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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
19 February 1997 – 12 March, 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: OECD TG 202 (1984)
Version / remarks:
Daphnia sp., Acute Immobilisation and Reproduction Test
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SAMPLING
- Storage method: The test substance was stored in a sample storage cabinet, at room temperature and away from light.
- Verification of the test substance and stability under the storage conditions: Measurements of the infrared absorption spectrum, NMR spectrum and gas chromatography analysis of the supplied test substance were performed. The
characteristic peaks of the test substance were noted and its purity was confirmed. At the end of the study, the same measurements/analyses were performed, spectrum and gas chromatograph results compared. There were no changes. Therefore, it was confirmed that the test substance was stable during storage in the sample storage cabinet at our Research Institute.
Analytical monitoring:
yes
Details on sampling:
SAMPLING
1.5 ml of test water was collected from each beaker in both the control and the concentration group (each test vessel) on before and after water renewal. Sampling of fresh test solution was conducted immediately at the start of testing (day 0), and on days 7 and 19. Sampling of old test solution was conducted at days 2, on days 9 and 21.
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 0.4 wt% solution of the test substance was added to the dilution water to prepare the required volume of test solution. The control compartment was established with dilution water only. 1 concentration compartment consisted of 4 test vessels, each test vessel containing 400 ml of test solution. Condition of the test solution (external appearance etc.) was recorded. No opacity or sedimentation was observed.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: the breed stock had been obtained from the National Institute for Environmental Studies, and successively bred in the Research Institute
- Age of parental stock (mean and range, SD): not older than 24 hours
- Feeding during test: yes
- Water temperature: 20 ± 1°C.
- Light: Indoor lighting, 16 hours light/8 hours dark.
- Food: Chlorella vulgaris
- Food volume supplied: Chlorella vulgaris 0.1 – 0.2 mgC (organic carbon content)/day per 1 daphnid

ACCLIMATION
- Acclimation period: 22 days
- Acclimation conditions (same as test or not): yes
- Type, amount of food, frequency: Chlorella vulgaris 0.1 – 0.2 mgC (organic carbon content)/day per 1 daphnid
- Health during acclimation (any mortality observed): few dead individuals and no dormant eggs or males

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Method of breeding daphnids to obtain test young: Healthy adult female daphnids from the current generation of stock that were visually healthy and with a brood pouch of sufficient size were transferred to designated beakers, and then the young produced the following day were divided into separate beakers. These young daphnids became the parents for the test specimens and were acclimatised under the conditions detailed below for 22 days. In order for them to mature and reproduce, the young were removed at least once a week. The day prior to exposure, the young were removed and the young produced on the following day were used in the study. There were few dead individuals and no dormant eggs or males had been produced.

- Breeding water: Dilution water (acc. to the guideline).
- Breeding density: 20~50 individuals/L breeding water (less than 25 individuals/L for maturing individuals).
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
no data
Test temperature:
20.1-20.8°C
pH:
7.0-7.8
Dissolved oxygen:
6.02-9.50
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured recovery: 64.1 - 92.5 %; mean measured concentration: 85 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 500 ml capacity glass beakers
- Fill volume: 400 ml
- Type (delete if not applicable): open
- Renewal rate of test solution (frequency/flow rate): water change 3 times a week
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium, acc. to the guideline (7.6); when using the dilution water, it was checked for residual chlorine by O-toluidine assay. Total hardness was not measured.The pH of the dilution water was 7.6.
- Culture medium different from test medium: no
- Intervals of water quality measurement:
Water temperature: measurements were taken weekly at the time of water exchange, for all compartments (i.e. each test vessel).
Dissolved oxygen content (D.O.): measurements were taken weekly at the time of water exchange, for all compartments (i.e. each test vessel).
pH: measurements were taken weekly at the time of water exchange, for all compartments (i.e. each test vessel).

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Indoor lighting, 16 hours light/8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Daphnia magna observations (Parental daphnids): mortality, immobility, abnormalities in external appearance; daily
- Daphnia magna observations (Juveniles produced): day of first progeny, number of offspring, living and dead young, aborted eggs and dormant eggs; at time of water renewal

TEST CONCENTRATIONS
The effect concentration (EC50) of the 48-hour acute immobility in Daphnia magna was above 1000 mg/L, so a limit test was set at 100 mg/L only (control compartment and 100 mg/L concentration compartment).

TEST PERFORMANCE
Water temperature, dissolved oxygen concentration (D.O.) and pH were measured, after which the sample daphnids were introduced and the time of their introduction set as the start of the exposure period. The daphnids were introduced using a wide-barrelled glass pipette. The total volume of breeding water within the pipette at this time was within 1% of the volume of the test solution. After this, the daphnids were transferred to new test solution at each water exchange, and bred for 21 days. During the exposure period, a set quantity of food was given.

