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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-575-5 | CAS number: 1332-77-0
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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: Does not meet important study design or analytical criteria.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of boric acid on the generative function in males.
- Author:
- Tarasenko NY, Kasparov AA & Strongina OM
- Year:
- 1 972
- Bibliographic source:
- Gigiena Truda y Professionalnye Zabolevaniya 16 (11): 13 - 16.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of 12 male rats were exposed to aerosols of 9.6 ± 0.5mg/m3 and 48.6 ± 1.46mg/m3 boric acid for 4 hours/day for four months. When treatment was ended six males from the test and control groups were mixed (in separate cages) with an equal number of healthy oestrous females. Histological examinations of the testes were later performed.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP.
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 hours per day
- Frequency of treatment:
- Daily
- Duration of test:
- 4 months
Doses / concentrationsopen allclose all
- Dose / conc.:
- 9.6 mg/m³ air
- Remarks:
- aerosols of 9.6 ± 0.5 mg/m3
- Dose / conc.:
- 48.6 mg/m³ air
- Remarks:
- aerosols of 48.6 ± 1.46 mg/m3
- No. of animals per sex per dose:
- 12 males per group
- Control animals:
- yes
- Details on study design:
- Groups of 12 male rats were exposed to aerosols of 9.6 ± 0.5 mg/m3 and 48.6 ± 1.46mg/m3 boric acid for 4 hours/day for four months. When treatment was ended six males from the test and control groups were mixed (in separate cages) with an equal number of healthy oestrous females. After a single and double mating vaginal smears of females were examined for spermatozoa.
Results and discussion
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 9.6 mg/m³ air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Animals exposed to 9.6 ± 0.5 mg/m3 boric acid exhibited atrophied testis, reduced numbers and lifetime of spermatozoa, with pathological changes in the testis, including desquamation of the epithelium and necrotic cells.
Observed effects
Any other information on results incl. tables
There are a number of criticisms of this study, which prevent its use in the risk assessment of boric acid. Limitations were as follows:
1. No indication of the type of inhalation chamber is given. It was not clear as to whether exposure was to the whole body or nose only. There was no indication of aerosol size.
2. The methodology of investigation of the testis was not recognised.
3. There were no units given for spermatogenic index, nor for the numbers of spermatozoa. The term "lifetime" was not understood, and it was not clear what has been measured.
4. The histological criteria used in the table of morphological characteristics were not indicators that are normally used.
Applicant's summary and conclusion
- Conclusions:
- Animals exposed to 9.6 ± 0.5 mg/m3 boric acid exhibited atrophied testis, reduced numbers and lifetime of spermatozoa, with pathological changes in the testis. The effects were more severe in the 48.6 ± 1.46 mg/m3 dose group. However, there were a number of limitations relating to the methodology and reporting.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)