Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1999
Reference Type:
secondary source
Title:
Phthalimide - CAS No: 85-41-6
Author:
OECD SIDS
Year:
2005
Bibliographic source:
SIDS Initial Assessment Report for 20th SIAM, UNEP Publications

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Phthalimide, purchased from Wako Pure Chemical: purity >99.0%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source: National Institute for Environmental Studies (Japan)
- Pretreatment of parent: 2-3 weeks
- Age at study initiation: less than 24 h old

ACCLIMATION
- Acclimation period: yes
- Acclimation conditions: same as test
- Type and amount of food: 0.1-0.2 mgC/day/daphnia

Study design

Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
21 d

Test conditions

Hardness:
238-249 mg/l as CaCO3
Test temperature:
19.9 - 20.9 °C
pH:
6.8 - 7.4
Dissolved oxygen:
7.3 - 8.6 mg/l
Nominal and measured concentrations:
concentration (nominal): 0, 2.4, 3.8, 6.1, 9.8, 15.6, 25.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- glass vessel, 100 ml net volume with 80 ml solution
- Aeration: none
- Renewal rate of test solution: 3 times a week
- Feeding during test: Chlorella regularis, 0.1-0.2 mgC/day/daphnia
- No. of organisms per vessel: 1 daphnia
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): no data

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Elendt M4 (in accordance with OECD TG211 Annex 2)
- pH: 7.0
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16h-8h light-dark cycle by room light
- Light intensity: no data
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
15.8 mg/L
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
7.6 mg/L
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
13.3 mg/L
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
other: 21day LC50
Effect conc.:
17.4 mg/L
Basis for effect:
other: mortality of parent daphnid
Results with reference substance (positive control):
Potassium dichromate (48hr EC50 = 0.90 mg/L)

Any other information on results incl. tables

CONCENTRATIONS
nominal measured concentration (mg/l) (% of nominal)
concentration 0day 2day 7day 9day 14day 16day 21day
(mg/L) new old new old new old mean
-----------------------------------------------------------
control <0.1 <0.1 <0.1 <0.1 <0.1 <0.1
2.4 1.6 0.9 1.7 0.9 1.9 1.0 1.3
(66.7) (37.5) (70.8) (37.5) (79.2) (41.7) (53.8)
3.8 2.4 1.3 2.7 1.4 3.0 1.5 2.0
(63.2) (34.2) (71.1) (36.8) (78.9) (39.5) (52.6)
6.1 3.5 2.2 4.4 2.3 4.8 2.5 3.2
(57.4) (36.1) (72.1) (37.7) (78.7) (41.0) (52.5)
9.8 5.5 3.7 7.0 3.5 7.7 4.1 5.1
(56.1) (37.8) (71.4) (35.7) (78.6) (41.8) (52.0)
15.6 8.9 6.1 8.4 4.4 12.3 6.8 7.6
(57.1) (39.1) (53.8) (28.2) (78.8) (43.6) (48.7)
25.0 13.7 10.7 18.3 8.9 19.8 10.8 13.3
(54.8) (42.8) (73.2) (35.6) (79.2) (43.2) (53.2)
-----------------------------------------------------------
rem. new = fresh solution
old = expired solution
mean = time-weighted mean during 21 days
As the half-life of this substance in water is 56.7 h at 25 °C and pH 7 (See section 3.1.2), almost all measured concentrations were much lower than the nominal ones. Therefore, time-weighted mean measured values were used for calculations.

EFFECTS
21day LC50 = 17.4 mg/l (95% confidendential: 8.8-1315 mg/l)
21day EC50 = 15.8 mg/l (95% confidendential: 13.6-19.4 mg/l)
21day NOEC = 7.6 mg/l
21day LOEC = 13.3 mg/l

CUMULATIVE NUMBER OF DEAD PARENTAL DAPHNIA AND THE MORTALITY AFTER 21 DAYS
measured concent- number of mortality
ration (mg/l) dead parent %
----------------------------------------------------------
control 0 0
1.3 2 20
2.0 0 0
3.2 0 0
5.1 1 10
7.6 1 10
13.3 7 70
----------------------------------------------------------

TIME (DAY) TO FIRST BROOD PRODUCTION
measured concent- mean
ration (mg/l) (day)
-----------------------------------------
control 8.3
1.3 7.1
2.0 8.2
3.2 7.6
5.1 7.2
7.6 7.6
13.3 7.9
-----------------------------------------

MEAN CUMULATIVE NUMBER OF JUVENILES PRODUCED PER ADULT DURING 21 DAYS EXPOSURE
measured concent- mean (mumber
ration (mg/l) of juveniles)
-------------------------------------------------
control 148.8
1.3 148.4
2.0 138.3
3.2 138.7
5.1 145.4
7.6 140.8
13.3 68.0
-------------------------------------------------

Applicant's summary and conclusion

Conclusions:
The EC50 (21 days reproduction) for Daphnia magna is 15.8 mg/l.
The NOEC (21 days reproduction) for Daphnia magna is 7.6 mg/l.
The LOEC (21 days reproduction) for Daphnia magna is 13.3 mg/l.