-pigs, ODB-2 did not produce evidence of delayed contact hypersensitivity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.