- Daphnia magna observations (Parental daphnids)
Numbers of deaths were counted daily. Also, if any visible abnormalities were found (immobility, abnormalities in external appearance) these were recorded. After counting, any dead parent individuals would be removed. When transferring parental daphnids to new test solution at the time of water exchange, care was taken to ensure that, as far as possible, old test solution was not introduced.

- Daphnia magna observations (Juveniles produced)
At the time of each water change, the vessels were checked for living and dead young, aborted eggs and dormant eggs. Live young were removed after counting.
The first day that young were produced was recorded as the date of first brood production.
Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 85 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
> 85 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
> 85 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: parental Daphnia
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
> 85 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: parental Daphnia
Details on results:
TREATMENT GROUP
Parental daphnia death numbers and mortality rate
No parental Daphnia deaths were observed in the test compartment (85.0 mg/L) so half lethal concentration (LC50) was > 85 mg/L.

Mean cumulative number of juveniles
There was no significant difference with the control compartment for mean cumulative number of juveniles in each test vessel in the test compartment (85.0 mg/L), so 50% reproduction inhibition concentration (ErC50) and the no observed effect concentration (NOECr) was > 85.0 mg/L. The mean cumulative number of juveniles per parent individual in the treatment group was 45.38 compared to 42.68 of the control.

CONTROL
Parental daphnia death numbers and mortality rate
The mortality rate of parental Daphnia in the control compartment was 0% at the end of the exposure period, satisfying the established test criterion of being below 20%. No deaths at all were observed in parental Daphnia in either the control compartment or concentration compartment. Therefore, the mortality rate of parental Daphnia in the concentration compartment with concentration of the test substance at 85.0 mg/L was 0%.

Day of first brood production
The day of first brood production from parental Daphnia in the control compartment was day 7-8, satisfying the established test criterion of within 9 days. In the 85 mg/L concentration compartment, day of first brood from parental Daphnia was day 7-9.

Mean cumulative number of juveniles
In the control the mean cumulative number of juveniles per parent individual was 42.68, satisfying the established test criterion of 40.

Production of dormant eggs
There were no dormant eggs in the control compartment or concentration compartments.
Results with reference substance (positive control):
For the integrated acute immobilisation testing (test performed acc. to outdated guideline 202; Daphnia sp., Acute Immobilisation Test and Reproduction Test” (1984)), a standard substance (potassium dichromate, pharmaceutical grade) 48-hour EiC50 derived established at 0.42 mg/L.
Reported statistics and error estimates:
Please see 'any other information on materials and methods'.

Results of the Control: Reproduction Test of Daphnia magna

    Time Total
Counts 2/20 2/21 2/22 2/23 2/24 2/25 2/26 2/27 2/28 3/1 3/2 3/3 3/4 3/5 3/6 3/7 3/8 3/9 3/10 3/11 3/12
No.   1d 2d 3d 4d 5d 6d 7d 8d 9d 10d 11d 12d 13d 14d 15d 16d 17d 18d 19d 20d 21d
1 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10  --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 --
Fl generation Live 0 0 0 0 0 0 0 3 8 --  -- 56 -- 43 -- 75   -- 156 -- 92 433
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.30 0.80 -- -- 5.60 -- 4.30 -- 7.50 -- -- 15.60 -- 9.20 43.30
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.30 1.10 1.10 1.10 6.70 6.70 11.00 11.00 18.50 18.50 18.50 34.10 34.10 43.30 --
2 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10  --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0  --
Fl generation Live 0 0 0 0 0 0 0 5 2 -- -- 165  -- 58   66 -- -- 84 -- 83 463
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.50 0.20 -- -- 16.50 -- 5.80 -- 6.60 -- -- 8.40 -- 8.30 46.30
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.50 0.70 0.70 0.70 17.20 17.20 23.00 23.00 29.60 29.60 29.60 38.00 38.00 46.30 --
3 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0- 0 0 0 --
Fl generation Live 0 0 0 0 0 0 11 -- 22 -- -- 22  -- 55 -- 83  -- -- 81 -- 111 385
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 1.10 -- 2.20 -- -- 2.20 -- 5.50 -- 8.30 -- -- 8.10 -- 11.10 38.50
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 1.10 1.10 3.30 3.30 3.30 5.50 5.50 11.00 11.00 19.30 19.30 19.30 27.40 27.40 38.50 --
4 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 --
F1 generation Live 0 .0 0 0 0 0 7 -- 14 -- -- 43  -- 82   79  --  -- 79 -- 122 426
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.70 -- 1.40 -- -- 4.30 -- 8.20 7.90 -- -- 7.90 -- 12.20 42.60
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.70 0.70 2.10 2.10 2.10 6.40 6.40 14.60 14.60 22.50 22.50 22.50 30.40 30.40 42.60 --

The time (days) to first brood: No. 1: 8 days, No. 2: 8 days, No. 3: 7 days, No. 4: 7 days

Results of the Treatment Group (mean meas. conc. 85 mg/L): Reproduction Test of Daphnia magna

