Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 December 1991 - 03 January 1992.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted 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 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
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 2 September 1991
- Lot/batch No.: 9404
- Expiration date of the lot/batch: 2 September 1993

- Stability under test conditions: ensured by daily renewal of test media and 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: 10, 18, 32, 56 and 100 mg/L
- Sampling method: duplicate water samples were taken
- Sample storage conditions before analysis: samples stored at -20°C until analysis by Sponsor.

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):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain:
- Source: Westacre Trout Farm, Norfolk, U.K.
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD4.8 cm (SD=0.5):
- Weight at study initiation (mean and range, SD): 1.99 g (SD=0.45)
- Method of breeding:
- Feeding during test
- Food type: commercial trout pellets
- Amount:
- Frequency: discontinued 24 hours prior to test


ACCLIMATION
- Acclimation period: 1 month (20 November 1991 - 30 December 1991).
- Acclimation conditions (same as test or not): Yes
- Type and amount of food:
- Feeding frequency:
- Health during acclimation (any mortality observed): 0% mortality 7 days prior to study

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
150-200 mg/L as CaCO3
Test temperature:
14 °C
pH:
7.1 - 7.2
Dissolved oxygen:
10.1 - 10.2 mgO2/L
Salinity:
not applicable
Nominal and measured concentrations:
Nominal: 10, 18, 32, 56 and 100 mg/L. Measured: 9.5, 17, 30, 53 and 93 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume: glass, 20 litres
- Aeration: via narrow bore glass tubes
- Renewal rate of test solution : daily renewal
- No. of organisms per vessel:10
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates):1
- Biomass loading rate: fish were placed in prepared test media at 1.0 g bodyweight/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated by passage through activated carbon and softened by reserved osmosis.


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:16 h light: 8 h dark
- Light intensity:


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Death is absence of i) respiratory movement and ii) response to physical stimulation

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
56 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: none reported
- Observations on body length and weight: none reported
- Other biological observations: increased pigmentation in two of ten fish at the highest dose level
- Mortality of control:none
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Rainbow trout were exposed to nominal exposure concentrations of 0, 10, 18, 32, 56 and 100 mg/L dipentaerythritol for 96 hours under semi-static conditions. Mean measured concentrations indicated that the test media had been adequately prepared and were within +/- 20%, therefore the results of the study are based on nominal exposure concentrations. No mortality was observed in any of the test concentrations, therefore, the 96 hr LC50 >100 mg/L. During the study 20% of the fish in the 100 mg/L treatment exhibited darkened pigmentation, therefore the no-observed effect concentration (NOEC) was observed to be 56 mg/L.
Executive summary:

Rainbow trout were exposed to nominal exposure concentrations of 0, 10, 18, 32, 56 and 100 mg/L dipentaerythritol

for 96 hours under semi-static conditions. Mean measured concentrations indicated that the test media had been adequately prepared and were within +/- 20%, therefore the results of the study are based on nominal exposure concentrations. No mortality was observed in any of the test concentrations, therefore, the 96 hr LC50 >100 mg/L. During the study 20% of the fish in the 100 mg/L treatment exhibited darkened pigmentation, therefore the no-observed effect concentration (NOEC) was observed to be 56 mg/L.