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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
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 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
1984
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 were prepared by adding a volume of mannanase (1.127 mL) to a volumetric flask (1L) and bringing to volume with Daphnia medium. The flasks were gently shaken to ensure dispersion/solubility. Aliquots of 100 mL were taken from the volumetric flask and dispersed into four test tanks. Five Daphnia were added to each tank within 30 min of preparation of the test solutions. Daphnia were transferred (by means of a wide bore glass pipette) to freshly
prepared test solutions at 24 h.
- Controls: Medium
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia Magna (Water flea)
- Age at study initiation (mean and range, SD): between 6 and 24h
- Method of breeding: Daphnia were bred within the laboratory by acyclical parthenogenesis. Daphnia cultures were fed on a diet of axenic cultures of Selenastrum capricornutum.
- Feeding during test: no


Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
198-204 mg/L as CaCO3
Test temperature:
20.5-21.3°C
pH:
7.52-8.07
Dissolved oxygen:
61.4 - 88.8 % ASV (air saturation value)
Nominal and measured concentrations:
nominal: 0 and 105.8 mg mg enzyme concentrate dry matter/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass crystallising dishes
- Type (delete if not applicable): covered with perspex lids
- Material, size, fill volume: glass, 200 mL capacity, 100 mL volume
- Aeration: no, covered with perspex lids.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M7 medium prepared with deionised water
- Conductivity:497-548 µS
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Daphnia were considered immobile if no movement was observed within 15 seconds following gentle agitation of the test vessel. The numbers of immobile Daphnia were recorded at 24 and 48 hours after the start of the study.

Reference substance (positive control):
no
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 105.8 mg/L
Nominal / measured:
nominal
Conc. based on:
other: TOSenzyme concentrate dry matter
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
105.8 mg/L
Nominal / measured:
nominal
Conc. based on:
other: enzyme concentrate dry matter
Basis for effect:
mobility
Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the test, Mannanase, batch PPE6432 was not found to be acutely toxic to Daphnia magna at a nominal concentration of 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 Daphnia magna was assessed by conducting a limit test at a nominal concentration of 105.8 mg enzyme concentrate dry matter/L of medium. The study was conducted over a 48-hr period under semi-static exposure conditions, with the test solutions renewed at 24 hours.

The study was conducted in accordance with EC (1992) Guideline C2 and the OECD (1984) Guideline for Testing of Chemicals No. 202.

The nominal concentrations of Mannanase tested were 0 and 105.8 mg enzyme concentrate dry matter/L. The test medium was prepared in Elendt M4 medium by the direct addition of the test substance to the dilution medium. Water quality parameters (pH, temperature, conductivity and dissolved oxygen) were measured at the beginning and at 24h intervals at each test concentration. All test solution parameters remained within acceptable limits throughout the duration of the test.

Over the duration of the study one immobile Daphnia was observed at 105.8 mg enzyme cocnentrate dry matter/L. This immobilisation is not considered significant. No other immobile Daphnia were recorded during the study period. The results indicate that Mannanase at 105.8 mg enzyme cocnentrate dry matter/L is not toxic to Daphnia magna over a 48h period in semi-static conditions.

It is concluded that the 48-hr EC50 of Mannanase, batch PPE6432 to Daphnia magna is greater than 100 mg enzyme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L) under the conditions of the test. The No Observed Effect Concentration (NOEC) is concluded to be 105.8 mg enyzme concentrate dry matter/L (equivalent to 55.5 mg active enzyme protein/L), which was the highest concentration tested.

Description of key information

Under the conditions of the test, Mannanase, batch PPE6432 was not found to be acutely toxic to Daphnia magna at a nominal concentration of 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