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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2018-06-21 to 2018-06-28
- 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2017
- 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 / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Limited Company
- Age at study initiation: 84 days at receipt and 90 - 94 days at dosing
- Weight at study initiation: 1899.2 - 2009.1 g at receipt and 2233.4 - 2257.5 g at dosing
- Housing: in stainless wire 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 – 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.2 - 20.9 °C
- Humidity (%): 47% - 72%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 72 hours
- Details on study design:
- TOOL USED TO ASSESS SCORE: binocular loupe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Remarks on result:
- probability of weak irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively. The maximum values of animals No. 1100 and 1102 are 1, 1.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- The mean values of the three animals are 0, 0, 0, respectively.
- Other effects:
- - Clinical Observations: No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing.
- Eye Examination: There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration.
- Fluorescein Examination: There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing.
- Body Weights: All animals showed expected gains in body weights during the study.
Any other information on results incl. tables
Eye reaction scoring:
Animal ID | Eye reactions | 1 h | 24 h | 48 h | 72 h |
1100 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 1 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 | |
1101 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 0 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 | |
1102 | Cornea | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | |
Conjunctivae Redness | 1 | 0 | 0 | 0 | |
Conjunctivae Chemosis | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test subatnce could produce very slight eye irritant reactions in rabbit.
- Executive summary:
The study was performed to assess the acute eye irritation/corrosion of the test substance in Japanese White rabbits in accordance with the OECD Guideline for the testing of chemicals: Acute Eye Irritation/Corrosion (TG 405, adopted October 9, 2017).
Three male rabbits were used for the study. Each animal was administered with 0.1 g of the test item into the right eye. Untreated left eye served as the control. Immediately after administration of the test item, the initial reaction was observed and recorded. Test animals were routinely observed and recorded for clinical signs of pain and/or distress and any adverse systemic effects except eye twice daily for 3 days after administration of the test item, with a minimum of 6 hours between observations. Both eyes of animals were examined by a binocular loupe at approximate 1, 24, 48 and 72 hours after administration. The ocular reactions and any other lesions in the eye were recorded at each examination. Fluorescein stain examination was used at approximate 24 hours after administration. Ocular lesions (cornea, iris, conjunctivae redness and chemosis) for treated eye of each animal were scored and recorded at each examination. Mean scores of ocular lesions at approximate 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded on the day of dosing and the completion of the final symptom observations of eye irritation.
No significant adverse systemic effect was observed in any animal during the study. The animals only showed excessive blinking at immediate observations after dosing. There were no abnormalities for all eyes in eye examinations approximately 24 hours prior to dosing. There were no observable abnormalities in eye examinations for three control eyes at all observation intervals after administrations. The treated eyes of animal No. 1100 and 1102 showed some blood vessels hyperaemic (injected) at 1 hour after administration. All treated eyes showed no eye irritant reactions at 24, 48 and 72 hours after administration. There was no retention of fluorescein for three control and treated eyes at 24 hours before and after dosing. Body Weights: All animals showed expected gains in body weights during the study.
Based on above results, the test substance could produce very slight eye irritant reactions in rabbit, and was classified as unclassified according to GHS's classification criteria for the eye irritation.
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.