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Diss Factsheets
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EC number: 455-790-3 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-07-20 to 2011-08-03
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): GASIR1
- Substance type: active substance
- Physical state: red-brown powder
- Analytical purity: 100%
- Composition of test material, percentage of components: 22% Germanium, 20% Arsenicum, 58% Selenium
- Purity test date:01/07/2011
- Lot/batch No.:3034-2
- Expiration date of the lot/batch: 30 June 2013:
- Stability under test conditions:no data
- Storage condition of test material: Room temperature (15-30°C) under nitrogen
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Laboratoire Elevage Janvier, B.P. 4105, Route des Chênes Secs, 53940 Le Genest-St-Isle CEDEX France
- Age at study initiation: Young adult rats
- Weight at study initiation: between 210 and 272g
- Housing: individual caging
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1-24 °C
- Humidity (%): 42-69%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12hrs dark/12hrs light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: none
- Details on dermal exposure:
- TEST SITE
- Area of exposure:10% of the total body surface
- % coverage: 100%
- Type of wrap if used: semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed after exposure (24h) with water of body temperature
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no, the test item was placed onto a gauze pad and moistened with water
VEHICLE
- Amount(s) applied (volume or weight with unit): one gauze pad
- Lot/batch no. (if required): 102/26 - Duration of exposure:
- 24h hours
- Doses:
- 2000mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Clinical observation: 1, 5 hours after treatment, then daily for 14 days. Body weighing: day 0, 7, 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured after a 24 hour dermal exposure to GASIR 1 followed by a 14-day observation period
- Clinical signs:
- other: No clinical signs were observed
- Other findings:
- Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen at necropsy.
Local dermal signs: Russet staining was recorded on the skin in all animals after dosing. The discoloration of the skin lasted up to day 4 in the male and day 8 in the female animals. No other local dermal signs were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item GASIR was found to be higher than 2000mg/kg body weight in male and female RjHan:(WI) Wistar rats.
- Executive summary:
An acute dermal toxicity study was performed with test item GASIR1 in RjHan:(WI) Wistar rats, in compliance with OECD Guideline No.: 402.
A limit test was carried out at 2000mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied, moistened with water, as a single dermal 24-hour exposure followed by a 14-day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Rats were euthanized and a gross macroscopic examination performed at the end of the 2-week observation period (Day 14).
The results of the study were summarized as follows:
Mortality
No mortality occurred.
Systemic clinical signs
No clinical signs were observed after the treatment with the test item or during the 14-day observation period.
Local dermal signs
No local dermal signs were observed during the entire study period. However, russet staining was observed on the skin in all animals after dosing from Day 1 to Day 4 in the males and Day 1 to Day 8 in the female animals.
Body weight
The body weight and body weight gain of GASIR1 treated animals did not show any test item-related effect.
Necropsy
There was no evidence of the test item-related observations at a dose level of 2000 mg/kg bw at necropsy. Small testes or epididymides, pelvic dilatation of the left kidney and luminal dilatation of the uterine horns were incidentally seen.
Conclusions
The acute dermal median lethal dose (LD50) of the test item GASIR1 was found to be higher than 2000 mg/kg bw in male and female RjHan:(WI) Wistar rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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