Adipic acid, ammonium salt

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

Adipic acid, ammonium salt

EC Number:

242-809-3

EC Name:

Adipic acid, ammonium salt

Cas Number:

19090-60-9

Molecular formula:

C6H10O4.xH3N

IUPAC Name:

ammonium 5-carboxypentanoate

Test material form:

solid: crystalline

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

For determination of the test item concentrations, four replicate samples (3 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test.

Test solutions

Vehicle:

yes

Remarks:

water

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Test System (Test Animals)

Species and strain: Daphnia magna (Straus)
Origin: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection)
2100 Gödöllő, Kotlán S. u. 3. Hungary
Breeding: The Daphnia are bred in the Laboratory of TOXI-COOP ZRT.
Number of animals: Twenty animals in both groups (concentration and untreated control), divided into 4 concurrent batches (5 animals per batch).
Age of animals: Less than 24 h old at the beginning of the test.
Sex: Female
Animal health: Apparently healthy animals were used in this test with a known history
Acclimatization: Test animals were bred under similar (or the same) conditions as that used during the exposure period (holding water, temperature, background colour etc.), therefore additional acclimatisation before the test was not necessary. Brood daphnids were maintained in dilution water at the test temperature for at least 48 hours prior to the start of the test.
Food and Feeding: The Daphnia were fed with concentrated algal suspension of Raphidocelis subcapitata during the holding. Test animals were not fed during the exposure.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Hardness: The reconstituted water (ISO medium) had an approximate theoretical total hardness of 249 mg/L (as CaCO3).

Test temperature:

Temperature: The test temperature was in the range of 20.8 – 21.1 °C measured in the test vessels during the test. The additionally measured ambient temperature within the climate chamber was between 20.4 – 21.5 °C.

pH:

pH: The pH of the test solution was not adjusted and not varied by more than 1.5 units in any one test group. The pH was in the range of 7.82 – 8.28 during the test.
Remark: The data of pH, dissolved oxygen concentration and temperature measured during the test are detailed in Appendix I; Tables 3-5.

Dissolved oxygen:

Oxygen Concentration: The dissolved oxygen concentration was in the range of 7.26 – 8.06 mg/L during the test.

Salinity:

na

Conductivity:

na ( reconstituted water ISO medium)

Details on test conditions:

Table 3: Test Item concentration measured at the start
Nominal concentration
mg/L Mean of the measured concentrations
mg/L Measured concentration in % of the nominal
100 98.1 (RSD: 1 %) 98
Control below quantitation limit -

Table 4: Test Item concentration measured at the end
Nominal concentration
mg/L Mean of the measured concentrations
mg/L Measured concentration in % of the nominal
100 106.4 (RSD: 1 %) 106
Control not detected -

Reference substance (positive control):

yes

Remarks:

Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 100 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test item Ammonium Adipate had no toxic effect at 100 mg/L concentration (i.e. limit test concentration) on Daphnia magna; the EC50 and the LOEC are higher than 100 mg/L.
All validity criteria were met. The results are based on nominal test item concentrations.

Summary of the Biological Endpoints (same a Table 1)
Endpoint Concentration [mg/L]
48 h-EC10 > 100
48 h-EC20 > 100
48 h-EC50 > 100
48 h-NOEC 100
48 h-LOEC > 100

Executive summary:

 

Test item:	Ammonium Adipate(Lot No.:N118031457)
Test species:	Daphniamagna(Straus)
Dilution water:	ISO medium, prepared inthe laboratory of TOXI-COOP ZRT.
Concentrations:	Limit test; using a single concentration of 100 mg/L; concurrent control ran.
Test design:	Twenty animals, divided into four groups (glass beaker; volume app. 50 mL) of five animals each were exposed to the test concentration or run as control for 48 hours in a static test. The immobility or mortality of theDaphniais determined by visual observation after 24 and 48 hours of exposure.
Analytics:	Concentration of the test item were determined usingHPLC-UV methodatthe start and at the end of the test.
Endpoints:	EC10, EC20, EC50, NOEC and LOEC for 48h test period.
Statistics:	Statistical analysis was not necessary; endpoints were determined directly from the raw data.
Validity:	All validity criteria were met and therefore the study can be considered as valid (see section 8.1)
Results:	There was no immobilisation observed in twenty daphnids exposed to each test item treated and control group. Further no abnormal behaviour or appearance of test animals was noted. Biological results are based on the nominal test item concentrations. The biological endpoints are summarised below in Table 1.

 

 

Table 1:Summary of the Biological Endpoints

Endpoint	Concentration [mg/L]
48 h-EC10	> 100
48 h-EC20	> 100
48 h-EC50	> 100
48 h-NOEC	100
48 h-LOEC	> 100