Amines, polyethylenepoly-

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

11-07-1990 to 01-08-1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other:

Remarks:

The study was peformed under GLP and according to a clear guideline. No analysis has been performed, this is the major restriction of the study.

Justification for type of information:

Please refer to the read-across justification attached to IUCLID section 13

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: OECD 202 part II ( at least 14 days)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
a stock solution was prepared by adding 200 mg/L test substance to the test medium. The stock solution was stirred for 1 h using a magnetic stirrer. The test solutions were prepared by diluting the stock solution.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: klone obtained from Bundesgesundheitsam, Berlin, Germany, reared at testing facility
- Age of parental stock (mean and range, SD): 6-24 h

- Feeding during test: yes
- Food type: green algae Scenedesmus subspicatus
- Amount and Frequency:
Day 0-1: 1.7E+6 cells
Day 2-3: 2.0E+6 cells
Day 4-5: 2.7E+6 cells
Day 6-7: 3.3E+6 cells
Day 8-20:: 6.7E+6 cells

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

18.0 - 20.8 ºC

pH:

control: 7.7 - 8.7
treatments: 7.8 - 8.9

Dissolved oxygen:

8.2 - 11.7 mg/L

Nominal and measured concentrations:

Nominal test substance concentrations: 1.0, 3.2, 10, 32, 100 mg/L

DOC Analysis determined DOC values of >62 - >100 mg/L

Details on test conditions:

16h light/8 dark. The organisms will be held in 250 ml jars and each will contain 5 animals; in eight parallels. Total number per concentration thus is 40. TEST SYSTEM
- Test vessel: glass beakers (diameter 9.5 cm, height: 11.5 cm)
- Fill volume: 250ml
- Aeration: none
- Renewal rate of test solution (frequency/flow rate): every second day
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 8
- No. of vessels per control (replicates): 8


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: test medium acc. to Elendt (1990)


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16:8 h day-night regime
- Light intensity: 60 - 80 µS/m²s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortalitiy and number of offspring at days: 0, 2, 5, 7, 9, 12, 14, 16, 19 and 21

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 3.2 - < 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

immobilisation

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

EC10

Effect conc.:

1.9 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: re-calculated using Toxcalc 5.0

Details on results:

The validity criteria of 60 juvenils per adult were not met in control replicates 2 and 8.

Validity criteria fulfilled:

yes

Conclusions:

The EC50 values (immobilisation and reproduction) were determined to be 3.2-10 and 10 mg/L, respectively. The study was peformed under GLP and according to a clear guideline. No analysis has been performed and that is the major restriction of the study. This will limit the use of the data when looking at the bioavailable fraction of the test substance. The reviewer calculated an EC10, based on the available raw data with the use of toxcalc 5.0..

Executive summary:

The EC50 values (immobilisation and reproduction) were determined to be 3.2-10 and 10 mg/L, respectively. the test was done according to the OECD 202, part II guideline (1984). Test was done under GLP and is valid.

Description of key information

OECD 202 part II, Daphnia magna: EC10 of 1.9 mg/L (nominal, recalculated) based on reproduction rate (read across).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

1.9 mg/L

Additional information

Experimental data on the chronic toxicity of Amines, polyethylenepoly (PEPA) to aquatic invertebrates are not available. Therefore, read-across to the structural analogue substance Triethylenetetramine linear, cyclic and branched (TETA; CAS 90640-67-8) was conducted. For details on the read-across approach please refer to the analogue justification provided in IUCLID section 13.

The long-term toxicity of the source substance TETA was investigated in a study following OECD 202 part II (at least 14 days). Daphnia magna were exposed to the test substance for 21 days in a semi-static test system. The tested nominal exposure concentrations were 1.0, 3.2, 10, 32 and 100 mg/L. After an exposure period of 21 days an EC50 of >3.2 - <10 mg/L based on the mobility of the parental animals was recorded. The study report documented an EC50 (21 d) of >10 mg/L (nominal) based on the reproduction rate of the test animals. Using the raw data an EC10 of 1.9 mg/L was determined via interpolation (software toxcalc 5.0).