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EC number: 413-750-2 | CAS number: 171090-93-0 ANOX 1315; ANOX BF; DURAD AX 38
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 29 1991 to February 12 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.1
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Not specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Cr1:CD (SD) BR rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight (on receipt): Males: 225-250 g
Females: 200-225 g
Age (on receipt): About 7-9 weeks
Supplier: Charles River Italia S.p.A. Via Indipendenza, 11, 22050 - CALCO (Como),
Shipping slip number: 00621 dated Jan. 21, 1991
Acclimation: at least 5 days before the start of the test. Animals were observed daily to ascertain their fitness for the study.
Housing: 5 animals/sex/cage in air-conditioned rooms.
- Temperature: 22 ° C ± 2
- Relative humidity: 55% ± 10
- Air changes: about 20/hour filtered on HEPA 99.97%.
- Light: 12 hour cycle (7 a.m. - 7 p.m.)
- Cage size: grill cages cm 40.5x38.5x18h with stainless steel feeder. The waste that
dropped through the grill bottom on removable paper as periodically disposed of.
Animal identification: By nicks or tipping's of the outer ear. Cage card gave experiment number,
dosage group, sex and date of administration.
Diet: GLP 4RF21 pelleted diet produced by Charles River Italia' s feed licensee Yucedola
Sl., Settimo Yilanese. The declared contents, on the label, on dry m a t t e r basis (moisture 12%), were:
crude protein 13.50%
crude fat 3.00%
crude fiber 6.00%
ash 7.00%
The diet was supplemented by the Producer with vitamins and trace elements. The Producer supplies a certificate of anal:-sis for nutrients and contaminants, the levels of which are within the limits proposed by EPA-TSC-4 (44FR:4053-44093, July 26, 1979). RBM has the animal feed re-analyzed at Least twice a year for bacterial contamination. The diet was available "ad libitum" to the animals.
Water: from the municipal water main system. water is filtered and distributed "act· libitum" to the animals by an automatic valve system.
Periodically drinking water is analyzed for microbiologic count. heavy metals, other contaminants (e.g. solvents, pesticides) and other chemical and physical characteristics. The acceptable limits of quality of the drinking water were those defined in EEC Directive 80/778.
Contaminants that might interfere with the objectives of the study ere not expected to be present in diet or drinking water.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- Preparation and administration of test article
Just before the treatment of the animals a weighed amount of test article , was suspended with the suitable volume of 0.5% methylcellulose 400 cps water solution. In order to maintain a good homogeneity the suspension was kept stirred by magnetic
stirring until the end of the treatment.
The suspension was administered at the constant volume of 20 ml/kg. The volumes to be administered were measured with appropriately gauged plastic syringes.
The administration was done by gavage to rats which had been fasted about 16 hours.
Analysis:
Stability - Not requested by the Sponsor
Concentration check - Not requested by the Sponsor - Doses:
- Single dose of 5000 mg/Kg body weight.
- No. of animals per sex per dose:
- 5 males + 5 females/group
- Control animals:
- not specified
- Details on study design:
- Administration route: oral (by gavage)
Reason for selection of administration route : Possible accidental ingestion by humans.
Administration frequency: Single.
Experimental design: The test article was administered as follows:
Dose: (mg/Kg): 5000
Administration volume (ml/Kg): 20
Treatment date: January 29 1991
Observation period: 14 days after the administration.
Observation of clinical signs and mortality: At 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
Body weight: Once pre-trial, on days 1, 3, 8 and 14. On day 1 the animals were weighed after a 16 hour fasting period. The volume of administration was based on day 1 body weight. Feed was returned to rats three hours after the test article administration.
Gross pathology: On all the animals that died during the study and all the animals (fasted overnight) killed by excision of the femoral arteries, after i.p. anaesthesia with 5% sodium pentobarbital, at the end of the observation period.
Histology: Portions of abnormal entities found in any of the necropsied animals were collected. The tissue samples were fixed and preserved in 10 % buffered formalin.
Histological examinations were not performed as no macroscopic findings emerged from necropsy. - Statistics:
- The LD50 calculations were not possible.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in animals treated at 5000 mg/Kg.
- Clinical signs:
- other: Signs of toxicity related to dose levels: Piloerection was observed only two hours after test article administration in two male and three female rats.
- Gross pathology:
- Effects on organs:
At the gross pathology examination carried out at the end of the observation period no changes were noted in all necropsied animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No signs of toxicity were seen in any animals dosed with 5000 mg/Kg of the test article. Therefore the LD50 of the test article is concluded to be >5000 mg/Kg bw.
- Executive summary:
A acute oral toxicity study was carried out in rats treated with test article ANOX – BF, according to test guideline 84/449/EWG, B.1, in compliance with GLP.
The test article was suspended in 0,5% methylcellulose 400 cps water
Solution and administered to rats at the volume of 20 ml/kg.
All rats were treated after a 16 hrs fasting period. The animals were weighed on days 1, 3, 8 and 14; clinically observed for 14 days following the treatment and killed at the end of the study by excision of the femoral arteries after having been completely anesthetized with an i.p. injection of 5% sodium pentobarbital . A thorough autoptic examination was performed in animals killed at the end of the observation period .
No animals died during the observation period.
Two male and three female treated rats only showed transient piloerection 2 hours after treatment.
The body weight gain appeared unaffected by treatment .
At the gross pathology examination performed on rats killed at the end of the observation period no changes were noted.
In conclusion ANOX - BF, when administered by oral rout to rat, under' the conditions adopted in this study, did not cause overt signs of toxicity- and showed an LD50 higher than 5000 mg/kg.
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