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EC number: 231-820-9 | CAS number: 7757-82-6
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976-07-14 to 1976-10-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Sodium sulfate was used as the positive control in this study. Study was conducted in methods comparable to OECD guideline 411 "Subchronic Dermal Toxicity: 90-day study". However, only one dose level was tested. There were only 10 animals in each group. Not GLP.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Version / remarks:
- N/A
- Deviations:
- yes
- Remarks:
- see above rationale
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- no
- Remarks:
- N/A
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Sodium sulfate (positive control)
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: Positive control
- Physical state:N/A
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sweetwater Farms
- Age at study initiation: N/A
- Weight at study initiation: 2160-2820 g
- Fasting period before study: N/A
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A
ENVIRONMENTAL CONDITIONS
- Temperature (°C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): N/A
IN-LIFE DATES: From: N/A To: N/A
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: N/A
- % coverage: N/A
- Type of wrap if used: N/A
- Time intervals for shavings or clipplings: N/A
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: N/A
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg/day
- Concentration (if solution): Sodium sulfate-16 % w/w aq.; BH-Base-20 % w/w aq.
- Constant volume or concentration used: yes
- For solids, paste formed: N/A
VEHICLE
- Justification for use and choice of vehicle (if other than water): N/A
- Amount(s) applied (volume or weight with unit): 2 ml/kg/day
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
USE OF RESTRAINERS FOR PREVENTING INGESTION: no - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- N/A
- Duration of treatment / exposure:
- 65 treatments in 91 days
- Frequency of treatment:
- 65 treatments in 91 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2 ml/kg/day-16 % w/w aq.- Sodium sulfate
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: N/A
- Rationale for animal assignment (if not random): N/A
- Rationale for selecting satellite groups: N/A
- Post-exposure recovery period in satellite groups: N/A
- Section schedule rationale (if not random): N/A - Positive control:
- Sodium sulfate, the test substance of interest, was used as the positive control in the study.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: N/A
- Cage side observations included: Mortality; no further data given
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: N/A
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: N/A
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
- Time schedule for examinations: N/A
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: N/A
- Dose groups that were examined: N/A
HAEMATOLOGY: Yes
- Time schedule for collection of blood: N/A
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: all animals
- Parameters examined: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, POLY, STAB, LYMPH, MONO, EOS, BASO, NRBC
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: N/A
- Animals fasted: N/A
- How many animals: N/A
- Parameters examined: N/A
URINALYSIS: No data
- Time schedule for collection of urine: N/A
- Metabolism cages used for collection of urine: N/A
- Animals fasted: N/A
- Parameters examined: N/A
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: N/A
- Dose groups that were examined: N/A
- Battery of functions tested: N/A
OTHER: N/A - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; complete necropsy
HISTOPATHOLOGY: Yes: skin- dermatitis, acanthosis, hyperkeratosis; thyroid- vascular congestion, atrophy; adrenal- nodular hyperplasia; spleen- hemosiderosis, erythrophagocytosis, amyloidosis; bone marrow- hypocellular; spinal cord- perivascular cuffing; brain- perivascular cuffing, gliosis, granulomas, meningitis, status spongiosis; heart- myocarditis; lung- interstitial pneumonitis, perivascular lymphoid hyperplasia, peribronchial lymphoid hyperplasia, pneumonia, aspirated blood; trachea- tracheitis, aspirated blood, laryngitis; lymph node- lymphadenitis, abscess, lymphoid hyperplasia; liver- pericholangitis, nonsuppurative, hepatitis, necrosis; gall bladder- cholecystitis, mineralization; tongue- glossitis; esophagus- parasites; stomach- gastritis, parasites; pancreas- ectopic spleen; small intestin- parasites, enteritis, myositis, serositis; large intestine- parasites, enteritis, mineralization; kidney- interstitial nephritis, regenerative epithelium, mineralization, fibrosis, dilated tubules; urinary bladder- mineralization; uterus- endometritis, hyperplasia; testis- giant cells, degeneration/atrophy - Other examinations:
- Liver and kidney weights were measured.
