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EC number: 948-058-4 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to a guideline study. 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:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
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: > 99.7 %
- stability: Stable
- Lot/batch No.: 872703
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products Inc., Denver, PA, USA
- Age at study initiation: 5 months of age
- Weight at study initiation: 2690-4380 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 55 mg/mL boric acid
- Amount of vehicle: 5 mg/mL boric acid - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Details on mating procedure:
- - Impregnation procedure: Artificial insemination; designated Day 0
- Duration of treatment / exposure:
- Groups of 30 rabbits were used treated on Day 6 - 19 post-mating
- Frequency of treatment:
- No data
- Duration of test:
- Terminated on Day 30 of gestation
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 62.5, 125 or 250 mg/kg bw boric acid equivalent to 0, 10.9, 21.8 and 43.5 mg B/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 30 females/group
- Control animals:
- yes
- Details on study design:
- No data
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 30
- Organs examined: Uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: No data
- Number of late resorptions: No data
- Other:
Uteri were stained with ammonium sulphide as no implantations were visible.
Litter size, number of dead foetuses and foetal weight were assessed. - Fetal examinations:
- - External examinations: Yes, including assessment for cleft palate
- Soft tissue examinations: Yes by dissection (Staples) and sex determined
- Skeletal examinations: Yes, all foetuses were skinned and cleaned and stained with alcian blue/alizarin red S
- Head examinations: Yes - Statistics:
- No data
- Indices:
- No data
- Historical control data:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Pregnant does exhibited no overt symptoms attributable to boric acid toxicity except in the high dose group. A decreased food intake (30 % reduction vs. controls during exposure period) and decreased maternal bodyweight were observed. Vaginal bleeding was noted at 43.5 mg B/kg bw between gestational days 19 - 30. All high-dose animals with vaginal bleeding had no live foetuses at sacrifice. At mid dose, increased body weight gain not clearly adverse. The authors considered 43.5 mg B/kg bw as the LOAEL for pregnant does and 21.8 mg B/kg bw as the NOAEL for maternal toxicity.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 43.5 mg/kg bw/day
- Based on:
- element
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 21.8 mg/kg bw/day
- Based on:
- element
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 43.5 mg/kg bw/day
- Based on:
- element
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 21.8 mg/kg bw/day
- Based on:
- element
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
At the highest dose in this study of 250 mg/kg bw boric acid (43.5 mg B/kg bw/day), 90 % of implants/litter were resorbed compared to 6 % for controls, and 73 % had complete litter loss (0 % in controls). In the mid and low dose groups, no difference in percentage resorptions per litter was seen, compared to controls.
Average foetal bodyweight per litter was 92 % of the controls at the high dose (43.5-mg B/kg bw) but even at this exposure, it did not reach statistical significance possibly due to the low number of pups surviving (14 fetuses from 6 litters).
An increased incidence of malformed live foetuses/litter was observed at 43.5 mg B/kg bw, primarily due to cardiovascular defects (72 % for major defects of heart and/or great vessel in the high-dose group vs. 3 % in controls). In the mid and low dose groups, there was no increase in malformations per litter or total malformations. There were no variations between any groups concerning the incidence of skeletal malformations.
The only skeletal variations of interest was a dose related reduction in the incidence of extra ribs on Lumbar I which the authors did not consider to be toxicologically important.
Since no definitive developmental effects were observed in animals exposed to either 62.5 or 125 mg/kg bw boric acid (10.9 or 21.8 mg B/kg bw/day), the authors concluded that 125 mg/kg boric acid per day (21.8 mg B/kg bw/day) was the NOAEL for developmental toxicity.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 21.8 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: Since no definitive developmental effects were observed in animals exposed to 62.5 or 125 mg/kg bw boric acid (10.9 or 21.8 mg B/kg bw/day), it is concluded that 125 mg/kg boric acid per day (21.8 mg B/kg bw/day) was the NOAEL for developmental toxicity.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 125 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Since no definitive developmental effects were observed in animals exposed to 62.5 or 125 mg/kg bw boric acid (10.9 or 21.8 mg B/kg bw/day), it is concluded that 125 mg/kg boric acid per day (21.8 mg B/kg bw/day) was the NOAEL for developmental toxicity.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Maternal effects
Parameter |
Study control data |
Low dose |
Medium dose |
High dose |
Number of dams examined |
30 |
30 |
30 |
30 |
Clinical findings during application of test substance |
|
|
|
reduced food and bodyweight |
Mortality of dams (%) |
0 |
1 |
1 |
0 |
Abortions |
0 |
0 |
0 |
3 |
Body weight gain day 6-19 day 0-30 |
93 357 |
132 493 |
97 543 |
-137* 226 |
Food consumption g/kg/day day 0-6 day 6-19 day 19-25 |
48.1 38.8 36.9 |
48.0 40.0 37.0 |
48.9 38.7 40.0 |
46.4 26.6* 44.9 |
Pregnancies % pregnant at sacrifice |
75 |
89 |
87 |
96 |
Necropsy findings in dams dead before end of test |
|
gavage error lungs |
stomach damage |
|
* P < 0.05.
Litter response (Caesarean section data)
Parameter |
Control data |
Low dose |
Medium dose |
High dose |
Corpora lutea number ±SEM mean No. per dam |
12.2 0.7 |
10.7 0.5 |
11.5 0.4 |
10.0* 0.7 |
Implantations sites per litter number ±SEM total/number of dams |
9.5 0.8 |
8.4 0.6 |
8.3 0.5 |
8.6 0.7 |
Resorptions % per litter % total/number of dams ±SEM |
6.3 2.4 |
5.9 1.9 |
7.7 2.1 |
89.9 5.0 |
total number of foetuses |
159 |
175 |
153 |
14 |
total number of litters |
18 |
23 |
20 |
6 |
live foetuses / litter number state ratio ±SEM |
8.8 0.8 |
7.6 0.6 |
7.7 0.5 |
2.3* 0.8 |
dead foetuses / litter % state ratio |
0 |
2.8 |
0.4 |
0 |
foetus weight (mean) weight (g) ±SEM |
44.8 1.5 |
46.5 1.4 |
45.7 1.2 |
41.1 2.7 |
Foetal sex ratio % male per litter ±SEM |
50 5 |
51 4 |
55 4 |
69 10 |
* P<0.05
Examination of the foetuses
Parameter |
Control data |
Low dose |
Medium dose |
High dose |
External malformations* % foetuses per litter ±SEM |
0.8 0.8 |
1.4 1.0 |
1.0 1.0 |
11.1* 8.2 |
External malformations No. of foetuses |
1 |
2 |
1 |
2 |
Skeletal malformations* % foetuses per litter ±SEM |
19.9 5.4 |
19.9 4.0 |
24.3 6.4 |
38.9 20.0 |
Skeletal malformations No. of foetuses |
30 |
39 |
44 |
4 |
Visceral malformations* % foetuses per litter ±SEM |
7.3 1.9 |
5.9 2.0 |
7.4 2.0 |
80.6* 16.3 |
Visceral malformations No. of foetuses |
13 |
11 |
12 |
11 |
% foetuses with cardiovascular % malformations ±SEM |
2.7 1.6 |
3.1 1.5 |
4.2 1.3 |
72.2* 16.5 |
* P<0.05
Applicant's summary and conclusion
- Conclusions:
- The highest dose was very toxic to dams and 90 % of implants were resorbed at the highest dose level, and 72 % of surviving foetuses had cardiac or great vessel malformations or increase in resorptions were reported in the mid and low dose 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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