Nadide

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

Study period:

Jun.- Nov. 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Nadide

EC Number:

200-184-4

EC Name:

Nadide

Cas Number:

53-84-9

Molecular formula:

C21H27N7O14P2

IUPAC Name:

nadide

Constituent 2

Reference substance name:

b-Nicotinamide-adenine Dinucleotide II (nadide)

IUPAC Name:

b-Nicotinamide-adenine Dinucleotide II (nadide)

Details on test material:

- Molecular formula (if other than submission substance): C21H27N7O14P2
- Molecular weight (if other than submission substance): 663.44
- Analytical purity: 98%
- Other: off-white powder

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: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 hours from parental daphnids of more than 2 weeks old.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Details on test conditions:

- Test vessel: 100 ml, all-glass
- No. of organisms per vessel: 5 per vessel containing 80 ml test solution
- Light intensity: 16 hours photoperiod daily
- Test concentrations: 0.1, 1.0, 10 and 100 mg/l

Reference substance (positive control):

no

Remarks:

test medium without test substance or other additives

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

nadide did not induce acute immobilisation of Daphnia magna at the regulatory limit concentration, i.e. 100 mg/l after 48 hours of exposure (NOEC).

Executive summary:

Acute Toxicity Study in Daphnia magna with nadide.

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, the procedures were designed to meet the test methods of the CommissionRegulation (EC) No440/2008,Part C.2, 2008 and the ISO International Standard 6341, 1996.

The batch of nadide tested was a off-white crystalline powder with a purity of 98% and completely soluble in test medium at the concentrations tested.

A combined limit/range-finding test was performed. Preparation started with a concentration of 100 mg/l. No other treatment than vigorous shaking was needed to completely dissolve the test substance. The lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. The final test solutions were all clear and colourless.

Twenty daphnids per group (5 per vessel, 4 vessels) were exposed to a control and a concentration of 100 mg/l in a limit test. In addition, ten daphnids per group (5 per vessel, 2 vessels) were exposed to 0.1, 1.0 and 10 mg/l in a range-finding test. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test.

The measured concentration in the sample taken from the nominal concentration of 100 mg/l was in agreement with nominal and remained stable during the test.

Based on these results, the effect parameters were expressed in terms of analytically confirmed nominal concentrations.

The study met the acceptability criteria prescribed by the protocol and was considered valid.

nadide did not induce acute immobilisation of Daphnia magna at analytically confirmed nominal concentration of 100 mg/l after 48 hours of exposure (NOEC).

The 48h-EC₅₀was beyond the range tested, i.e. exceeded an analytically confirmed nominal concentration of 100 mg/l.