                  Time                   Total
Counts 2/20 2/21 2/22 2/23 2/24 2/25 2/26 2/27 2/28 3/1 3/2 3/3 3/4 3/5 3/6 3/7 3/8 3/9 3/10 3/11 3/12
No.   ld 2d 3d 4d 5d 6d 7d 8d 9d 10d Ild 12d 13d 14d 15d 16d 17d 18d 19d 20d 21d
1 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10  --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 --
Fl generation Live 0 0 0 0 0 0 0 0 7 -- -- 59 -- 47 -- 67 -- -- 142 -- 89 411
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.70 -- -- 5.90 -- 4.70 -- 6.70 -- -- 14 -- 8.90 41.10
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.70 0.70 0.70 6.60 6.60 11.30 11.30 18.00 18.00 18.00 32.20 32.20 41.10 --
2 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 --
Fl generation Live 0 0 0 0 0 0 8 - 43 -- -- 72   96 -- 64 -- -- 72   53 408
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.80 - 4.30 -- -- 7.20 - 9.60 -- 6.40 -- -- 7.20 - 5.30 40.80
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.80 0.80 5.10 5.10 5.10 12.30 12.30 21.90 21.90 28.30 28.30 28.30 35.50 35.50 40.80  
3 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0` 0 0 0 0 --
Fl generation Live 0 0 0 0 0 0 0 0 13 -- -- 87 - 53 -- 163 -- -- 188 -- 98 602
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1.30 -- -- 8.70 - 5.30 -- 16.3 -- -- 18.8 -- 9.80 60.20
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1.30 1.30 1.30 10.00 10.00 15.30 15.30 31.60 31.60 31.60 50.40 50.40 60.20 --
4 P generation Live 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 --
Dead 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 --
F1 generation Live 0 0 0 0 0 0 0 0 3 -- -- 92 -- 53 -- 108 -- -- 84 -- 54 394
Reproductivity/P 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.30 -- -- 9.20 -- 5.30 -- 10.80 -- -- 8.40 -- 5.40 39.40
Cumulative reproductivity 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.30 0.30 0.30 9.50 9.50 14.80 14.80 25.60 25.60 25.60 34.00 34.00 39.40 --

The time (days) to first brood: No. 1: 9 days, No. 2: 7 days, No. 3: 9 days, No. 4: 9 days

Measured Concentrations of  1,4-Butanediol  during a 21-day Exposure of Daphnia magna under Semi-Static Test Conditions

Nominal
Concentration
(mg/L)
Measured concentration (mg/L) Percent of Nominal
 0 day new 7 days old Mean  0 day new 7 days old
Control <20   <20 - - -
100 91.6 92.5 92.0 91.6 92.5
         
Nominal
Concentration
(mg/L)
Measured concentration (mg/L) Percent of Nominal
7 day new 9 days old Mean 7 day new 9 days old
Control <20   <20 - - -
100 94 83.3 88.6 94.0 83.3
         
Nominal
Concentration
(mg/L)
Measured concentration (mg/L) Percent of Nominal
7 day new 9 days old Mean 7 day new 9 days old
Control <20   <20 - - -
100 86.1 64.1 74.5 86.1 64.1

new : freshly prepared test solutions

old : test solutions after 2 days exposure period

Time-weighted Mean of Measured Concentrations of 1,4-Butanediol during a 21-day Exposure of Daphnia magna under Semi-Static Test Conditions

Nominal  Time-weighted Mean Percent of Nominal
(mg/L)   (mg/L)   (%)
Control - -
100 85 85
Validity criteria fulfilled:
yes
Remarks:
acc. to OECD 202, 1984; see also overall remarks
Conclusions:
The 21-d NOEC (Daphnia magna, reproduction) is > 85 mg/L.
Executive summary:

1,4 -Butanediol was tested for effects on reproduction of Daphnia magna in a 21 -d semi-static study following OECD TG 211 (1984). A limit test with the nominal concentration of 100 mg/L was set up. Analytical verification of the test substance concentration revealed a mean measured concentration of 85 mg/L. No adverse effects were determined. Based on mean measured concentrations, the 21-d NOEC was > 85 mg/L. The study was considered reliable and adequate for the environmental hazard assessment.

Description of key information

21 -d NOEC(Daphnia magna, reproduction) > 85 mg/L (OECD 211, NITE, 1996)

Key value for chemical safety assessment

Additional information

Read-across approach: butane-1,4 -diol (source), butane-1,3 -diol (target) (see also Read-across justification in IUCLID section 13)

In the available key study, the source substance butane-1,4 -diol was tested for effects on reproduction of Daphnia magna in a 21 -d semi-static study following OECD TG 211 (1984, RL2). A limit test with the nominal concentration of 100 mg/L was set up. Analytical verification of the test substance concentration revealed a mean measured concentration of 85 mg/L. No adverse effects were determined. The determined 21 -d NOEC was > 85 mg/L (mean measured concentrations), which was derived for source and target substance (no conversion factor applied as source and target compound have the same molecular weight).