1,4-dioxacycloheptadecane-5,17-dione

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

1996

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

This study was performed according to OECD Guideline 211 with GLP statement. However, this study is invalid based on the high pH values in the control and in the maximum test concentration, and the rapid degradation of the test substance. Chronic toxicity data of parent substance is not relevant. In addition, abnormal toxicity is observed in the third replicate.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

Part II (Draft 8/1995)

Deviations:

yes

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dioxacycloheptadecane-5,17-dione

EC Number:

203-347-8

EC Name:

1,4-dioxacycloheptadecane-5,17-dione

Cas Number:

105-95-3

Molecular formula:

C15H26O4

IUPAC Name:

1,4-dioxacycloheptadecane-5,17-dione

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): Ethylenbrassylat
- Analytical purity: see confidential data
- Lot/batch No.: see confidential data

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
not relevant

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

sampling was performed on days 2, 7, 10 and 12

Test solutions

Vehicle:

no

Details on test solutions:

For the preparation of the stock solution, the test substance was weighted and mixed in the water. An Ultra-Turrax was used during 60 seconds at the speed of 8000 rotations/minute.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna Straus
- Strain/clone: Clone of the "Bundesgesundheitsamtes Berlin"
- Source: Own grow of the Bayer AG laboratory
- Age of parental stock (mean and range, SD): parthogenetic females
- Feeding during test: test
- Food type: Scenedesmus subspicatus
- Amount: between days 0-7: 0.1 mg TOC value /parent animal/day; between days 8-10, 0.2 mg TOC value /parent animal/day

ACCLIMATION
- Acclimation period: no details

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Post exposure observation period:

no

Test conditions

Hardness:

no data

Test temperature:

20+-2°C, see table 6.1.4/1 in "Any other information on materials and methods incl. tables".

pH:

See table 6.1.4/2 in "Any other information on materials and methods incl. tables".

Dissolved oxygen:

See table 6.1.4/3 in "Any other information on materials and methods incl. tables".

Salinity:

Not applicable

Nominal and measured concentrations:

See table 6.1.4/7 in "Any other information on results incl. tables".

Details on test conditions:

TEST SYSTEM
- Test vessel: Karlsruher flask
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 320 mL test medium
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): semi static
- Renewal rate of test solution (frequency/flow rate): renewal on Mondays, Wednesdays and Fridays
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- No. of vessels per vehicle control (replicates): 5
- Biomass loading rate: no data

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium according to Elendt Version of the BGA (1992)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light 8 h dark
- Light intensity: 12 µE/ m2.s was measured to correspond to a light strength of < 800 Lux.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: no data

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 0.165 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

immobilisation

Effect concentrations 2

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

0.088 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Effect concentrations 3

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

0.165 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

- Mortality of parent animals: only at the tested concentration of 0.4 mg/L. 1 animal/5 died in one replicate and 2 animals/5 died in another replicate
See tables in "Any other information on results incl. tables".

Results with reference substance (positive control):

no reference substance used

Reported statistics and error estimates:

no data

Any other information on results incl. tables

Table 6.1.4 /4: Number of surviving offsprings and parents

Tested concentration	Replicate 1			Replicate 2			Replicate 3
	Sum of young s	Mean number of Parents	Reproduction rate in 21 days	Sum of young s	Mean number of Parents	Reproduction rate in 21 days	Sum of young s	Mean number of Parents	Reproduction rate in 21 days
Control	686	5	137.2	671	5	134.2	780	5	156
0.05	637	5	127.4	675	5	135	705	5	141
0.1	615	5	123	686	5	137.2	634	5	126.8
0.2	686	5	137.2	607	5	121.4	642	5	128.4
0.4	579	5	115.8	678	5	135.6	572	4.8	119.2

Table 6.1.4 /5: Number of dead offsprings after 21 days 

Tested concentration	Replicate 1	Replicate 2	Replicate 2
Control	0	0	0
0.05	0	0	0
0.1	9	9	21
0.2	10	15	12
0.4	17	18	74

Table 6.1.4 /6: Mean number of offsprings after 21 days with standard deviation and variation coefficient

Tested concentration	Mean reproduction rate	Standart deviation	Variation coefficient
Control	142.5	11.8	8.3
0.05	134.5	6.8	5.1
0.1	129	7.4	5.7
0.2	129	7.9	6.1
0.4	123.5	10.6	8.6

Table 6.1.4 /7: Measured concentrations of test substance

Date	Concentration of the test substance
	Nominal value	Measured value	% of nominal value
24.04.96 (fresh solution)	Control	<0.001	---
24.04.96	0.05	0.063	126.0
24.04.96	0.1	0.128	128.0
24.04.96	0.2	0.245	122.5
24.04.96	0.4	0.480	120.0
26.04.96 (48h old solution)	Control	0.053 (+)	-
26.04.96	0.05	-	-
26.04.96	0.1	0.018 (+)	-
26.04.96	0.2	0.024 (+)	-
26.04.96	0.4	0.052 (+)	-
03.05.96 (fresh solution)	Control	< 0.001	-
03.05.96	0.05	0.038	76.0
03.05.96	0.1	0.082	82.0
03.05.96	0.2	0.157	78.5
03.05.96	0.4	0.291	72.8
06.05.96 (72h old solution)	Control	< 0.001 (*)	-
06.05.96	0.05	< 0.001 (*)	-
06.05.96	0.1	< 0.001 (*)	-
06.05.96	0.2	< 0.001 (*)	-
06.05.96	0.4	< 0.001 (*)	-
06.05.96 (fresh solution)	Control	< 0.001	-
06.05.96	0.05	0.045	90.0
06.05.96	0.1	0.099	99.0
06.05.96	0.2	0.192	96.0
06.05.96	0.4	0.366	91.5
08.05.96 (48h old solution)	Control	< 0.001	-
08.05.96	0.05	< 0.001 (*)	-
08.05.96	0.1	< 0.001 (*)	-
08.05.96	0.2	< 0.001 (*)	-
08.05.96	0.4	< 0.001 (*)	-

(*)Values lying below the limit of quantification (< 0.001 mg/L) are used as 0.0005mg/L in the assessment

(+) there could have been a measure mistake at these values. To get the arithmetic mean, the results of the 03.05.96, 06.05.96 and 08.05.96 were used.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the test, the 21-d NOEC for Daphnia magna exposed to the test substance is 0.088 mg/L based on reproduction effects.

Executive summary:

The 21-day long term toxicity of the test substance to Daphnia magna was studied under semi-static conditions, according to OECD Guideline 211 with GLP statement. Daphnids were exposed to control water and solvent, and test chemical at nominal concentration of 0, 0.05, 0.1,0.2, and 0.4 mg/L. Test medium was renewed every 2 days except on the weekends when 3 days were left. Measured concentrations were calculated as an arithmetic mean. Mortality of adults and number of offsprings were recorded every day and before renewal of the test media. The 21 -day NOEC was 0.088 mg/L (based on arithmetic mean measured concentration). The lowest observed effect concentration based on immobilization was 0.165 mg/L (based on mean measured concentration)

This study is invalid based on the high pH values in the control and in the maximum test concentration, and the rapid degradation of the test substance. Chronic toxicity data of parent substance is not relevant. In addition, abnormal toxicity is observed in the third replicate.

 

Results Synopsis

 

Test Organism Age : -

Test Type : semi-static

21 days-NOEC = 0.088 mg/L

21 days-LOEC = 0.165 mg/L

Endpoint(s) Effected: mobility and reproduction