Registration Dossier
Registration Dossier
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: 201-122-9 | CAS number: 78-51-3
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Short report of guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Method: other: CFR Part 191.1, Chapter 1, Title 21
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Route of administration:
- oral: gavage
- Doses:
- 2150 and 4640 mg/kg bw
- No. of animals per sex per dose:
- 5
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 640 mg/kg bw
- Interpretation of results:
- Category 5 based on GHS criteria
There were no deaths among the rats exposed to test material at 2150 mg/kg bodyweight. At 4640 mg/kg bwt 3/5 rats died. No clinical signs were reported in rats exposed to 2150mg/kg bwt. No abnormalities were noted in survivors at necropsy.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well reported study; in line with OECD 405/EC B5
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Method: other: Code of Federal Regulations Part 191.12, Chap.1, Title 21
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Number of animals or in vitro replicates:
- 6
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TBEP is not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
Three of six rabbits showed no signs of irritation. Three rabbits exhibited moderate conjunctival erythema and iritis which resolved within 48-h.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Draize Test
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- no
Test material
- Reference substance name:
- Tris(2-butoxyethyl) phosphate
- EC Number:
- 201-122-9
- EC Name:
- Tris(2-butoxyethyl) phosphate
- Cas Number:
- 78-51-3
- Molecular formula:
- C18H39O7P
- IUPAC Name:
- tris(2-butoxyethyl) phosphate
- Details on test material:
- Phosflex T-BEP
Constituent 1
Test animals
- Species:
- rabbit
Test system
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- 24/48/72 h
- Score:
- 3.17
- Remarks on result:
- other: observation at 24h and 72h
- Irritation parameter:
- other: PDII for intact sites only
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 1.42
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: obseravtion at 24h and 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.57
- Max. score:
- 4
- Remarks on result:
- other: abraded skin
- Remarks:
- observation at 24h and 72h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.09
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- observation at 24h and 72h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Remarks on result:
- other: intact skin
- Remarks:
- observation at 24h and 72h
Any other information on results incl. tables
Erythema was more severe in abraded than intact sites at both 24 and 72-h. There was only a single rabbit (female) with oedema of an intact site (score 1) at 72-h. All abraded sites were scored for oedema at 24-h (mean score = 2); 2/6 abraded sites had resolved by 72-h - mean oedema score at 72-h was 1.13. The aggregate score for erythema at 24 and 72-h were 1.66 and 1.0 respectively for the intact sites. The mean scores for oedema of intact sites at 24 and 72-h were: 0 and 0.17 respectively.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- TBEP was considered a moderate irritant by US FDA criteria. However, from the lower scores recorded at intact sItes than abraded site, TBEP would not be classified for skin irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
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.
