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EC number: 285-077-0 | CAS number: 85029-52-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10/12/2006 to 19/01/2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to GLP compliance and International Guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- ACQUAPOL C1
- IUPAC Name:
- ACQUAPOL C1
- Test material form:
- other: liquid
- Details on test material:
- Test Article: Acquapol C1
Stated chemical composition: Aqueous solution of quaternary ammonium tannate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test system:
Mice (Swiss lineage) were used at ages between 7 and 10 weeks, having 22-29 grams of live weight. 5 animal/dose were used to determine the DL50 and 10 animal/dose were used for the final test, males and females. The females used were nulliparous and non-pregnant.
Test conditions:
The animals were acclimated to the laboratory conditions at least 5 days prior to the beginning of the experiment. They were mantained with ventilation of 10 to 15 air changes per room per hour, temperature between 19 and 25°C, relative air humidity between 30 and 70% and photoperiod of 12 hours in the light and 12 hours in the dark. The diet comprised commercial feed, with supplemetnation of filtered/potable water, both provided ad libitum. The animals were maintained in polycarbonate boxes with autoclaved Pinus shavings.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- deionised water
- Details on exposure:
- intraperitoneal injection at 24-h interval
- Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- Two intraperitoneal injections at volumes of 0.5 mL /animal were administered at a 24-h interval.
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
112.5
Basis:
nominal conc.
mg/kg
- Remarks:
- Doses / Concentrations:
75
Basis:
nominal conc.
mg/kg
- Remarks:
- Doses / Concentrations:
37.5
Basis:
nominal conc.
mg/kg
- No. of animals per sex per dose:
- 20 animals (5 animals/dose) were used to determine the DL50 and 10 animals/dose (5 males and 5 females) were used to the final test, males and females.
- Control animals:
- yes
- Positive control(s):
- For the positive control was used Cyclophospharride, following the same procedure.
Examinations
- Tissues and cell types examined:
- Bone marrows were exposed by removing a portion of the femur.
- Details of tissue and slide preparation:
- The animals are exposed to a test article by the adequate route and subsequentely sacrificed. These animals are sacrificed and their bone marrows are extracted and fixed on slides. The polychromatic Erythrocytes are assessed for the level of micronuclei found by microscopy.
CRITERIA FOR DOSE SELECTION:
Determination of intraperitoneal DL50:
The product ACQUAPOL C1 was applied to 20 mice (5 animal/dose) at 4 doses by intraperitoneal route. Two injections were administered at a 24-h interval. The animals remained under observation for 10 days for mortality. After this period, the intraperitoneal DL50 was estabilished by the Thompson & Weill Method. the intraperitoneal DL50 value was 150 mg/kg.
Application of the product and dose levels:
The product was applied to animals at concentrations of 37,5; 75 and 112,5 mg/kg, corresponding to 25, 50 and 75% DL50.
TREATMENT AND SAMPLING TIMES:
10 animals per dose were used, 5 females and 5 males. For the tested groups, two interperitoneal injections were administered (0,5 mL) with 24-h interval. For the negative control, deionized water was used and for the positive control Cyclophosphamide, all groups followed the same procedure. After 24 hours, all animals were sacrificed.
DETAILS OF SLIDE PREPARATION:
Once the animal were sacrificed, the femurs were removed, these were cleaned, with muscles and other tissues being removed. Later the bone marrows were exposed by removing a portion of the femur. The marrows were removed by infusion and suction of a fetal serum solution.
Later these solution were centrifuged at 1000 rpm for 5 minutes. Subsequently, they were processed and slides were prepared using an Eosin-Methylene Blue solution (Leishman Method).
METHOD OF ANALYSIS:
The slides were all coded and examined under light microscope at 1000x magnification. For each animal 1000 polychromatic and normochromatic erythrocytes were verified.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Using the readings performed, no significant differences were found between the test group and the negative control group for the number of micronuclei found. The positive control showed micronuclei in sufficient quantity, which validates the assay. Test group: .5.5% of cells showed micronucleus. Negative control group: 5.7% of cells showed micronucleus. Positive control group:10.1% of cells showed micronucleus.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The tested substance Acacia Mearnsi (ACQUAPOL C1) is not mutagenic according to the testing protocol OECD 474. - Executive summary:
A Micronucleus Assay on Mice was conducted to study potential harmful effects of the test article ACQUAPOL C1 on chromosomes and on the mitosis processes of cells. The test article was used at the doses of 25%, 50% and 75% (112,5, 75 and 37.5 mg/kg) of 0.4 to 0.5 mL/animal for 24 hours. The tested animals were maintained for 24 hours following the application and later sacrificed for the preapration of the slides. No increase in the proportion of micronuclei was observed in the etrythrocytes in the test group in comparison with the control group. The test article ACQUAPOL C1 was considered non-mutagenic when applied by intraperitoneal route to mice,
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