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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 616-639-9 | CAS number: 78620-07-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: conducted to OECD/EC guidelines with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Details on test material:
- - Name of test material (as cited in study report): Belcor 575 trisodium salt (TK13061/2)
- Physical state: Aqueous solution
- Aqueous sodium salt solution formed by neutralising acid with sodium hydroxide (52% Belcor 575, 48% NaOH)
- Lot/batch No.: PAD-A-240-226-D
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Ltd, Tierfarm
- Age at study initiation: approximately 10 weeks old.
- Weight at study initiation: 363 - 455 grams
- Housing: Macrolon cages, type 3
- Diet (e.g. ad libitum): ad libitum guinea pig pellets (NAFAG No. 845, Gossau SG)
- Water (e.g. ad libitum): ad libitum fresh water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- First induction week, intradermal application : 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%].
Second inductionweek, epidermal aplication: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
Challenge: 0.2g paste of TK13061/2 incorporated in vaseline (w/w) [test material concentration 3%].
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- petrolatum
- Concentration / amount:
- First induction week, intradermal application : 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%].
Second inductionweek, epidermal aplication: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
Challenge: 0.2g paste of TK13061/2 incorporated in vaseline (w/w) [test material concentration 3%].
- No. of animals per dose:
- 20 animals (male/female) in test group and 20 animals (male/female) in control group.
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: Intradermal injection followed by a closed patch exposure over injection site one week later.
- Test groups: 0.1 ml of one of three preparations (adjuvant/saline mixture 1:1 (v/v); test article TK13061/2 in physiological saline (w/v); test article TK13061/2 in the adjuvant saline mixture (w/v). - [test material concentration 5%]. Second induction: 0.4g paste of TK13061/2 incorporated in vaseline (w/w) [Test material concentration 10%].
- Control group: treated with adjuvant and vehicle only.
- Site: neck region
- Duration: 1x injection and 1x patch
- Concentrations: 5% test material for injection; 10% test material for epidermal application.
B. CHALLENGE EXPOSURE
- Exposure period: 24 hours
- Test groups: 0.2g of TK13061/2 in vaseline (w/w)
- Control group: treated with the vehicle as well as the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
- Site: Flank
- Concentrations: 0.2g of TK13061/2 in vaseline (w/w) (concentration of test material 3%).
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 10.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- 50% of the animals were sensitized by TK13061/2. According to the maximization grading, TK13061/2 showed a moderate grade of skin sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
In a dermal sensitization study twenty 10 week old male and female pirbright white guinea pigs with Trisodium [carboxy(oxido)methyl]phosphonate in petrolatum, were tested using the method of guinea pig maximisation test.
In this study, trisodium [carboxy(oxido)methyl]phosphonate is a moderate dermal sensitizer.
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.
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