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EC number: 266-047-6 | CAS number: 65997-18-4 Frit is a mixture of inorganic chemical substances produced by rapidly quenching a molten, complex combination of materials, confining the chemical substances thus manufactured as nonmigratory components of glassy solid flakes or granules. This category includes all of the chemical substances specified below when they are intentionally manufactured in the production of frit. The primary members of this category are oxides of some or all of the elements listed below. Fluorides of these elements may also be included in combination with these primary substances.@Aluminum@Manganese@Antimony@Molybdenum@Arsenic@Neodymium@Barium@Nickel@Bismuth@Niobium@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Cerium@Silver@Chromium@Sodium@Cobalt@Strontium@Copper@Tin@Gold@Titanium@Iron@Tungsten@Lanthanum@Vanadium@Lead@Zinc@Lithium@Zirconium@Magnesium
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- November 1957 - July 1958
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well documented study report (no GLP) which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 960
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Groups of albino rats and dogs were exposed to aerosols of boron oxide in dynamic chambers. The rats were individually caged in racks, 10 cages each, which were randomly changed for each exposure. The animals were exposed for 6 hours a day for 5 days a week.
70 rats exposed for 24 weeks 77 mg/m³,
4 rats exposued for 12 weeks, 175 mg/m³
20 rats exposed for 10 weeks, 470 mg/m³
3 dogs exposed for 23 weeks , 57 mg/m3. - GLP compliance:
- no
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- other: rats and dogs (only females)
- Strain:
- other: rats (albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No further data available
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: Rats:
Dose group of 77 mg/m³: 2.5 microns;
Dose group of 175 mg/m³: 1.9 microns;
Dose group of 470 mg/m³: 2.4 microns;
Dogs:
Dose group of 57 mg/m³: 2.4 microns. - Details on inhalation exposure:
- Groups of albino rats and dogs were exposed to aerosols of boron oxide in four dynamic chambers having volumes of 20, 100, 1000, and 1000 liters, respectively. The rats were individually caged in racks, 10 cages each, which were randomly changed for each exposure. The animals were
exposed for 6 hours a day for 5 days a week.
Boron oxide, which was presized, was dispersed from modified Wright dust dispersers into the chambers at a fairly constant rate throughout the exposure period. Large particles were eliminated by means of a settling column between the disperser and the mixing bowl, where air entered the top of the chamber. A flow of room air of about half of the chamber volume per minute was maintained. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples for determination of airborne concentrations of boron oxide were withdrawn from the chambers every hour and collected by means
of a filter paper sampler containing 5/ 8-inch disc s of Knowlton filter paper, Grade 100. The boron oxide was dissolved in water and the amount estimated by the carmine sulfuric-acid method. Standard solutions of boron oxide were run with every set to reduce possible errors in time of color development, acid concentration, or temperature. Samples for particle-size determinations of the aerosol were collected by means of a modified Cascade impactor, and mass median diameters (MMD) were derived by use of predetermined stage calibrations for boron oxide. - Duration of treatment / exposure:
- Rats:
Dose group of 77 mg/m³: 24 weeks;
Dose group of 175 mg/m³: 12 weeks;
Dose group of 470 mg/m³: 10 weeks;
Dogs:
Dose group of 57 mg/m³: 23 weeks - Frequency of treatment:
- 6 hours a day for 5 days a week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
77, 175 and 470 mg/m³ (rats)
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
57 mg/m³
Basis:
nominal conc.
- No. of animals per sex per dose:
- Rats:
Dose group of 77 mg/m³: 70 animals;
Dose group of 175 mg/m³: 4 animals;
Dose group of 470 mg/m³: 20 animals;
Dogs:
Dose group of 57 mg/m³: 3 animals. - Control animals:
- yes
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
HAEMATOLOGY: Yes (see table 6 in "Results)
CLINICAL CHEMISTRY: Yes (see table 2 and 3 in "Results")
URINALYSIS: Yes
- Metabolism cages used for collection of urine: Yes
The urine of control and exposed rats was analyzed for boron by spectrographic methods.
