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EC number: 817-187-7 | CAS number: 1803088-15-4
- 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:
- 2016-06-08 to 2016-09-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, as this is in line with OECD 404
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one
- EC Number:
- 817-187-7
- Cas Number:
- 1803088-15-4
- Molecular formula:
- C54 H73 O5 P
- IUPAC Name:
- 5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one
- Details on test material:
- - State of aggregation: Solid / white
- Storage Condition: room temperature under light exclusion
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; under light exclusion ; no direct sunlight
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo CRS (Switzerland) Limited
- Age at study initiation: approx. 7-9 months
- Weight at study initiation: 3.70 - 4.51 kg
- Housing: individual housing
- Diet: STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: approx. 10 per hr
- Photoperiod: 12 /12 hrs dark / hrs light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g was loaded on the test patch (2.5 x 2.5 cm) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- Type of wrap if used: The item was covered with a test patch and adhesive fleece
REMOVAL OF TEST SUBSTANCE
- Washing: The test item was removed at the end of the exposure period with polyethylenglycol
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
Immediately after removal of the patch, approx. 1, 24, 48, 72 h after removal of the patch
SCORING SYSTEM: Evaluation of skin reactions was performed according to the quoted guidelines.
- Method of calculation: For evaluation mean values of erythema and edema were calculated based on readings at 24, 48, 72 h. Calculations were performed using Microsoft Excel 2010 and checked with a calculator.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight erythema (grade 1) was observed in two animals immediately after removal of the patch and persisted until hour 1 or hour 24. The third animal was free of any findings. The cutaneous reactions were reversible in two animals within 24 or 48 hours after removal of the patch.
- Other effects:
- - Other adverse local effects: none
- Other adverse systemic effects: none
Any other information on results incl. tables
Table 1. Tabulation of irritant response data for each individual animal at each observation time as well as calculation of the means
Readings |
Animal No. |
Erythema |
Edema |
0 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
1 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
1 |
0 |
|
24 h |
1 |
1 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
48 h |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
72 h* |
1 |
0 |
0 |
2 |
0 |
0 |
|
3 |
0 |
0 |
|
Mean 24 h – 72 h |
1 |
0.3 |
0.0 |
2 |
0.0 |
0.0 |
|
3 |
0.0 |
0.0 |
|
Mean |
- |
0.1 |
0.0 |
*Study discontinued because the animals were free of findings
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the described cutaneous reactions as well as the average score for irritation, the test item does not show a skin irritating potential under the test conditions chosen.
- Executive summary:
The potential of the test item to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 g of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch. The following test item-related clinical observations were recorded during the course of the study: Very slight erythema (grade 1). The cutaneous reactions were reversible in two animals within 24 or 48 hours after removal of the patch. The third animal did not show any findings. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions as well as the average score for irritation, the test article does not show a skin irritating potential under the test conditions chosen.
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