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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted to internationally recognised test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3,6-tetrahydrophthalimide
EC Number:
201-602-8
EC Name:
1,2,3,6-tetrahydrophthalimide
Cas Number:
85-40-5
Molecular formula:
C8H9NO2
IUPAC Name:
2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione
Details on test material:
- Name of test material (as cited in study report): THPI D4
- Physical state: Solid
- Analytical purity: 97.91%
- Lot/batch No.: STI4208324
- Expiration date of the lot/batch: 2009-11-21
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, protected from light and humidity

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: Direct sampling
- Sample storage conditions before analysis: 6 Deg C +/- 2 Dec C

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Direct addition to dilution water (medium) followed by ultrasonification for 10 minutes
- Controls: Diution water (medium)
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None used
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None observed

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain: STRAUS (Clone 5)
- Source: Institut fur Wasser, Boden und Lufthygiene
- Age at study initiation (mean and range, SD): 2-24 hours
- Method of breeding: Colony maintained at test facility in 2-3 L capacity glass vessels with 1.8 L Elendt M4 medium in an incubator at 20+/- 2 Dec C and 16 hours illumination/day. Fed 5 x weekly with unicellular green algae
- Feeding during test
- Food type: None


ACCLIMATION
- Acclimation period: Minimum of 2 hours
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: None

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
265 mg/L as CaCO3
Test temperature:
20 - 21 Dec C
pH:
7.50 - 7.98
Dissolved oxygen:
7.36 - 8.63 mg/L
Nominal and measured concentrations:
Nominal - 100 mg/L (97.9 mg/L when corrected for purity)
Measured - at test start (0 hours) 91.8 mg/L; at test end (48 hours) 89.5 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 50mL capacity glass beakers
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Glass, 4 cm ID x 7 cm, fill volume 20 mL
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: As specified in Council Refgulation 440/2008 Method C2, Appendix 2
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light : 8 hours dark / day
- Light intensity: Maximum 0.02 E.m-2/second


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation assessed 24 and 48 hours after start of exposure


TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable (limit test)
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes - lack of effects at 100 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: None observed
- Mortality of control: None
- Other adverse effects control: None observed
- Abnormal responses: None observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None observed
- Effect concentrations exceeding solubility of substance in test medium: No
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50: 24 hour EC50 = 1.66 mg/L (95% confidence interval 1.50 - 1.83 mg/L
:

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance has no effect on Daphnia following 48 hours exposure at a concentration of 100 mg/L
Executive summary:

The substance has no effect on Daphnia following 48 hours exposure at a concentration of 100 mg/L