Trisodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]manganate(3-)

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2013-1-21 - 2013-1-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: A GLP study meeting all of the critical quality criteria. Analytical certificate present.Validated chemical analysis method used. Appropriate guideline followed. Considered valid without significant restrictions.

Justification for type of information:

The underlying hypothesis for the read-across is that chelates have the same mode of action based on their ability to chelate, remove or add metal cations to body causing perturbation of body’s micronutrients balance. The source substance (DTPA-FeHNa) and the target substance (DTPA-MnNa3) both have the same chelating agent – DTPA, the main difference is metal cation – Fe+3 and Mn+2 respectively.
More explanation can be found in Section 13 assessment Reports – “RA Statement” and “Justification of read-across within the aminocarboxylic acid (ethylenediamine-based) chelants chemical category - Environmental fate and ecotoxicology”.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)

EC Number:

235-627-0

EC Name:

Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)

Cas Number:

12389-75-2

Molecular formula:

C14-H18-Fe-N3-O10.H.Na

IUPAC Name:

Iron(3+) ion sodium 5-[bis(carboxylatomethyl)amino]-3-{[bis(carboxylatomethyl)amino]methoxy}pentanoate

Constituent 2

Reference substance name:

Diethylenetriaminepentaacetic acid, ferric sodium complex

IUPAC Name:

Diethylenetriaminepentaacetic acid, ferric sodium complex

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Product Name: Dissolvine : De-FE 11
Chemical Name: Diethylenetriaminepentaacetic acid, ferric sodium complex
Purity:97.2
Appearance: Yellow / Green Crystals
Cas Number: 12389-75-2
Project Number: T12050

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were taken of the only test concentration and the control solution at the start and at the end of the test as well as before and after solution refreshment.

Test solutions

Vehicle:

no

Details on test solutions:

The test chemical is soluble and prone to photo degradation. For this reason a semi static method with solution refreshment was chosen. A solution of approximately 100 mg/L was made by adding of an accurately weighed amount of the test substance to the test media and stirring until a homogenous solution was achieved. For both the first and the second stock solutions 0.5000 g of the test substance was weighed and dissolved in 5000 ml of test medium measured using a volumetric flask.

The pH of the first stock solution was 7.3 and this was adjusted to 8.1 with NaOH. The pH of the second stock solution was 6.9 and was adjusted to 8.2 with NaOH.

The stock solution was used directly in the test as the only test concentration. DSW was used directly in the control group.

The test medium was Dutch Standard Water (DSW), with a pH of approximately 8.2, and a conductivity between 550 and 650 µs/cm s-1, containing per
liter of de-ionized water: 200 mg of CaCl2•2H2O, 180 mg of MgSO4•7H2O, 100 mg of NaHCO3 and 20 mg of KHCO3. The guideline criteria requires the CaCO3 content to be between 10 and 250 mg/L. Hardness and conductivity in the test water was measured measured once at the start of the study as ºdH using the appropriate Dr Lange test kit and converted to the CaCO3 equivalent. Due to the total hardness kit measuring Calcium (as well as magnesium) the test kit was validated by analyzing a known CaCl2 Standard solution.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test was performed with juvenile Danio rerio (zebra fish) which, were accepted for use in testing according to laboratory standard operating procedures and as recommended in the corresponding OECD guideline . The batch was obtained from the “Dieren vriend” in Arnhem the Netherlands. The fish in stock were fed one to three times per day with commercially available dry, deep frozen food, or fresh Artemia salina nauplii /juvenile Daphnia magna neonates. Feeding was stopped 24 hours before the test was started, and the animals were not fed during the test. A representative number of test fish (10 at random) were weighed prior to the test and measured after the test to assess compliance with guideline criteria. The same number of
fish were measured at the end of the study for compliance with the length recommendations for this species.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Length of fish measured post exposure as well as a general physical examination.

Test conditions

Hardness:

233 mg/L as calcium carbonate

Test temperature:

22.2 to 22.9°C.

pH:

7.8 to 8.1

Dissolved oxygen:

7.7 to 9.0 mg/L

Salinity:

Not measured

Nominal and measured concentrations:

Nominal = 100 mg/L
Measured (lowest measured value)= 93.2 mg/L

Details on test conditions:

The test was performed as a semi static limit test which means that the test media was replaced after 48 hours to ensure test solution stability and
only a single test concentration was tested. The minimum requirement of 7 fish per test concentration and control were used for ethical reasons.

Under otherwise identical test conditions, the fish were exposed to the chosen concentration of the test substance as described below and mortality and sub-lethal effects were recorded at least at 30 minutes, 1, 2 and 4 hours after exposure and then and then at least 24, 48, 72 and 96 hours
with intermediate observations as often as possible. Particular attention was given to the test animals at the start of the test and directly after solution refreshment.

The fish were randomly placed in the test 3 liter glass test vessels / aquaria which were positioned in the test room in a random manner.
During the test the vessels were covered with glass plates. The test solutions present in the test vessels were aerated gently with water saturated air purified by an active coal filter and a cotton filter during testing.

Reference substance (positive control):

no

Remarks:

No longer permitted by Article 14 Animal testing expert.

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Measured Concentrations >80% (Nominal used)

Basis for effect:

mortality (fish)

Remarks on result:

other: N/A

Effect concentrations 2

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

other: Measured Concentration >80% (Nominal used)

Basis for effect:

behaviour

Remarks:

No behavioural effects observed

Remarks on result:

other: N/A

Details on results:

The results indicate no effects on mortality or behaviour at an analytically confirmed concentration of 100 mg/L.

Results with reference substance (positive control):

Not conducted

Reported statistics and error estimates:

N/A

Any other information on results incl. tables

Sublethal observations / clinical signs:

Chemical analysis results

Sample	Concentration (mg/L)
	0 h	48 h (old)	48 h (new)	96 h
Control	< LOQ	< LOQ	< LOQ	< LOQ
100 mg/L	104.1	93.2	104.2	95.6

Biological results

Conc. (mg/L)	No. of fish exposed	0 hours		30 minutes		1 hour		4 hours
		No. dead	Effects	No. dead	Effects	No. dead	Effects	No. dead	Effects
0 (Control)	7	-	7AN	-	7AN	-	7AN	-	7AN
100	7	-	7AN	-	7AN	-	7AN	-	7AN

 

Conc. (mg/L)	5.5 hours		20.5 hours		24 hours		29.5 hours
	No. dead	Effects	No. dead	Effects	No. dead	Effects	No. dead	Effects
0 (Control)	-	7AN	-	7AN	-	7AN	-	7AN
100	-	7AN	-	7AN	-	7AN	-	7AN

 

 

Conc. (mg/L)		45.5 hours		48 hours		53.25 hours		72 hours
		No. dead	Effects	No. dead	Effects	No. dead	Effects	No. dead	Effects
0 (Control)		-	7AN	-	7AN	-	7AN	-	7AN
100		-	7AN	-	7AN	-	7AN	-	7AN

 

 

Conc. (mg/L)		75.5 hours		80.5 hours		96 hours
		No. dead	Effects	No. dead	Effects	No. dead	Effects
0 (Control)		-	7AN	-	7AN	-	7AN
100		-	7AN	-	7AN	-	7AN

 AN=Appearing Normal

- = Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The test substance is considered as non toxic to Danio Rerio.