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EC number: 234-390-0 | CAS number: 11138-47-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-01-17 to 1989-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- 10486-00-7
- EC Number:
- 600-611-8
- Cas Number:
- 10486-00-7
- IUPAC Name:
- 10486-00-7
- Reference substance name:
- Sodium perborate tetrahydrate
- IUPAC Name:
- Sodium perborate tetrahydrate
- Details on test material:
- -Physical state: Colourless crystals
-Purity: > 98 %
-Lot/batch No.: 10/10/88
-Stability under test conditions: Stable throughout the test according to Sponsor's information
-Storage condition of test material: Kept in closed container in a refrigerator
-Other: Solubility: 23 g/L (20°C); pH-value: 10.1 - 10.4 (2% solution, 20°C)
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Bor:WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Winkelmann, Borchen
-Age at study initiation: 7 weeks
-Weight at study initiation: males 139 - 173 g; females: 108 - 131 g
-Fasting period before study: no
-Housing: single in Macrolon cages type II
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 20 - 22
-Humidity (%): 40 - 55
-Air changes (per hr): no data
-Photoperiod: 12 hrs dark /12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 % aqueous tylose suspension
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS
Sodium Perborate Tetrahydrate was administered in a dose of 1000 mg/kg bw. The substance was suspended in a 1 % aqueous tylose suspension. The administration volume was 4.64 mg/mL kg bw, i.e. the content of the test item in suspension was 215 mg/mL. To prevent from sedimentation, the suspension was stirred during administration.
VEHICLE
-Justification for use and choice of vehicle: Tylose was used to achieve a uniform suspension - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Content and stability of the test item in the aqueous tylose suspension were examined by the Sponsor prior to the first administration. These results were found to be within acceptable limits.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily (7 days per week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg b.w.
Basis:
other: actual (nominal) dose per kg bw
- No. of animals per sex per dose:
- 5 m / 5 f
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale:
The test item was administered orally during a dose-range finding study (23 days) at a dose of 1000 mg/kg bw/day. Only salivation was observed as clinical sign and two animals showed slight reddening of the glandular stomach. According to these findings a dose of 1000 mg/kg bw/day was selected for the definite study.
Post-exposure period: no
Rationale for selecting satellite groups: No recovery group selected - Positive control:
- Not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
1 - 2 times daily incl. observations for mortality
DETAILED CLINICAL OBSERVATIONS: Yes
Daily check for clinical signs (behavioural changes, first occurrence, progress, intensity and duration of signs of toxicity)
Prior to study start and at termination: testing of reflexes (pain, pinna and corneal reflexes) as well as examinations of eyes, teeth, or hearing.
BODY WEIGHT: Yes
once weekly, starting with pre-study period
FOOD CONSUMPTION: Yes
once weekly
FOOD EFFICIENCY: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
prior to study start and at termination in all animals
HAEMATOLOGY: Yes
during week 4 in all animals
Anaesthetic used for blood collection: Yes (CO2 anaesthesia)
Animals fasted: no data
Parameters examined: RBC, Hct, Hb, WBC, MCH, MCHC, MCV, thrombocytes (platelets) and differential leucocyte count
CLINICAL CHEMISTRY: Yes
during week 4 in all animals
Animals fasted: no data
Parameters examined: Alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, BUN, Ca, Cl, CHE, CK, creatinine, gamma-glutamyltransferase, glucose, inorganic phosphorus, K, Na, total bilirubin, total cholesterol, total protein, triglycerides
URINALYSIS: Yes
during week 4 in all animals
Metabolism cages used for collection of urine: Yes
Animals fasted: no data
Parameters examined: bilirubin, glucose, haemoglobin, ketones, leucocytes, nitrite, osmolality, pH-value, protein, urobilinogen and microscopic sediment examination in animals whose urine state showed pathological changes in leucocytes, protein, or haemoglobin. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
all animals
HISTOPATHOLOGY: Yes
all animals
adrenal glands, bone (sternum), bone marrow smears, brain, caecum, colon, duodenum, heart, ileum, jejunum, kidneys, liver, lungs, ovaries, rectum, skin, spleen, stomach, testes - Statistics:
- DUNNETT or STEEL-Test
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Salivation in almost all rats. Stilted gait, sunken sides and piloerection in one male. In 2 animals, piloerection during the last 4 days. No mortality.
BODY WEIGHT AND WEIGHT GAIN
Weight gain reduction in males at about 15 %
FOOD CONSUMPTION
Reduced in males up to 15 %
HAEMATOLOGY
Slight decrease of red blood cell parameters and increase of platelets in rats of both sexes. Decrease in white blood cell count in males due to reduction of absolute lymphocyte numbers.
CLINICAL CHEMISTRY
Possibly treatment-related changes present as reduction of total cholinesterase and protein (both sexes), albumin (males), cholesterol and calcium (females).
ORGAN WEIGHTS
Absolute organ weights of brain, heart, kidneys and testes were slightly reduced in males. Relative weights of adrenals were increased in males, relative liver weight was slightly increased in females.
GROSS PATHOLOGY
Reduced spleen size in treated males.
