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EC number: 411-930-5 | CAS number: 106917-31-1 SANDUVOR 3058; SANDUVOR 3058 LIQ.
- 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
Endpoint summary
Administrative data
Description of key information
The LD50value for acute oral toxicity in rats is > 3000 mg/kg bw. The LC50 in rats was determined to be > 2.61 mg/L (4 h exposure). There are no studies on acute dermal toxicity available.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 401 (1981)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Weight at study initiation: 127 g
- Fasting period before study: 16 h
- Housing: 1-5 animals in Type II Makrolon cage
- Diet (e.g. ad libitum): R10 complete feed for rats, Ssniff Spezialfutter GmbH, Soest; ad libitum
- Water (e.g. ad libitum): Tap water; ad libitum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1°C
- Humidity (%): 60+/-5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 13.5. To: 27.5.1988 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 3000 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
signs: up to 6 h after tretement and then daily
weighing: before treatment, 1, 7 and 14 days after treatment
- Necropsy of survivors performed: yes - Statistics:
- LD50 determined according to Litchfield and Wilcoxon
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 3 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 3000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 3000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: other: Signs of toxicity related to dose levels: No signs of toxicity were noted.
- Gross pathology:
- Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of this substance was determined to be greater than 3000 mg/kg body weight.
- Executive summary:
In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the substance is greater than 3000 mg/kg of body weight. The treated animals were free of signs of toxicity. There was no influence on the increase in body weight. Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ damages.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable without restriction
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- yes
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd., England
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 and 8 weeks
- Weight at study initiation: 200 g
- Housing: in stainless steel cages with sheet material forming the sides and welded wire mesh forming the front, back and floor
- Diet (e.g. ad libitum): SDS RM1, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25°C
- Humidity (%): 35-65%
IN-LIFE DATES:
From: 24.0.4 To: 14.05.1991 - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: 80 % solution in acetone
- Mass median aerodynamic diameter (MMAD):
- 2.7 µm
- Geometric standard deviation (GSD):
- 2.03
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Aerosol generator
- Exposure chamber volume: approx. 120 L
- Method of holding animals in test chamber: Each chamber was divided by wire mesh partitions to provides 10 separate animal compartments. The test atmosphere entered through a port at the base centre of the chamber and passed out through small holes in the lower edge of the square section. Each chamber was positioned inside a large glass walled cabinet equipped with an extract fan exhausting to atmosphere through a collection filter.
- Source and rate of air: supply of clean dried air; 25 L/min
- System of generating particulates/aerosols: aerosol generator
- Method of particle size determination: Samples were taken using a Marple model 296 cascade impactor and the material collected on the stages was weighed and analysed chemically to determine the particle size distribution
- Treatment of exhaust air: 23-24°C
VEHICLE
- Composition of vehicle (if applicable): air
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter): 2.7 µm +/- 2.03
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric and chemical analysis
- Duration of exposure:
- 4 h
- Remarks on duration:
- Observation period 14 days post exposure
- Concentrations:
- Atmosphere concentration: 2.61 mg/l of air (88 % of the droplets were respirable. MMAD = 2.7 µm)
- No. of animals per sex per dose:
- One control group and 1 test group each of 5 male and 5 female rats.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: 2/day
body weight: daily
- Necropsy of survivors performed: yes
- Other examinations performed:
histopathology: lungs, liver, kidneys
- Organ weight:
lungs - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.61 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- Male: 2.61 mg/L; Number of animals: 5; Number of deaths: 0
Female: 2.61 mg/L; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: (a) During exposure: The signs were consistent with exposure to a mildly irritant aerosol and included partial closing of the eyes, wetness around the eyes and snout and abnormal respiratory movements. (b) During the observation period: Signs observed fol
- Body weight:
- Reduced bodyweight or rate of bodyweight gain was seen in some male rats for 1 day following exposure.
- Gross pathology:
- Macroscopic pathology: No treatment-related findings.
Microscopic pathology: No treatment-related findings. - Other findings:
- Food and water consumption: Food consumption was reduced in males only for 1 day following exposure to the substance. Water consumption was reduced overnight following exposure.
Lung weight to bodyweight ratio: The lung weight to bodyweight ratio for all rats exposed to the substance was considered to be within normal limits.
There were no deaths during the study. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- For the test substance, the LC50 (4-hour) was determined to be > 2.61 mg/l of air.
- Executive summary:
For the test substance, the LC50 (4-hour) was determined to be > 2.61 mg/l of air in the acute inhalation toxicity study. There were no deaths during the study. Considering pathology, no treatment-related findings were observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable without restriction
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Due to REACH Regulation, Annex VIII the performance of a third acute toxicity test beyond the already tested oral and inhalation route is not mandatory. It can reasonably be deduced that Hostavin 3058 does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of a single oral dose of 3,000 mg/kg bw in rats. Furthermore the substance does not have to be classified as eye irritating. Due its molecular structure it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 3,000 mg/kg bw/d) will be systemically available via the intact skin. Furthermore, the LC50 of an acute inhalation toxicity study was greater than 2.61 mg/L. Therefore, testing is not scientifically necessary.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- Acute toxicity after single oral application was tested in male and female rats, which received a single dose of 3000 mg/kg bw. No deaths occurred.
No clinical signs were reported. The body weights were unaffected. The necropsy did not reveal any effect. The LD50value for acute oral toxicity is > 3000 mg/kg bw.
- The test substance was tested for its inhalation toxicity properties. Single inhalation of the test item to rats at an atmosphere of 2.61 mg/L was associated with no mortality. The LC50was determined to be > 2.61 mg/L.
- No test on acute dermal toxicity is available. But due to the available data on acute oral toxicity and taking into account the substance's physico-chemical properties it can reasonably be assumed that the substance is not acutely toxic up to the limit dose for classification after dermal application.
Justification for classification or non-classification
Due to the results on acute toxicity as described above it is concluded that Hostavin 3058 has not to be classified for acute toxicity according to Regulation (EC) No 1272/2008.
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