OTHER:
- The fragilition of rat femurs, as measured by the breaking point, is shown in table 5. The ratio of the fracture weight in kg to the least diameter in mm was taken as the index for comparison of bone fragilition.
- Roentgenograms of control rats and those exposed to 77 mg/m³ were made. - Sacrifice and pathology:
- - Tissues of the lungs, trachea, pancreas, thyroids, adrenals, eyes, femurs, ribs, bone marrow, liver, heart, spleen, kidneys, brain, stomach, intestines, ovaries, testes, lymph nodes, and muscles have been examined histologically for evidence of pathology.
Samples of the above tissues of exposed and control animals were dissolved in 20% sodium hydroxide and analyzed spectrographically for boron content.
- The percentage of body weight of heart, lungs, liver, and kidneys from five rats exposed to the aerosol for 20 weeks was compared with control rats. - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- a slight reddish exudate from the nose (470 mg/m³)
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- a slight reddish exudate from the nose (470 mg/m³)
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- considerable differences in the pH, volume, and creatinine coefficient.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- onsiderable amounts of boron were excreted by the exposed rats and averaged 11.90 mg/kg/day
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
At no time were any toxic signs noticed, nor were there any deaths from inhalation of the boron-oxide aerosol. However, some of the rats exposed to a concentration of 470 mg/m³ had a slight reddish exudate from the nose. Since these animals were covered with the dust there was probably local irritation of the external nares and some irritation from scratching. This concentration produced a dense cloud of fine particles. Workers experienced in the aerosol field expressed their belief that visibility in such a cloud would probably be limited to 10 to 12 feet.
BODY WEIGHT AND WEIGHT GAIN
The weight changes of control and exposed aniamls are shown in figure 2 (please see attached). Since female rats bad almost reached full growth at the time of initiation of therre exposures, whereas males far from their peak growth were used, the different growth rates of the two sexes are not believed to be attributable to the exposure.The control rats grew about 9% faster than those exposed to a concentration of 470 mg/m³, whereas those exposed to 77 mg/m³ gained the same amount or slightly more than their controls for the same period of time. The mature dogs showed slight fluctuations in weight but no general trend in either direction.
HAEMATOLOGY
There was a slight and probably insignificant rise in the leucocyte counts of the exposed dogs that may suggest a slight response to poisoning
by the aerosol. There were no other changes, except for the usual fluctuations, and no significant difference from the control (table 6).
CLINICAL CHEMISTRY
There were no modifications in the sugar or albumin content of the urine of the exposed rate and the controls. There were considerable
differences, however, in the pH, volume, and creatinine coefficient, as shown in table 2. The changes were analyzed by the T-test and found to be significantly different, with the following values of probability: volume P = 5%, pH and creatinine coefficient P = 1%. The formation of boric acid by hydration in the body probably caused the greater acidity of the urine of the exposed rats. The increased volume is undoubtedly accounted for by the known diuretic property of boric acid. The cause of increased creatinine excretion is not known. These values returned to normal a week after termination of the exposure.
Chemical analyses of six common blood constituents are given in table 3, for groups of rats exposed for 24 weeks to two concentrations of aerosols. There were no constant changes in either direction and no significant difference from the control values. Since no control values were determined
for the female rats the possible significance of apparent changes in sugar and lactic acid were undetermined.
In table 7 are given the results of the chemical analyses of some constituents of the dog blood. As with the rat blood, there were no changes from the pre-exposure values nor from those of the control dog. Sulfobromophthalein retention tests, for liver damage, were also negative as compared to the control.
URINALYSIS
The urine of control and exposed rats was analyzed for boron by spectrographic methods. The data show that considerable amounts of boron were excreted by the exposed rats and averaged 11.90 mg/kg/day. The controls excreted 0.24 mg/kg/day, or about 10 µg/mL. The data are presented
in table 4.
ORGAN WEIGHTS
The percentage of body weight of heart, lungs, liver, and kidneys from five rats exposed to the aerosol for 20 weeks was compared with control
rats. The differences were not significant.
