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EC number: 211-706-5 | CAS number: 688-74-4
- 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
Endpoint summary
Administrative data
Description of key information
Tributyl borate is rapidly hydrolyzed to Boric acid and n-Butanol in the presence of water or moisture in the air (18.3 sec at 21°C). Reliable endpoint information of the hydrolysis products n-Butanol and Boric acid is used, which is entirely appropriate to draw conclusions on the skin sensitisation potential of Tributyl borate:
- Hydrolysis product n-Butanol: not sensitising [in vivo study; OECD 429; mouse local lymphnode assay (LLNA)];
- Hydrolysis product Boric acid: not sensitising [in vivo study; OECD 406; Buehler test).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: experimental study on hydrolysis product Boric acid
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- OECD Guideline 406 "Skin Sensitisation" method (Buehler test ) was performed before the LLNA was set as preferred test method.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson’s Mill Farms, South Brunswick, NJ
- Age at study initiation: Young adult
- Weight at study initiation: Males: 314 -411 g; females: 282-376 g - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.4 g 95 % w/w boric acid
Challenge: 95 % w/w boric acid - No. of animals per dose:
- Test Group: 20 animals
Naive Control: 10 animals
Positive Control: 20 animals
Positive Naive Control: 10 animals - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Concentrations: 0.4 g 95 % w/w boric acid moistened with distilled water to enhance skin contact.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: Test substance was wiped off with water after 6 h. - Challenge controls:
- No data
- Positive control substance(s):
- yes
- Remarks:
- Dinitrochlorobenzene
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 34
- Group:
- test chemical
- Dose level:
- 0.4 g 95% w/w/boric acid
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 34.0. Group: test group. Dose level: 0.4 g 95% w/w/boric acid . No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Very faint erythema seen in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effect observed.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- OECD Guideline 406 "Skin Sensitisation" method (Buehler test ) was performed using 95 % w/w boric acid moistened with distilled water to enhance skin contact. Very faint erythema was observed in one animal at induction stage and 2 animals at challenge stage and also in one naïve control. No other adverse effects were observed therefore the test substance was considered a non-sensitiser.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- other: experimental study on hydrolysis product n-Butanol
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Indianapolis, IN or Jackson Laboratories, Bar Harbor, ME
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 6-12 weeks
- Housing, diet, water: Animals used in the study were housed, fed, and handled in compliance with standards set forth by the U.S. Animal Welfare Act and recommendations in the National Institutes of Health‘‘Guide for the Care and Use of Laboratory Animals’’ and all procedures performed on animals were reviewedand approved by a veterinarian and the Institutional Animal Care and Use Committee. - Vehicle:
- other: distilled water
- Concentration:
- 5%, 10% and 20% (v/v) in distilled water
- No. of animals per dose:
- 5
- Details on study design:
- - Groups of mice were treated 1x a day for 3 consecutive days on the dorsum of both ears with 25 µL of 1 of 3 concentrations of test material or with vehicle.
- 5 days after initial treatment, all mice were injected intravenously, via the tail vein, with 250 µL of phosphate buffered saline (PBS) containing 20 µCi of 3H-methylthymidine (3H-TdR; specific activity 5.0 Ci/mmol).
- 5 h later, mice were euthanised and draining auricular lymph nodes were removed and pooled for each individual mouse.
- Single cell suspensions were prepared by gentle mechanical disaggregation through nylon mesh (100 µm pore size).
- Cell suspensions were washed 2x with an excess of PBS and precipitated with 5% trichloroacetic acid (TCA) and left at 4°C overnight.
- Samples were then centrifuged, resuspended in 1 mL 5% TCA and transferred to 10 mL of scintillation cocktail (Ecolume, ICN Radiochemicals, Irvine, CA).
- 3H-TdR incorporation was measured by ß-scintillation counting and expressed as disintegrations per min (dpm) per individual mouse.
- Stimulation indices (SI) for each experimental group were determined as the increase in 3H-TdR incorporation relative to concurrent vehicle treated control group. Positive: a 3-fold or greater increase in proliferation, compared with the concurrent vehicle control, obtained at one or more test concentrations. - Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- vehicle water
- Key result
- Parameter:
- SI
- Value:
- 1.6
- Test group / Remarks:
- 5% (v/v)
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 10% (v/v)
- Key result
- Parameter:
- SI
- Value:
- 1.4
- Test group / Remarks:
- 20% (v/v)
- Cellular proliferation data / Observations:
- - vehicle water: 366 ± 44 mean dpm (± SEM)
- 5% (v/v) 1-butanol: 598 ± 157 mean dpm (± SEM)
- 10% (v/v) 1-butanol: 451 ± 17 mean dpm (± SEM)
- 20% (v/v) 1-butanol: 530 ± 91 mean dpm (± SEM) - Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- not sensitising (SI < 3 at all 3 concentrations tested)
- Executive summary:
The skin sensitization potential of 18 chemicals representing a variety of chemical classes was tested in the murine local lymph node assay (LLNA), whereby human data was used as the refernce for comaprison of the LLNA results.
11 of the tested materials are known to cause skin sensitization and 7 of which are believed not to be associated with any significant evidence of allergic contact dermatitis in humans. The LLNA correctly classified 16 of the 18 materials.
One of the correctly identified chemicals is Butan-1-ol that did not stimulate a SI of greater than 3 at all 3 concentrations tested [5%, 10% and 20% (v/v) in distilled water]. Accordingly, it can be concluded that Butan-1 -ol does not have the potential to cause skin sensitization.
Referenceopen allclose all
Observations:
Treatments |
Buehler test |
Observations/Remarks |
|
Day of treatment |
|
Induction 1 |
day 0 |
Very faint erythema (0.5) observed at one test site at 24 hours after first induction dose. No other irritation observed |
Induction 2 |
7 |
No irritation observed |
Induction 3 |
14 |
No irritation observed |
Challenge |
28 |
No irritation observed |
Scoring 1 |
29 |
Very faint erythema (0.5) observed at two test sites at 24 hours after challenge dose. Irritation persisted at one site for 48 hours. Very faint erythema (0.5) observed at one test site at 24 hours in one naive control. |
Scoring 2 |
30 |
|
Results of skin sensitisation test:
|
Number of animals with signs of allergic reactions / |
||
|
Negative control |
Test group |
Positive control |
scored after 24h |
0 / 10 |
0 / 20 |
10/20 |
scored after 48h |
0 / 10 |
0 / 20 |
7/20 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Tributyl borate is not classified as a skin sensitiser according to Regulation (EC) No 1272/2008, because there is no evidence for a skin sensitising mode of action on the related hydrolysis products n-Butanol and Boric acid.
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.
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