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EC number: 946-014-9 | CAS number: -
- 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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Does not meet important study design or analytical criteria. 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:
- Effect of acute exposure to boric acid on the male reproductive system of the rat.
- Author:
- Linder RE, Strader LF & Rehnberg GL.
- Year:
- 1 990
- Bibliographic source:
- J. Toxicol. Environ. Health 31: 133 - 146.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not specified
- Principles of method if other than guideline:
- In a time-response study, groups of Sprague-Dawley adult male rats (6 rats per group) were exposed by gavage to boric acid at doses of 0 (control) and 2,000 mg boric acid/kg bw (the dose was administered in two volumes on the same day). These doses corresponded to 0 and 350 mg B/kg bw, respectively. Rats were killed at 2, 14, 28 and 57 days post-exposure.
In a second study, groups of Sprague-Dawley adult male rats (8 rats per group) were exposed by gavage to boric acid at doses of 0, 250, 500, 1,000 and 2,000 mg boric acid/kg bw (the dose was administered in two volumes on the same day). These doses correspond approximately to 0, 44, 88, 175 and 350 mg B/kg bw. All animals in the dose-response study were killed 14 days post exposure since this was identified as the interval at which maximum testicular damage was observed in the corresponding time-response study. - GLP compliance:
- no
- Type of method:
- in vivo
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
- Details on test material:
- - Name of test material: Boric acid.
- Analytical purity: 99 %
- Lot/batch No.: 95F-0275
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Raleigh, NC.
- Age at study initiation: 105 days
- Housing: Two per cage
- Acclimation period: 2 weeks
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 2 °C
- Humidity (%): 50 ± 10 % relative humidity
- Photoperiod (hrs dark / hrs light): 12h light/12 h dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- The boric acid solutions (5 % in water) were administered in a dose volume of 20 mL/kg. The solubility of boric acid in cold water is approxximately 5.6 % therefore 2000 mg/kg was maximum practical dosage that could be given as an aqueous solution on a single day.
Groups of 6 control and 6 boric acid-treated rats were killed at 2 and 14 day post-treatment. Four additional groups of 6 rats each were treated as described but killed at 28 and 57 d post-treatment. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Single dose divided into two volumes administered on the same day
- Frequency of treatment:
- Single dose divided into two volumes administered on the same day
- Duration of test:
- 57 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Study 1: 0 and 2000 (350) mg boric acid (mg B)/kg bw Study 2: 0, 250 (44), 500 (88), 1000 (175) and 2000 (350) mg boric acid (mg B)/kg bw.
Basis:
no data
- No. of animals per sex per dose:
- Study 1: 6 males
Study 2: 8 males - Control animals:
- yes
- Details on study design:
- Dose-response study: Unanaesthetised animals were decapitated and blood was collected for serum hormone assays. The testes, epididymides, prostate and seminal vesicles were excised and weighed. The ends (approximately 2 - 3 mm) of one testis were removed and this testis and the ipsilateral epididymis were immersed in Bouin's solution for 24 h then washed with 70 % ethanol saturated with lithin carbonat. Tissues were processed for light microscopy. The tissues were embedded in paraffin and transverse sections of hte testis and longitudinal sections of hte epididmysi were stained with hematoxylin and eosin, or periodic-Schff reagent and counterstained with hematoxylin. The contralateral testis was frozen for dtermination of sonication-resistant sperm heads. The contralateral epididymis was used for determination of cauda sperm motility, caput and cauda sperm morphology and caput and cauda sperm reserves.
- Statistics:
- Sperm counts, body weights and serum hormones were analysed by analysis of variance and Duncan's multiple range test. Organ weights were subjected to analysis of covariance using the final body weight as the covariant; equality of the group least-square means was compared with a t-test. Wilcoxon scores and Kruskal-Wallis test were used to evaluate sperm motility and sperm morphology.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 2 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Study 1: Sporadic but statistically significant differences (p < 0.05) in reproductive organ weights were noted when compared to controls.
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 350 mg/kg bw/day
- Based on:
- element
- Sex:
- male
- Basis for effect level:
- other: Study 1: Sporadic but statistically significant differences (p < 0.05) in reproductive organ weights were noted when compared to controls.
- Dose descriptor:
- NOAEL
- Effect level:
- 88 mg/kg bw/day
- Based on:
- element
- Sex:
- male
Observed effects
In the second study reported in the same publication, no effect on reproductive organ weights was observed at any exposure level when compared to controls. Histopathological changes in the testes as well as changes in sperm parameters consistent with the time-response study were observed in animals exposed to 1000 mg boric acid (175 mg B) and 2000 mg boric acid (350 mg B)/kg bw. No significant effect on serum hormones was found at any exposure level.
Applicant's summary and conclusion
- Conclusions:
- Aacute exposure to boric acid could adversely affect the testis (spermiation) and sperm quality in the adult male rat at dosages of 1000 mg boric acid (175 mg B)/kg bw and above. These effects were reversible at the dose level tested in the time response study (2000 mg boric acid (350 mg B)/kg bw) since by Day 57 post exposure, only minimal testicular changes remained. Based on the non-detection of the above effects, the authors concluded that the no observed effect level for acute exposure of the rat to boric acid was 500 mg boric acid (88 mg B)/kg.
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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