HISTOPATHOLOGY: NON-NEOPLASTIC
No differences were noted between the tissues of the exposed and control animals. There were no signs of pneumoconiosis. Samples of the tissues of exposed and control animals were dissolved in 20% sodium hydroxide and analyzed spectrographically for boron
content. Standard solutions of boron oxide in water were aaalyzed and showed that by the method a minimum of 2.5 µg/mL of boron could be detected. The use of the method would have detected 0.011% of boron in the lung sample analyzed and a thid that amount in the other tissues. The rats had been exposed for 6 weeks to a concentration of 77 mg/m³ of boron oxide. There was no boron found in any of the samples. The rats were, however, in metabolism cages for 60 hours after exposure and before being killed. If boron had been present, it is possible that it was eliminated during that time.
OTHER FINDINGS
The fragilition of rat femurs, as measured by the breaking point, is shown in table 5. The ratio of the fracture weight in kg to the least diameter in mm was taken as the index for comparison of bone fragilition. There was no significant difference between the controls and those exposed to the aerosol, as shown by the t- test.
Roentgenograms of control rats and those exposed to 77 mg/m³ of boron oxide for 10 weeks showed no detectable effects.
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- systemic (rats)
- Effect level:
- 470 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No systemic effects were noted at this dose level
- Dose descriptor:
- NOAEC
- Remarks:
- local (rats)
- Effect level:
- 175 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: due to local effects (slight reddish exudate from the nose) observed in animals at 470 mg/m³
- Dose descriptor:
- NOAEC
- Remarks:
- systemic (dogs)
- Effect level:
- 57 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No changes or toxic signs were noted.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Exposure animals to aerosols of boron oxide
Species |
No. |
Chamber size |
Average concentration |
Duration of exposure |
Particle size, MMD |
liters |
mg/m³ |
weeks |
microns |
||
Rat |
70 |
1000 |
77 |
24 |
2. 5 |
Rat |
4 |
20 |
175 |
12 |
1.9 |
Rat |
20 |
100 |
470 |
10 |
2.4 |
Dog |
3 |
1000 |
57 |
23 |
2. 4 |
Table 2. The pH, volume and creatinine coefficient for urine of control and of exposed rats (concentration 77 mg/m³)
Weeks of exposure |
pH |
Volume |
Creatinine coefficient |
|||
Exposed |
Control |
Exposed |
Control |
Exposed |
Control |
|
ml/kg/day |
mg/kg/day |
|||||
4 |
8.66 |
8.94 |
30 |
12 |
14.7 |
2.2 |
6 |
- |
33 |
43 |
9.3 |
4.0 |
|
8 |
8.30 |
8.85 |
44 |
20 |
13. 9 |
1.6 |
10 |
- |
- |
52 |
24 |
18. 1 |
3. 6 |
12 |
- |
- |
41 |
21 |
17. 2 |
3.8 |
14 |
- |
- |
55 |
22 |
12. 1 |
10.8 |
16 |
8.24 |
8.94 |
28 |
13 |
18. 1 |
7.6 |
18 |
8.16 |
8.78 |
23 |
11 |
16.3 |
11.8 |
20 |
7.38 |
9.05 |
17 |
11 |
17. 9 |
11.2 |
22 |
8.24 |
8.90 |
24 |
17 |
14. 9 |
7.2 |
Average |
8.16 |
8.91 |
34.7 |
19.4 |
15.3 |
6.4 |
Table 3. Chemical analyses of the blood of rats exposed to aerosols of boron oxide
Time of exposure |
Sugar |
Lactic acid |
Protein |
Inorganic phosphorus |
Creatinine |
Cholesterol |
weeks |
mg |
% |
g % |
m % |
||
Females exposed to 470 mg/m³ |
||||||
2 |
119 |
29 |
5.9 |
10. 5 |
1.0 |
- |
4 |
53 |
50 |
5. 5 |
8.4 |
1.2 |
- |
6 |
52 |
52 |
7. 5 |
- |
- |
- |
8 |
* 78 |
30 |
6. 6 |
4. 7 |
- |
- |