HISTOPATHOLOGY
NON-NEOPLASTIC: Mild test item-related reduction of the splenic parenchyma in males. Slight acanthosis and hyperkeratosis in the forestomach and hyperplasia of the fundic mucosa in males and females.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- < 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Dose level (mg/kg bw/day) |
0 |
1000 |
Clinical signs (entire study) |
||
Males / Females |
|
salivation, piloerection |
Body weights (g; group means at week 4) |
||
Males |
258.4 |
216.1* |
Females |
166.1 |
167.0 |
Food consumption (g/animal/d; group means during 4 weeks) |
||
Males |
19.7 - 20.8 |
16.2 - 18.1*/** |
Females |
14.4 - 14.8 |
13.8 - 14.7 |
Haematology (group means at week 4) |
||
Males |
|
|
Erythrocytes (pro pl) |
6.94 |
6.05* |
Haemoglobin (g/dL) |
15.9 |
14.3* |
Haematocrit (L/L) |
0.449 |
0.384* |
MCHC (g/dL) |
35.4 |
37.3* |
Platelets (pro nL) |
1015 |
1175* |
WBC (pro nL) |
12.9 |
9.4* |
Lymphocytes (pro nL) |
11.36 |
8.19+ |
Females |
|
|
Erythrocytes (pro pl) |
6.60 |
5.71* |
Haemoglobin (g/dL) |
15.7 |
13.6* |
Haematocrit |
0.415 |
0.362* |
Platelets (pro nL) |
1020 |
1200* |
Clinical chemistry (group means at week 4) |
||
Males |
|
|
Total bilirubin (umol/L) |
2.68 |
3.42* |
Total protein (g/L) |
59.63 |
52.35* |
AKP (IU/L) |
445.52 |
311.30* |
Creatinine (umol/L) |
41.04 |
33.67* |
Phosphorus (mmol/L) |
3.09 |
3.42* |
Cholinesterase (IU/L) |
105.80 |
87.17* |
Sodium (mmol/L) |
144.0 |
142.6* |
Albumin (g/L) |
29.70 |
27.22* |
Potassium (mmol/L) |
6.63 |
7.51* |
Females |
|
|
Total protein (g/L) |
63.08 |
56.44* |
Cholesterol (mmol/L) |
1.94 |
1.29* |
Cholinesterase (IU/L) |
382.04 |
310.50* |
Calcium (mmol/L) |
2.89 |
2.80* |
AKP (IU/L) |
338.79 |
227.12* |
Organ weights (g; group means) |
||
Males |
|
|
Body weight at necropsy |
249 |
206* |
Brain (absolute) |
1.73 |
1.58* |
Heart (absolute) |
1.11 |
0.92* |
Kidney (left; absolute) |
0.97 |
0.80* |
Testis (left; absolute) |
2.09 |
1.71* |
Testis (right; absolute) |
2.11 |
1.74** |
Adrenal (left; relative) |
0.009 |
0.012* |
Adrenal (right; relative) |
0.008 |
0.011** |
Females |
|
|
Body weight at necropsy |
157 |
159 |
Liver (relative) |
4.44 |
4.87* |
Macroscopic findings |
||
Males |
|
|
Spleen (reduced size) |
0/5 |
2/5 |
Histopathology |
||
Males |
|
|
Spleen: reduction of parenchyma |
0/5 |
5/5 |
Stomach Akanthosis/Hyperkeratosis Hyperplasia of fundic mucosa
|
0/5 0/5 |
4/5 5/5 |
Females |
|
|
Stomach Akanthosis/Hyperkeratosis Hyperplasia of fundic mucosa Subacute gastritis |
1/5 0/5 0/5 |
4/5 4/5 1/5 |
*5 % level (Dunnett-Test);**1 % level (Dunnett-Test);+5 % level (Steel-Test)
All H&E stained slides of the testes were re-examined. In addition to the routine light microscopic examination each of the 14 stages of the seminiferous epithelium was checked by careful examination of a representative number of seminiferous tubule cross sections in the respective cycle stage with the high power dry objective. Special attention was paid to possible toxic effects, e.g. degeneration of germ cells or sperm retention.
Groups |
Control (5 males) |
1000 mg/kg bw (5 males) |
Focal tubular atrophy |
2/5 |
3/5 |
Inhibition of spermiation |
2/5 |
5/5 |
The re-examination confirmed the initial examination, in which no significant toxicological findings were present at 1000 mg/kg bw in the testis.
A minimal inhibition of spermiation (stage IX and X tubules) was present occasionally in some tubules of treated animals but also in control rats. This finding was not considered as indicative for testicular toxicity, as it is a well-known spontaneous background findings in rats.
A minimal to slight focal tubular atrophy was present in control and treated rats. This finding is a frequent spontaneous finding in the rat strain used and thus not considered treatment-related.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of Sodium Perborate Tetrahydrate in rats after 4 weeks of oral (gavage) administration at a daily dose of 1000 mg/kg bw was slightly below 1000 mg/kg bw/d.
- Executive summary:
A 4-week oral toxicity study with Sodium Perborate Tetrahydrate was performed as Limit test (one dose level of 1000 mg/kg bw/d) according to OECD Guideline 407.
The test item induced changes in body weight and food consumption, laboratory parameters and induced histopathological changes in the spleen (reduced parenchyma) and had irritating effects to the mucous membrane of the stomach.
Most of the functional changes were slight, within normal ranges and could be attributed to the histopathological changes. The target organs were identified as spleen and stomach.
A re-examination of the testes was requested by the Sponsor due to the well-known testicular toxicity of sodium borate and boric acid. The histopathological examination confirmed the original findings, i.e. there was no testicular toxicity in males.
It was concluded that the NOAEL for males or females was slightly below 1000 mg/kg bw/d.
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