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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
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Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1992-08-17 to 1993-06-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Due to the similarity between the two enzymes, similar results are expected for beta-mannosidase.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- Dissolved oxygen dropped to < 3.0 mg O2/L at the three highest test concentrations at 48 hours. Concentrations not verified.
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was dissolved in test water to give an initial stock solution of 8790 mg enzyme concentrate dry matter/L. Serial dilutions of this stock solution were prepared with test water to give the desired series of exposure levels.
- Controls: test water - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia
- Strain: Daphnia magna Straus
- Source: Institute National de Recherche Chimique Appliqué (IRChA), France
- Age at study initiation (mean and range, SD): less than 24 hours
- Feeding during test: no - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 171 mg CaCO3/L
- Test temperature:
- 21-22 °C
- pH:
- 7.6 - 8.2
- Dissolved oxygen:
- 0.9 - 0.7 mg O2/L
- Nominal and measured concentrations:
- nominal. 281.3, 492.2, 879.0, 1582.2, 2812.8, 4922.4 mg enzyme concentrate dry matter/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass jar
- Type (delete if not applicable): loosely covered with aluminium foil
- Material, fill volume: glass, 200 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water filtered, dechlorinated and softened by passage through an Elga® water purification system. The water passes through a high pressure sand filter to remove colloids and particulate matter and a high grade activated carbon filter to move chlorine and any organic contaminants. A proportion of the supply then passes through a water softener before final reverse osmosis treatment to produce a highly purified water supply. The two grades of dechlorinated water are then remixed in the ratio of approximately 1:1 to give a supply with the desired water hardness. Batches of softened water were "aged" with aeration for at least 12 hours prior to use by recirculating through a gravel filter bed. Chlorine levels remained below detection limit at all times.
- Culture medium different from test medium: no
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light: 8 hours dark
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilization - Daphnia were considered to be immobilized if they were unable to swim for approximately 15 seconds after gentle agitation.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8 - Reference substance (positive control):
- no
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 758 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI: 1494-2022 mg enzyme concentrate dry matter/L
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 879 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: 0
- Reported statistics and error estimates:
- EC50 values and 95% confidence limits were calculated according to the method of Thompson and Weil (Thompson, W.R. & Weil, C.S., 1952, Biometrics 8; 51-54).
The NOEC (no-observed-effect concentration) is the highest concentration at and below which the incidence of immobilisation is equal or less than 10%. - Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hr EC50 value for alpha-amylase with Daphnia magna was 1758 enzyme concentrate dry matter/L (equivalent to to 212 mg active enzyme protein/L). NOEC was 879 mg enzyme concentrate dry matter/L.
- Executive summary:
A study was performed to assess the acute toxicity of alpha-amylase to Daphnia magna.
The study was conducted in accordance with OECD Guideline for Testing of Chemicals No.202, and in compliance with GLP.
Groups of 20, 1st instar Daphnia (less than 24 hours old) were exposed for 48 hours to six concentrations of the test substance dissolved in water. The incidence of immobilisation was recorded for each test and control group at 24 and 48 hours and the following values determined:
EC50 (24h): 4307 mg enzyme concentrate dry matter/L.
EC50(48h): 1758 mg enzyme concentrate dry matter/L (equivalent to 212 mg active enzyme protein/L).
NOEC (48h): 879 enzyme concentrate dry matter/L.
Reference
Description of key information
Beta-mannosidase has not been tested in aquatic invertebrates, however, a similar enzyme - alpha-amylase - has been tested in daphnia for 48 hours.
The 48 h EC50 value for alpha-amylase with Daphnia magna is 1758 mg enzyme concentrate dry matter/L corresponding to 212 mg active enzyme protein/L.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 212 mg/L
Additional information
A study was performed to assess the acute toxicity of alpha-amylase to Daphnia magna.
The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202, and in compliance with GLP.
Groups of 20, 1st instar Daphnia (less than 24 hours old) were exposed for 48 hours to six concentrations of the test substance dissolved in water. The incidence of immobilisation was recorded for each test and control group at 24 and 48 hours and the following values determined:
EC50(24h): 4307 mg enzyme concentrate dry matter/L.
EC50(48h): 1758 mg enzyme concentrate dry matter/L corresponding to 212 mg active enzyme protein/L
NOEC (48h): 879 mg enzyme concentrate dry matter/L.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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