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EC number: 280-479-2 | CAS number: 83547-95-9
- 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:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The optimization test as described by Maurer et al. (1975, 1980).
- Version / remarks:
- Maurer Th., Thomann P., Weirich E.G., Hess R. The Optimization test in the guinea pig. Agents & Actions 5 (2), 174-179. 1975.
Maurer Th., Weirich E.G. and Hess R. The Optimization test in the guinea pig in other predictive sensitization methods. Toxicology, 15, 163-171, 1980 - Deviations:
- not specified
- Principles of method if other than guideline:
- The optimization test was used, an intracutaneous sensitization procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of
Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). - GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- Study was conducted prior to REACH regulation.
Test material
- Reference substance name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
- EC Number:
- 280-479-2
- EC Name:
- 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide
- Cas Number:
- 83547-95-9
- Molecular formula:
- C30H57O7PS3
- IUPAC Name:
- 2-ethylhexyl 2-{[bis({2-[(2-ethylhexyl)oxy]-2-oxoethyl}sulfanyl)phosphoryl]sulfanyl}acetate
- Test material form:
- liquid
- Details on test material:
- - Other: Trade name D 16-051
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL (as described in study report): TK 12 184
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor / Batch No. 312-187
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: In house
- Weight at study initiation: 450 - 555 grams
- Housing: individually in Macrolon cages, type 3
- Diet: Standard guinea pig pellets - NAFAG, No. 830, Gossau SG, Switzerland
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + 2 deg C
- Humidity (%): 55 +10 %
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: propylene glycol 50% : saline 50% (week 1); mixture of saline with complete Bacto Adjuvant, 1 : 1 (weeks 2 and 3).
- Concentration / amount:
- 0.1%
- Day(s)/duration:
- 20 days - injections every other day (a total of 10 injections)
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- other: propylene glycol 50% / saline 50%
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- During week 6
- Adequacy of challenge:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 10%
- Day(s)/duration:
- During week 8
- Adequacy of challenge:
- other: a subirritant dose
- No. of animals per dose:
- 20
- Details on study design:
- Testing procedure
During the induction period the animals received injections every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 12 184 in propylene glycol 50 % / saline 50 %. One control group was treated with the vehicle alone ("negative control").
On the first day of week 1, two injections of 0.1 ml were administered into the shaven skin of the right flank and while on the following days a single intracutaneous injection was given into the flank.
During the second and third week of the induction period the test material was incorporated in a mixture of saline with complete Bacto Adjuvant (saline : adjuvant 1:1).
During week 6 a challenge injection of 0.1 ml of a freshly prepared 0.1 % solution of TK 12 184 in propylene glycol 50 % / saline 50 % was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
The two largest perpendicular diameters (in mm) and the increase in the skin- fold thickness (in mm) were measured and by multiplication of these values the "reaction volume" was obtained {in µ1) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergic reaction and the animal termed "positive". The number of "positive” animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control”).
During week 8 a subirritant dose (10 % TK 12 184 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The skin irritation was recorded according to Draize (described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959 of the US Association of Food and Drug Officials (AFDO) 24 hours after removal of the dressings. - Challenge controls:
- Treated with vehicle alone
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: intradermal
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Reading:
- other: epicutaneous
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: intradermal
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% concentration
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Reading:
- other: epicutaneous
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% concentration
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of this test, TK 12 184 is considered to possess skin-sensitizing (contact allergenic) potential in albino-guinea pigs.
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