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EC number: 829-608-1 | CAS number: 106396-29-6
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2018-06-21 to 2018-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- EC Number:
- 829-608-1
- Cas Number:
- 106396-29-6
- Molecular formula:
- C29 H43 O4 P
- IUPAC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Purity: > 99%
Batch No.: 102Z4
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at arrival and 90 - 91 days at dosing
- Weight at study initiation: 2112.3-2486.1 g at dosing
- Housing: in stainless steel cages (W 70 cm × L 80 cm × H 75 cm)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 -7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Ultra-purified water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm × 2.5 cm
- Type of wrap if used: elastic bandage and medical paper tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test substance was gently wiped off the application site by cotton moistened with tepid water.
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
- Clinical Observations: once daily throughout the study
- Skin Reactions Examination: at approximate 1, 24, 48 and 72 hours after patches removal
- Body Weights: within 24 hours after arrival, on the day of dosing and on the completion of the final observations of dermal irritation symptoms
SCORING SYSTEM:
- Method of calculation: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- mean of three males
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- mean of three males
Any other information on results incl. tables
Inidividual skin reactions grading:
Animal ID | Skin reactions | 1 h | 24 h | 48 h | 72 h |
1100 | Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | |
1101 | Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema |
0 | 0 |
0 | 0 | |
1102 |
Erythema/Eschar | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to have no irritations to skin in rabbits.
- Executive summary:
The study was performed to assess the acute dermal irritation/corrosion of the test substance in Japanese White rabbits in accordance with OECD Guideline for the testing of chemicals: Acute Dermal Irritation/Corrosion (TG 404, adopted July 28, 2015).
Three male rabbits were used for the study. A quantity of 0.5 g test item was applied to the right side of back skin of each animal for an exposure period of 4 hours. The untreated skin on the left back area of the animal served as the control. Clinical signs were performed once daily throughout the study. The skin sites of each animal for signs of erythema/eschar and oedema were all recorded immediately, and at approximate 1, 24, 48 and 72 hours after patch removal, and all local toxic effects of skin were also fully described and recorded. Individual animal body weights were recorded on the day of dosing and on the completion of final observations of dermal irritation symptoms.
No abnormal signs or symptoms were observed in all animals throughout the course of the study. There were no observable abnormalities for three control sites in skin reaction examinations at all observation intervals after patches removal. There were no observable abnormalities for three test sites in skin reaction examinations at approximate 1, 24, 48 and 72 hours after patches removal of the test item. All animals showed expected gains in body weights during the course of the study.
Based on above results, the test substance was considered to have no irritations to skins in rabbits, and was classified as unclassified according to GHS's classification criteria for the skin irritation.
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