Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
31 December 1991 and 2 January 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to GLP and internationally accepted test guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): dipentaerythritol

- Substance type: white powder
- Physical state: solid
- Analytical purity: 96.2%
- Impurities (identity and concentrations): mono-pentaerythritol 2.8%, tri-pentaerythritol 0.51%

- Purity test date: Received on 2 Sept 1991
- Lot/batch No.: 9404
- Expiration date of the lot/batch: 2 sept 1993

- Stability under test conditions: Verified by chemical analysis.
- Storage condition of test material: in original container at room temperature in darkness.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: control, 100 mg/L
- Sampling method: duplicate water samples were taken from the control and test replicates (R1 & R2 pooled and R3 & R4 pooled) at 0 and 48 hours.
- Sample storage conditions before analysis: The samples were stored frozen at -20°C until despatched to the sponsor for analysis.

Test solutions

Vehicle:
no
Details on test solutions:
Prepared by direct dispersion in water with the aid of ultrasonic disruption.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: daphnia magna straus
- Source: Laboratory culture originating from a strain supplied by IRChA, France
- Age at study initiation (mean and range, SD): first instar

- Method of breeding: parthenogenesis; gravid adults were isolated 24 hours prior to initiation of the test. young daphnids produced overnight were used for testing.


Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
150 - 200 mg/L CaCO3.
Test temperature:
21°C
pH:
7.1
Dissolved oxygen:
8.6-8.9 mgO2/L
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal: 100 mg/L; Measured: 92mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass, 200 ml test solution
- Aeration: none
- No. of organisms per vessel:10
- No. of vessels per concentration (replicates):4
- No. of vessels per control (replicates):2
- Biomass loading rate: 20 mL test solution per organism


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated by passage through activated carbon, softened by reverse osmosis and "aged" by recirculation through a gravel filter bed.


OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 hr dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobilisation


Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Applicant's summary and conclusion

Conclusions:
Daphnia magna were exposed to a nominal exposure concentration of 0 and 100 mg/L dipentaerythritol for 48 hours under static conditions. The mean measured concentration of the 100 mg/L test treatment was 92 mg/L which indicated that the test medium had been adequately prepared, as the concentration was within +/- 20% the results of the study are based on the nominal exposure concentration. No immobility was observed during the test therefore, the 48 hr EC50 was >100 mg/L, the corresponding no-observed effect concentration (NOEC) was observed to be 100 mg/L.
Executive summary:

Daphnia magna were exposed to a nominal exposure concentration of 0 and 100 mg/L dipentaerythritol for 48 hours under static conditions. The mean measured concentration of the 100 mg/L test treatment was 92 mg/L which indicated that the test medium had been adequately prepared. As the measured concentration was within +/- 20% of the nominal concentration the results of the study are based on the nominal exposure concentration. No immobility was observed during the test therefore, the 48 hr EC50 was >100 mg/L, the corresponding no-observed effect concentration (NOEC) was observed to be 100 mg/L.