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EC number: 231-157-5 | CAS number: 7440-47-3
- 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:
- 6 June - 6 July 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An appropriate Buehler test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- Chromium hydroxide sulphate
- EC Number:
- 235-595-8
- EC Name:
- Chromium hydroxide sulphate
- Cas Number:
- 12336-95-7
- Molecular formula:
- CrHO5S
- IUPAC Name:
- chromium hydroxide sulphate
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- H2O4S.2Na
- IUPAC Name:
- disodium sulfate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Reaction mass of basic (III) chromium sulfate with sodium sulfate and water
- State of aggregation: green powder
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratory Animal Breeders, 88353 Kißlegg, Germany
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals: only healthy animals exhibiting no clinical signs were used for the study. The animals were not vaccinated or treated against infections either before receipt, or during the adaptation or study period.
- Age at study initiation: 5 - 6 weeks
- Weight at study initiation: 331 - 397 g
- Housing (study period): groups of two or five animals per Noryl cages; bedding material: low-dust wood shavings (Rettenmaier & Söhne, GmbH & co. 73494 Rosenberg, Germany.
- Diet (ad libitum): "PROVIMI KLIBA 3420 - Maintenance Diet for Guinea Pigs" (Supplier: PROVOMI KLIBA AG)
- Water (ad libitum): tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 40 - 70 %
- Air changes: ≥ 10/hr
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 80 % test item formulation
- Day(s)/duration:
- Days 0, 7 and 14 (exposure duration: 6 hours)
Challenge
- No.:
- #1
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 80 % test item formulation
- Day(s)/duration:
- day 28 (exposure duration: 6 hours)
- No. of animals per dose:
- Test animals: 20 animals
Control: 10 animals - Details on study design:
- RANGE FINDING TESTS:
- Induction:
In a dose range-finding test three concentrations (25, 50 and 80 %) and the vehicle were tested in each case on five guinea pigs. The suitable areas of the body were shaved 30 minutes before treatment. The patches loaded with 0.5 mL of the test item formulations or the vehicle were applied to each animal under occlusive conditions for 6 hours. At the end of the exposure period, the remaining test item was removed with sterile physiological saline solution. Twenty-one hours later the treated areas were shorn. The dermal reactions were evaluated 30 and 54 hours after the start of the application.
No signs of irritation were seen at concentrations of up to 80% (the highest tested) (6-hour occlusive application).
Based on the results of the dose range-finding study, the following concentration was selected for the inductions: 80%
- Challenge:
The challenge concentration was determined on 2 guinea pigs which were treated in the same manner as the control animals during the inductions. The concentrations (25, 50 and 80 %) used for this range-finding study were selected on the basis of the range-finding tests for the induction concentration.
The patches loaded with 0.5 mL of test item formulations or the vehicle were applied to each animal under occlusive conditions for 6 hours. At the end of the exposure period, the remaining test item was removed with sterile physiological saline solution. Twenty-one hours later the treated areas were shorn. The dermal reactions were evaluated 30 and 54 hours after the start of the application.
No signs of irritation were seen at concentrations of up to 80% (the highest tested) (6-hour occlusive application).
Based on the results of the dose range-finding study, the following concentration was selected for the challenge: 80%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Frequency of applications: once per week
- Site: Thirty minutes or 24 hours prior to test formulation appplication the skin of the left flank was shaved.
The animals in the test item group were treated with a hypoallergic patch loaded with the test item applied to the left flank. The patches were held in place on the skin using "ORABAND"® adhesive plaster. In the case of the control group animals, a hypoallergic patch loaded only with the vehicle was applied to the left flank and fixed with a strip of "ORABAND"® adhesive tape for each of the inductions. The patches were removed after an exposure period of six hours, and any remaining test item was removed with sterile physiological saline solution.
The volume applied per animal was 0.5 mL
- Concentrations:
Test animals: 80% of test item formulation
Control animals: vehicle
The treatment areas were visually assessed 30 hours after initiation of exposure.
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Site: backs and right flanks of the animals were shorn 24 hours prior to the challenge treatment. A hypoallergenic patch loaded with the 80% test item formulation was applied and fixed to the right flank of each animal in the control and test item group. As a control a patch loaded only with the vehicle was applied and fixed also to the right flank. The patches were held in place on the skin with a ORABAND self-adhesive tape for 6 hours.
The volume applied per animal was 0.5 mL.
At the end of the six-hours exposure period, the patches were removed and the remaining test item was rinsed away with sterile physiological saline solution.Twenty- one hours later the skin of the animals was shorn in the region of the treatment sites.
- Concentrations (test and control animals): 0% and 80%
- Evaluation (hr after challenge): 24 and 48 hours
C. OBSERVATIONS:
- clinical signs: at least once daily
- body weights: on day 1 before the first induction and after the last evaluation on day 31 in the control group and the test item group and at day 24 in the range-finding group. - Challenge controls:
- Five control animals were challenged with 80% test material (in physiological saline) and vehicle alone.
- Positive control substance(s):
- yes
- Remarks:
- alpha hexyl cinnamic aldehyde (vehicle: physiological saline solution; epicutanous: 40 % test item; challenge: 20 % test item)
Results and discussion
- Positive control results:
- Challenge with 20% positive control (in saline) resulted in dermal effects in 9/20 animals (45% response).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Reading:
- other: challenge
- Group:
- positive control
- Dose level:
- 20 % of the positive control
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- Skin effects (grade 1) were observed in 9/20 animals.
Any other information on results incl. tables
- dermal reactions during the induction phase were limited to one animal following the second and third exposures (Grade 1 erythema, desquamation). Similar findings were not seen in this animal following challenge.
- clinical signs: appearance and behaviour of the test item group animals were not different from the control group.
- body weight: by the end of the study the mean body weight of the treatment group animals was in the same range than that of the control group.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not a skin sensitiser.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin sensitiser. - Executive summary:
The potential of the test material (a mixture of basic chromium sulphate, sodium sulphate and water) to induce delayed contact hypersensitivity (skin sensitisation) was investigated in a three-induction Buehler study using female Hartley guinea pigs. The concentrations of the test material used for induction and challenge applications were based on the results of a preliminary study. The results of an acceptable positive control study are also reported, confirming the sensitivity of the assay. Induction was performed on 20 test animals using 6 -hour semi-occlusive application of 0.5 ml test material (80% in physiological saline); a total of three applications were made over a three-week period. Ten control animals were similarly treated using vehicle. Two weeks following the final induction application, all test and control animals were challenged using a 6- hour semi-occlusive application of the test material (80%). Dermal reactions were assessed at 24 and 48 hours following patch removal. No dermal reactions were seen in test or control animals. No evidence of sensitisation was seen under the conditions of this study.
The substance tested in this study is considered to be a worse case based on its higher water solubility, dermal penetration and pH. The negative results of this study can therefore be confidently extrapolated to chromium (III) oxide.
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