Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
limit test
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Solutions were sampled through SPE cartridges slowly for approximately 45 minutes. After elution, the cartridges were dried using a vacuum pump. The test item was eluted from the SPE cartridges with dichloromethane.
Vehicle:
yes
Remarks:
acetone
Details on test solutions:
Test substance solutions were prepared in M7 medium
Nominal concentration of 1.3 µg/L was prepared by spiking 20µg/L of a stock solution of 65 mg/L (prepared in acetone) per liter of test solution. The final amount of acetone in solution was 20µg/L.
Solvent blanks were run in parallel during the experiment.
Test organisms (species):
Daphnia magna
Details on test organisms:
In-house laboratory culture with a known history.
Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
21 d
Hardness:
> 140 Mg/L as CaCO3 (161-214)
Test temperature:
18-22°C (18.8-19.8)
pH:
6.0 to 9.0, constant within 1.5 unit. (7.9-8.3)
Dissolved oxygen:
> 3 mg/L (4.7-9.4)
Salinity:
na
Conductivity:
na
Nominal and measured concentrations:
nominal 1.3 µg/L
measured: arithmetic mean (average) of geometric means of measurements in fresh and exhausted solutions along the experiment: 0.79 µg/L

Details on test conditions:
Test duration 21 days
Test type Semi-static
Frequency of renewal Every 48 hours
Test vessels Volume: 60 ml (6 x Ø 3.5 cm), all-glass covered with a Perspex plate.
Medium M7
Experimental design At the start of the experiment (nominal day 0) 20 neonate daphnids, less than one day old, per group were divided over twenty vessels each containing a minimum of 50 ml test medium.
Light 16 h photoperiod daily;
intensity at the start: 740-769 lux
intensity at the end: 737-760 lux
Feeding Twice daily an amount of 0.25 ml of a Chlorella sp. suspension . On weekend days an amount of 0.50 ml was added in one single feed. This daily ration corresponded to 0.2 mg C/Daphnia/day, which is the recommended value for daily feeding per daphnid in the reproduction test according to the OECD Guideline 211.
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Basis for effect:
reproduction
Remarks on result:
not determinable
Duration:
21 d
Dose descriptor:
NOEC
Basis for effect:
growth
Remarks on result:
not determinable
Details on results:
On average, 171 and 183 offspring were produced per surviving daphnid in the blank-control and solvent-control, respectively. In the limit concentration the total number of offspring was 178.
Statistical analyses showed a significant difference between the two controls and therefore the reproduction of the limit concentration was compared to the solvent-control group.
Reproduction:
Statistical analysis showed that the reproduction of the daphnids in the limit concentration was not statistically significantly reduced.
Occasionally, a few immobilised offspring or aborted eggs were observed in the three test groups. The numbers were not considered significant and were not test item related.
Body length:
The group mean body lengths of the surviving daphnids per concentration measured at the end of the test and the relative reduction of body lengths were compared to the control. Statistical analyses showed a significant difference between the two controls and therefore the mean daphnid length of the limit concentration was compared to the solvent-control group. Statistical analysis showed that the mean length of the daphnids in the limit concentration was not statistically significantly reduced.

Effect parameters, as reported:

Parameter

Average measured concentration (µg/L)

NOEC for reproduction

0.79

EC10forreproduction

> 0.79

EC50for reproduction

> 0.79

NOEC for mortality

0.79

NOEC for growth

0.79

Validity criteria fulfilled:
yes
Conclusions:
Limit test at concentration slightly above water solubility limit (on average 0.79 µg/L vs 0.26) did not show biologically relevant effects. No NOEC/LOEC can therefore be derived from the experiment. No EC10 can be derived either.
Executive summary:

A long-term toxicity test on freshwater invertebrate (Daphnia magna) according to OECD 211 was carried out on polysulfide, di-tet-dodecyl, on the request of ECHA. As the substance is very poorly soluble (OECD 105: WSL=0.26 µg/L) a limit test has been carried out at a concentration slightly above saturation (nominal: 1.3 µg/L, average measured: 0.79 µg/L). No biologically significant effect has been observed. Therefore, no full concentration/effect could be measured and no NOEC or EC10 can be derived and used for calculation of a PNECaqua.

No long-term toxicity of polysulfide, di-tet-dodecyl to reproduction of daphnids has been observed.

Description of key information

Chronic toxicity to Daphnia results are read across from polysulfides, di-tert-dodecyl.

No biologically significant effects were observed over the course of the study at the limit test concentration.

Key value for chemical safety assessment

Additional information

Chronic toxicity to Daphnia results are read across from polysulfides, di-tert-dodecyl. For further information please see the read across justification attached in the IUCLID robust study summary.

Migchielsen (2016) assessed chronic toxicity of polysulfide, di-tert-dodecyl in Daphnia magna. The study followed standard OECD guidelines (OECD 211) and used a single test concentration slightly above the saturation limit of the test item (nominally 1.3 µg/L), using acetone as a solvent. This equated to an average measured concentration of 0.79 µg/L in theDaphniastudy (measured using UPLC-MS/MS). Effects on reproduction were assessed over 21 days in a semi-static study. No biologically significant effects were observed over the course of the study at the limit test concentration.

The study followed standard guidelines and used test methods suitable for the poorly soluble test item, it is therefore considered to be reliable without restrictions.