Carbamic acid, [(1S)-2-[(2-aminoethyl)amino]-1-[(4-ethoxyphenyl)methyl]ethyl]-, phenylmethyl ester, dihydrochloride

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Apr - Jun 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

23.9 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 11.6 - 49.1

Table 1: Cumulative immobilization (%) of Daphnia magna (0 = 20) after exposure to ZK 155546

Nominal concentration	Measured concentration of	24 hours	48 hours
of ZK 155546 (mg/L)	ZK 155546 (mg/L)
0 control (tap water)	0 control (tap water)	0	0
6.25	7.0 0 0	0	0
12.5	13.7	5	10
25	22.5	10	100
50	50.2	85	100
100	100.7	100	100

Validity criteria fulfilled:

yes

Conclusions:

The ECso/48 hours ofZK 155546 to Daphnia magna was calculated to be 23.9 mg/L [95% confidence limits 11.6 - 49.1] on the basis of TOC
measured concentrations. The highest concentration without effects was 7.0 mg/L.
Accordingly, ZK 155546 is harmful to Daphnia magna, since the EC50 was between 10 and 100 mg/L.

Executive summary:

The purpose ofthe study was to determine the acute toxicity (immobilization, EC50/48 hours) of Z-Triamin-Dihydrochlorid (ZK 155546) with Daphnia magna in order to evaluate the aquatic toxicity. ZK 155546 is an intermediate of the synthesis of Primovist. The study was conducted as a definitive test according to the guideline of the OECD, no 202.

20 juvenile Daphnia magna were used for each test solution of ZK 155546 and 20 for the tap water control. The Daphnia were exposed for aperiod of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours. For the preparation ofthe test solutions a suspension with a nominalloading of 111 mg/L was ultrasonified and then stirred for approximately 30 minutes each. This suspension was filtered through a glassfibre filter. The resulting solution was used for the preparation of the test solutions. The highest concentration had a nominal concentration of 100 mg/L obtained by dilution with tap water containing the daphnids, the further concentrations were obtained by dilutions of 1 :2, 1 :4, 1 :8, and 1 :16 with tap water. Additionally, a control solution was prepared with tap water without test material. Sampies for the concentration analysis by TOC were taken at 0 and 48 hours after start of exposure. The analytical results were in good agreement with the nominal concentrations. Statistical evaluation regarding the observations of immobilization was perfonned by pro bit analysis.

There was a clear concentration-effect relationship from 13.7 mg/L upwards at 24 and 48 hours. Thus, the immobilized Daphnia at 13.7 mg/L are assumed to be substance related, even if the accepted spontaneous immobilization rate of 10 % for the controls by the OECD guideline is considered. 100% of the Daphnia were immobilized at 22.5 mg/L ZK 155546 after 48 hours.

Description of key information

The ECso/48 hours ofZK 155546 to Daphnia magna was calculated to be 23.9 mg/L [95% confidence limits 11.6 - 49.1] on the basis of TOC
measured concentrations. The highest concentration without effects was 7.0 mg/L.
Accordingly, ZK 155546 is harmful to Daphnia magna, since the EC50 was between 10 and 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

23.9 mg/L