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EC number: 686-800-6 | CAS number: 12008-39-8
- 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
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Meets generally accepted scientific standards with acceptable restrictions. This study is conducted on an analogue substance. Read-across is justified on the following basis: In aqueous solutions at physiological and acidic pH, low concentrations of simple inorganic borates such as boric acid, disodium tetraborate decahydrate, disodium tetraborate pentahydrate, boric oxide and disodium octaborate tetrahydrate will predominantly exist as undissociated boric acid. At about pH 10 the metaborate anion (B(OH)4-) becomes the main species in solution (WHO, 1998). This leads to the conclusion that the main species in the plasma of mammals and in the environment is un-dissociated boric acid. Since other borates dissociate to form boric acid in aqueous solutions, they too can be considered to exist as un-dissociated boric acid under the same conditions. For comparative purposes, exposures to borates are often expressed in terms of boron (B) equivalents based on the fraction of boron in the source substance on a molecular weight basis. Some studies express dose in terms of B, whereas other studies express the dose in units of boric acid. Since the systemic effects and some of the local effects can be traced back to boric acid, results from one substance can be transferred to also evaluate the another substance on the basis of boron equivalents. Therefore data obtained from studies with these borates can be read across in the human health assessment for each individual substance. Conversion factors are given in the table below. Conversion factor for equivalent dose of B Boric acid H3BO3 0.175 Boric Oxide B2O3 0.311 Disodium tetraborate anhydrous Na2B4O7 0.215 Disodium tetraborate pentahydrate Na2B4O7•5H2O 0.148 Disodium tetraborate decahydrate Na2B4O7•10H2O 0.113 Disodium octaborate tetrahydrate Na2B8O13•4H2O 0.210 Sodium metaborate (anhydrous) NaBO2 0.1643 Sodium metaborate (dihydrate) NaBO2•2H2O 0.1062 Sodium metaborate (tetrahydrate) NaBO2•4H2O 0.0784 Sodium pentaborate (anhydrous) NaB5O8 0.2636 Sodium pentaborate (pentahydrate) NaB5O8∙5H2O 0.1832 References: WHO. Guidelines for drinking-water quality, Addendum to Volume 1, 1998.
Data source
Reference
- Reference Type:
- publication
- Title:
- The ototoxic effect of boric acid solutions applied into the middle ear of guinea pigs.
- Author:
- Öztürkcan S, Dündar R, Katilmiş H, İlknur AE, Aktaş S & Haciömeroğlu S.
- Year:
- 2 009
- Bibliographic source:
- Eur. Arch. Otorhinolaryngol. 266: 663 - 667.
Materials and methods
- Type of study / information:
- The study analysed the ototoxic effects of boric acid solutions on 22 young guinea pigs.
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not specified
- Principles of method if other than guideline:
- The study analysed the ototoxic effects of boric acid solutions on 22 young guinea pigs. Auditory Brainstem Response (ABR) test was applied prior to adminsitration. A perforation was created on the tympanic membrane of the right ear and small gelfoam pieces were inserted into the perforation. Test solutions were administered for 10 days by means of a transcanal route. 15 days after insertion of the gelfoams they were removed and the ABR repeated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- H3BO3
- IUPAC Name:
- Boric acid
Constituent 1
Results and discussion
Any other information on results incl. tables
When the saline control group and the 4 % boric acid solution prepared with distilled water group were compared against the initial condition of both groups, a borderline significance was detected (P = 0.046; P = 0.046, respectively). When the ototoxic control (Gentamicine) and 4 % boric acid solution prepared with 70 % alcohol groups were compared against their initial conditions, statistically signifcant changes in the ABRs threshold was found (P = 0.026; P = 0.011, repectively). When the ototoxic control group was compared with the 4 % boric acid solution prepared with distilled water and with the saline group, a statistically significant toxic effect was found in the ototoxic control group ( P = 0.003; P = 0.001, respectively). When the Gentamicine group was compared with 4 % boric acid solution prepared with 70 % alcohol group, no significant difference in ototoxic effect was detected between the two groups (p = 0.128).
As a result of the comparison of the 4 % boric acid solution prepared with 70 % alcohol group with the saline group and the 4 % boric acid prepared with distilled water groups statistically significant effect in the 4 % boric acid solution prepared with 70 % alcohol was detected (P = 0.002 ; P = 0.000). No statistically significance was found in comparison of the saline and 4 % boric acid solution prepared with distilled water groups (P: 0.653). In the group where 4 % boric acid solutions prepared with 70 % alcohol statistically significant alterations in the test thresholds were detected.
Applicant's summary and conclusion
- Conclusions:
- The study analysed the ototoxic effects of boric acid solutions on 22 young guinea pigs. Prior to application of the boric acid solution under general anaesthesia an Auditory Brainstem Response (ABR) test was applied to the right ear of the guinea pigs. Following the test a performation was created on the tympanic membrane of the right ear of each guinea pig and small gelfoam pieces inserted into the perforated area. Test soluitons were administered to the middle ear for 10 days by means of a transcanal route. 15 days after inserting the gelfoams they were removed and the ABR test performed again. The ABRs were within the normal range before applications after hte application no singificant changes were deteced in the ABRs threshold in the saline group or the group administered boric acid and dstilled water solution. However, significant changes were detected in the ototoxic control group (Gentamicine) and boric acid and alcohol solution groups.
Read-across is justified on the basis detailed in the rationale for reliability above. This study is therefore considered to be of sufficient adequacy and reliability to be used as a supporting study and no further testing is justified.
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