10 |
55 |
60 |
7.4 |
5.1 |
- |
- |
Males exposed to 77 mg/m³ |
||||||
2 |
116 |
37 |
7.2 |
5.6 |
- |
- |
4 |
120 |
14 |
9.6 |
4.4 |
- |
- |
6 |
87 |
47 |
5.8 |
4.2 |
0.8 |
- |
8 |
80 |
39 |
6.5 |
5.0 |
1.2 |
- |
10 |
120 |
32 |
6.2 |
4.4 |
0.9 |
- |
12 |
59 |
28 |
4.5 |
5.4 |
0.8 |
- |
14 |
88 |
29 |
7. 3 |
5.1 |
0.9 |
- |
16 |
104 |
30 |
6. 7 |
5.2 |
1.0 |
83 |
18 |
86 |
27 |
6.8 |
4.4 |
0. 6 |
- |
20 |
161 |
13 |
7.4 |
4.6 |
1.0 |
91 |
22 |
138 |
37 |
6.8 |
5. 1 |
0.8 |
121 |
24 |
82 |
55 |
7.5 |
4. 7 |
0.5 |
127 |
Average |
103 |
32 |
6.8 |
4.8 |
0.94 |
101 |
Male controls (13 samples) |
||||||
Average |
104 |
37 |
6.8 |
5.5 |
1.04 |
100 |
Table 4. Boron content of urine control rats and of rats exposed to aerosols of boron oxide
Weeks of exposure |
Urinary boron content* (mg/kg/day) |
|
|
Controls |
Exposed |
2 |
- |
16.6 |
4 |
0.7 |
12.3 |
6 |
0.2 |
7.4 |
8 |
0.3 |
1.9 |
10 |
0.2 |
5.5 |
12 |
0.1 |
23.2 |
14 |
0.2 |
2.8 |
16 |
0.1 |
20.7 |
18 |
0.1 |
20.7 |
20 |
0.3 |
7.0 |
22 |
0.2 |
12.7 |
Average |
0.24 |
11.9 |
* When the urine of the rats was analyzed a week after the end of the period of exposure, the boron content in the urine of the control rats and exposed rats was 0.3 mg/kg/day. After a 2-week interval, the boron content in the urine of the control rats wae 0.5 mgjkglday; in the urine of the exposed rats, it was 0.9 mg/kg/day.
Table 5. Fragility of femurs of control rats and rats exposed to an aerosol of boron dioxide
Group |
No. |
Least diameter |
Fracture weight |
Fracture weight least diameter |
Standard deviation |
mm |
kg |
av* |
|||
Controls |
14 |
2.68 |
6.6 |
2.43 |
0.69 |
Exposed* |
8 |
2.70 |
6.2 |
2.30 |
0.87 |
* Arerages of groups that had been exposed for 6 and 10 weeks to a concentraam of 470 mg/m³
Applicant's summary and conclusion
- Conclusions:
- No toxic signs were evident in any of the animals. NOAEC of 470 mg/m³ for systemic toxicity in rats is established based on the study results. NOAEC of 175 mg/m³ is appropriate for local effects due to irritation of noses of rats. NOAEC of 57 mg/m³ for dogs is based on the absence of any toxic effect.
- Executive summary:
Groups of albino rats and dogs were exposed to aerosols of boron oxide in dynamic chambers. The rats were individually caged in racks, 10 cages each, which were randomly changed for each exposure. The animals were exposed for 6 hours a day for 5 days a week. 70 rats were exposed for 24 weeks (77 mg/m³), 4 rats were exposued for 12 weeks (175 mg/m³), 20 rats were exposed for 10 weeks (470 mg/m³) and 3 dogs were exposed for 23 weeks to 57 mg/m³. The test concentrations were verified analytically and mass median diameters (MMAD) were derived.
No toxic signs were evident in any of the animals. All groups of rats exposed to concentrations of 77 and 470 mg/m³ gained weight at about the same rate as their controls.Chemical analyses of dog and rat blood, and urine showed no changes from control values, except for an increased urinary excretion of creatinine in the rats, and lower pH, increased volume, and increased boron content in the rat urine. No changes were found as a result of aerosol exposures in the following:
1. rattissues and organs
2. bone fragility
3. roentgenograms of rat bones
4. hematology of dog blood
5. sulfobromophthalein retention
6. rat organ weight.
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.
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