Reaction product of a ((2S)-2, 6-diaminohexanoic acid hydrochloride salt, phosphonic acid and methanal) with a 1,2-disubstituted alkane and sodium hydroxide.

Long-term toxicity to aquatic invertebrates

Administrative data

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to an appropriate national standard method but full details are not available. It was not conducted under GLP and no analytical monitoring was carried out.

Qualifier:

according to guideline

Guideline:

other: US EPA Methods for acute toxicity tests with fish, macroinvertebrates, and amphibians. EPA 66013-75-009. April 1975.

Deviations:

not specified

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

- Method: The test substance was diluted to make a stock solution of 100 mg/ml. In a 6 L flask well water and food was mixed. The solution was transferred into 1L volumetric flasks, mixed well, then 200 ml were drawn into the test vessels.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM

- Common name: water flea

- Feeding during test: The daphnids were fed at a concentration of 10 mg/l at each test medium renewal.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

28 d

Nominal and measured concentrations:

Nominal test concentrations: 3.37, 6.75, 12.5 and 25 mg active acid/L.

Details on test conditions:

TEST SYSTEM

- Test vessel:

- Material, size, headspace, fill volume: 250 ml test beakers filled with 200 ml test solution.

- Renewal rate of test solution (frequency): 2 day renewal

- No. of organisms per vessel: 5

- No. of vessels per concentration (replicates): 4

- No. of vessels per control (replicates): 4



TEST MEDIUM / WATER PARAMETERS

- Source of dilution water: Well water


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : survival and reproduction (offspring produced) at every water renewal (ca. 2 days).



RANGE-FINDING STUDY
A Range Finding study is said to have been conducted previous to the test in order to narrow down the range of concentrations in the test, however details were not reported. A short term acute test with Daphnia was also conducted which determined a 48 h EC50 equivalent to 883 mg active acid/L.

Reference substance (positive control):

no

Duration:

28 d

Dose descriptor:

NOEC

Effect conc.:

>= 25 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: adult survival and reproduction (no. of offspring)

Details on results:

- Mortality of parent animals: see Table 1 for details.

- Time to first brood release or time to hatch: the data reported shows that offspring were produced by day 9 in all treatment groups.

Reported statistics and error estimates:

For chronic data NOECs were determined by comparing means and standard errors in control vs. treated.

Table 1: Effect of ATMP on growth and survival of D. magna after 28 days (average of 4 replicates).

Nominal concentrations (mg a.a./L)	Mortality of parents		Cumulative number of offspring
	No. Alive	% mortality
Control	4.3 ± 1.2	14	143.7
25	4.0 ± 0.8	20	128.3
12.5	4.2 ± 1.5	16	139.5
6.75	4.2 ± 1.0	16	141.6
3.37	4.7 ± 0.5	6	155.4

 

Result expressed as nominal concentration. Properties of the test substance and evidence from other studies (where concentrations were 

measured) indicate that nominal and measured concentrations are likely to be in good agreement.

Not enough information is reported on water quality, however the frequency of water renewals suggests the parameters to be in acceptable ranges.

 

Validity criteria fulfilled:

not specified

Conclusions:

A 28 day NOEC value of >= 25 mg/L (as active acid) has been determined for the effects of the test substance on adult survival and reproduction of D. magna.

Description of key information

There are no studies available on SPE1415, however there is one reliable (Klimisch 2) long-term toxicity study with aquatic invertebrates conducted for the aminomethylphosphonate analogue substance, ATMP. In addition there is one reliable (Klimisch 2) study on another confidential analogue substance. These data are all included in this dossier. 

Using a conservative approach the most sensitive study result from across the analogue substances is identified and used to address the hazard endpoint in question.

One reliable (Klimisch 2) long-term toxicity study for ATMP with the freshwater crustacean Daphnia magna is available and follows published study guidelines (Monsanto Industrial Chemicals, 1976). The study was conducted over 28 days under static renewal conditions and the 28-day NOEC (adult survival and reproduction) was determined to be >=25 mg/L based on nominal test concentrations as ATMP active acid (22%).

The long term toxicity in aquatic invertebrates is considered to be >=25 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

25 mg/L