Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 253-446-5 | CAS number: 37288-54-3
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 August 2000 - 7 February 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions for the study were prepared by adding the test substance to a volumetric flask containing about 300 mL of water from the test tank. The flask contents were shaken to ensure a homogeneous solution. The content was then decanted into the test tank and stirred to ensure adequate mixing. The l tank had 20 L of test solution and test water for the test solutions and control, respectively. 10 rainbow trout were added to each tank within 30 min of preparation. Fish were transferred to freshly prepared solutions at 24 h intervals.
- Controls: Test water - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss
- Source: Selcoth Fish Farm, Moffat
- Length at study end (length definition, mean, range and SD): 4-6 cm
- Feeding during test: no
ACCLIMATION
- Acclimation period: at least 12 days
- Acclimation conditions (same as test or not): During holding fish were fed on a suitable standard fish diet. The fish were not fed for the period 24h before the commencement of the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 64-68 mg/L as CaCO3
- Test temperature:
- 14.5-14.8°C
- pH:
- 6.46-7.28
- Dissolved oxygen:
- 78.8-90.4 % air saturation value
- Salinity:
- -
- Nominal and measured concentrations:
- nominal: 100 mg TOS/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass aquarium
- Material, size, fill volume: moulded glass, 25L capacity, 20L volume
- Aeration: yes
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted fresh water prepared at Inveresk. The water was prepared by addition of salts to high quality water (reverse osmosis grade)
- Conductivity: 174 -199.8 µS
- Culture medium different from test medium: no
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): The fish were observed at 0, 1, 3, 6 and 24h and hereafter daily up to 96h.
At the termination of the limit test, the length (from the tip of the snout to the caudal puncture) and weight of each surviving fish was recorded.
TEST CONCENTRATIONS
- Limit test: 105.8 mg enzyme concentrate dry matter/L - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 105.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 105.8 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: enzyme concentrate dry matter
- Basis for effect:
- mortality (fish)
- Details on results:
- - Behavioural abnormalities: No
- Mortality of control: One fish died as a result of aggressive behaviour of a dominant fish.
- Other adverse effects control: No unusual behaviour was exhibited by all other fish during the test and all appeared healthy and active througout. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Under the conditions of the test, Mannanase, batch PPE6432 was not found to be acutely toxic to rainbow trout (Oncorhynchus mykiss). Consequently, the 96-hour LC50 value for mannanase could not be calculated and must be > 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L). The "no-observed effect concentration" was the highest concentration 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L).
- Executive summary:
The acute toxicity of Mannanase, batch PPE6432 to rainbow trout (Oncorhynchus mykiss) was assessed by conducting a limit test at nominal concentration of 105.8 mg enzyme concentrate dry matter/L. The study was conducted over a 96-h period under semi-static conditions with the solutions renewed at 24h intervals througout the the test period. The study was performed according to OECD 203 (1992) and in compliance with GLP.
One test tank at 105.8 mg enzyme concentrate dry matter/L and one control tank were included in the test. Ten rainbow trout were added to each tank. Water quality parameters (pH, temperature, conductivity and dissolved oxygen concentration) were measured at the beginning and at 24h intervals in all tanks. All test solution prameters remained within acceptable limits.
No mortalities or other adverse effects were recorded in the test tank througout the study period. In the control tank one fish died as a result of aggressive behaviour by a dominant fish. The results indicate that Mannanase, batch PPE6432 at 105.8 mg enzyme concentrate dry matter/L had no effect on the survival of rainbow trout over a 96 -hr period in semi-static conditions.
It is concluded that the LC50 of Mannanase, batch PPE6432 to rainbow trout is greater than 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L). The no observed effect concentration is concluded to be the highest concentration tested 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L).
Reference
Description of key information
Under the conditions of the test, Mannanase, batch PPE6432 was not found to be acutely toxic to rainbow trout (Oncorhynchus mykiss). Consequently, the 96-hour LC50 value for mannanase could not be calculated and must be > 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L). The "no-observed effect concentration" was the highest concentration 105.8 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L).
Key value for chemical safety assessment
Additional information
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.