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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Sodium Perborate Monohydrate
- IUPAC Name:
- Sodium Perborate Monohydrate
- Details on test material:
- -Physical state: White granules
-Analytical purity: no data
-Lot/batch No.: no data
-Storage condition of test material: At ambient room temperature and humidity
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
-Source: Ace Animals
-Weight at study initiation: Pre-test body weight range: 272-350 g for males and 289-344 g for females
-Housing: One per cage in suspended wire mesh cages
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled
-Humidity (%): controlled
-Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- No. of animals per dose:
- 10 (5 m / 5 f) per group
- Details on study design:
- Site preparation
Treated animals:
24 hours prior to each induction, the left flank of each animal was clipped free of hair. The area was approximately 5 x 5 cm. 24 hours after each induction dose, the same area was depilated. 24 hours prior to challenge, a new area on the right flank was clipped. 24 hours after the challenge, the right flank was depilated.
Controls:
During the induction phase of the study, one group of 5 male and 5 female animals served as an untreated control. 24 hours prior to challenge, a new area on the right flank was clipped. 24 hours after the challenge, the right flank was depilated.
Experimental design:
0.5 mL/animal of the test article was applied beneath gauze patches, to the prepared sites of ten test group animals. The sites were occluded. The guinea pigs were restrained for 6 hours after which time the patches were removed. This procedure was performed once every 7 days for a total of three 6 hour insults with the test article.
Screen:
Between the induction and challenge, a screen was conducted to determine the highest non-irritating concentration of the test article. One to four animals were used. 24 hours prior to dosing, the right flank of each animal was clipped. The appropriate concentrations were applied per animal. 24 hours after exposure, the right flank was depilated. The sites were scored for redness and oedema at 1, 24 and 48 hrs after exposure.
Challenge:
14 days after the last induction exposure, both the test article and control group animals were challenged at the highest non-irritating concentration as determined by the screen. All animals were challenged at a new site on the right flank in the same manner as the induction.
Type and frequency of observations:
Induction:
Test Article Group: The treated site of each animal was examined and scored for erythema and oedema at 1 h and 24 hrs after each induction exposure period.
Challenge:
Test Article and Control Groups: The treated sites of both the test article animals and the control group animals were scored for erythema and oedema at 24 and 48 hrs after challenge exposure.
All test article and control group animals were observed once daily during the study for mortality and toxicity. Body weights were recorded pre-test and at termination in the test article and control animals. Body weights were not recorded for screen animals.
Analysis of data:
Scores greater than the greatest score seen in the control group were considered positive. Based on the percent of animals exhibiting positive scores, the test article was classified as follows:
0 – 8 %: non-sensitizer
9 – 28 %: weak sensitizer
29 – 64 %: moderate sensitizer
65 – 100 %: potent sensitizer - Challenge controls:
- Yes (see above)
- Positive control substance(s):
- not required
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % solution
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % solution. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: very slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % solution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- very slight erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: very slight erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- There was no indication for a sensitising potential of Sodium Perborate Monohydrate.
- Executive summary:
In this test according to OECD Guideline 406, five healthy male and female Hartley albino guinea pigs were treated with Sodium Perborate Monohydrate three times over three weeks in an attempt to induce a sensitizing response. Another group of 5 male and 5 female albino guinea pigs were used as controls.
Two weeks after the last induction treatment the guinea pigs were challenged at the highest non-irritating concentration. The treated sites of the test article group were examined and scored for erythema and oedema at 1 and 24 hrs after each induction exposure period. The treated sites of the test article animals and the control group animals were scored for erythema and oedema at 24 and 48 hrs after the challenge exposure. Body weights were recorded pre-test and at termination in the test article and control animals. Scores greater than the highest score observed in the control group were considered positive.
Induction:
During the induction period, erythema was absent to moderate and oedema was absent to slight.
Challenge:
After the challenge of a 5 % dilution in distilled water, erythema responses in the test group were absent to very slight. Oedema was absent. In the control group, erythema was absent to very slight and oedema was absent.
Under the conditions of this study, the test article is a non-sensitizer.
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