- Statistics:
- Hematology- Males and females in the test substance group and the BH-Base group were compared to those from the respective sexes in the vehicle control group by the Student's t-test. Significant differences were determined at a 5 % risk.
Gross Pathology- Data on body weights, selected organ weights, and ratios were analyzed using analysis of variance on computer program B8944.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY- N/A
BODY WEIGHT AND WEIGHT GAIN- An overall weight gain was seen for all groups in the study.
FOOD CONSUMPTION- N/A
FOOD EFFICIENCY- N/A
WATER CONSUMPTION- N/A
OPHTHALMOSCOPIC EXAMINATION- N/A
HAEMATOLOGY-One animal in the test substance group and one animal in BH-Base group had slightly increased total white blood cell counts and an absolute neutrophilia. These increases were not considered biologically significant. One animal in the BH-Base group had moderately increased total white blood cell count with an absolute neutrophilia. This increase was indicative of a response to inflammation, but it was not likely treatment related since such an increase was observed only for this one animal. One animal in the test substance group, 3 animals in the BH-Base group, and 2 animals in the vehicle control group had RBC, HGB and HCT values below the normal range for rabbits. The decreases in these parameters were not considered treatment related since similar decreases were observed in the two control animals. Also, the group mean values for these parameters did not differ significantly (P<0.05) between treated animals and control. A statistically significant (P<0.05) increase in MCV and MCH values was noted for the females in the test substance group as compared to the vehicle control females. This increase did not appear to be biologically significant since all individual values were within a normal range for rabbits.
CLINICAL CHEMISTRY-N/A
URINALYSIS-N/A
NEUROBEHAVIOUR-N/A
ORGAN WEIGHTS- N/A
GROSS PATHOLOGY- N/A
HISTOPATHOLOGY: NON-NEOPLASTIC-The only test-related lesion observed was a subacute dermatitis. 3 animals in the vehicle control group had mild subacute dermatitis. 8 animals in the test substance group and BH-Base group had subacute dermatitis that varied from mild to moderate in nature. All other findings were normal or related to spontaneous disease. Some lesions were incidental in nature.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
HISTORICAL CONTROL DATA (if applicable)
OTHER FINDINGS- The skin from the vehicle control, BH-Base group, and the test substance group appeared normal, except that the BH-Base group was discolored from the BH-Base.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 2 other: ml/kg/day (16 % w/w)- Sodium sulfate
- Sex:
- male/female
- Basis for effect level:
- other: Histopathological examination showed that all treated animals had subacute dermatitis compared to solvent control group.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
N/A
Applicant's summary and conclusion
- Conclusions:
- Male and female New Zealand White Rabbits were treated with the test substance (2 ml/kg/day; 16 % w/w), BH-Base (2 ml/kg/day; 20 % w/w) or the vehicle control (water; 2 ml/kg/day) percutaneously 65 times in 91 days. The only test related effect, which was observed for all groups, was subacute dermatitis. LOAEL for the test substance was 2 ml/kg/day (16 % w/w).
- Executive summary:
Male and female New Zealand White Rabbits were treated with the test substance (2 ml/kg/day; 16 % w/w), BH-Base (2 ml/kg/day; 20 % w/w) or the vehicle control (water; 2 ml/kg/day) percutaneously 65 times in 91 days. Five males and five females were assigned to each group. Body weights were measured weekly. In addition, the animals were analyzed for adverse effects on skin, hematology, gross pathology, and histopathology.
The skin appeared normal in all groups. A statistically significant (P0.05) increase in MCV and MCH values was noted for the females in the test substance group as compared to the vehicle control females. This increase did not appear to be biologically significant since all individual values were within a normal range for rabbits. The only test-related lesion observed was a subacute dermatitis. 3 animals in the vehicle control group had mild subacute dermatitis. 8 animals in the test substance group had subacute dermatitis that varied from mild to moderate in nature. All other findings were normal or related to spontaneous disease. Some lesions were incidental in nature.
Based on the results of the study, the LOAEL for the test substance was 2 ml/kg/day (16 % w/w)
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