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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From October 17, 2022 to November 14, 2022
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- The lowest and highest test item loading rates be analysed when freshly prepared and at the time of renewal on one occasion during the first week of the test (i.e. analyses should be made on a sample from the same solution - when freshly prepared and at renewal). These determinations were repeated at least at weekly intervals thereafter.
- Details on test solutions:
- Test solutions of required concentrations 3.2 and 10.2 mg/L were prepared by direct addition (by weighing) from the test item with the M4 medium. In order to facilitate the weight (viscous product), the test item was deposited on a glass slide and then, introduced into the glass flask for the mixing protocol.
The prepared samples were stirred 4 hours at 20 ± 2°C and at darkness. After a settling period of 15 minutes, the samples were sampled at the middle of the glass flask. The solutions obtained were named WAF (Water Accommodated Fraction).
It was not possible to prepare each WAF individually due to the limitations of weighing small amounts of UVCB and/or the large test solution volumes required.
According to Guidance document on aquatic toxicity testing of difficult substances and mixtures OECD n°23 [8], serial dilution of a single stock WAF may be the only practical approach; however, these reasons for this departure from standard practice were fully described in this test report.
Therefore, the concentrations 0.1 mg/L - 0.3 mg/L – 1.0 mg/L were prepared by dilution of the stock WAF solutions 3.2 or 10.2 mg/L. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: Daphnia magna Straus, clone number 5 at least the third generation (i.e. the third brood) obtained with a non-cyclic parthenogenesis reproduction.
- Age at study initiation (mean and range, SD): daphnids less than 24 hours old
- Length at study initiation (length definition, mean, range and SD): animals from a size between 560 µm and 800 µm
- Method of breeding: The daphnids breeding was carried out in closed bottles placed in a climatic chamber free from any toxic vapour and in medium M4.
- Feeding during test: It was done at least 3 times per week (i.e. corresponding to media changes). A ration of mixture of 2 algal cells (Chlorella vulgaris and Pseudokirchneriella subcapitata) between 0.1 and 0.2 mg
Carbon/Daphnia/Day is recommended. The ration was determined to obtain 60 offspring per parent animal in the controls. - Test type:
- semi-static
- Water media type:
- freshwater
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- The test was in semi-static conditions, all the medium were renewed every 48 hours.
The test duration was 21 days. - Hardness:
- 250-260 mg/L
Hardness was measured at least once a week, in fresh and old media, in the Control, the lowest and the highest test substance concentration. - Test temperature:
- 18-22°C (range ± 1°C)
An additional test vessel was used for the purpose of temperature monitoring. - pH:
- 7.7-8.8
pH values were measured at least once a week, in fresh and old media, in the Control, the lowest and the highest test substance concentration. - Nominal and measured concentrations:
- Five concentrations: 0.1 mg/L - 0.3 mg/L – 1.0 mg/L – 3.2 mg/L and 10.2 mg/L nominal test item loading rate /L, plus a Control (Test medium only) for the definitive test.
- Details on test conditions:
- Protocole
Protocol consisted of preparing a range of five test item concentrations in test medium M4 and a control, all in 10 replicates in glass flasks: one animal, young female daphnia aged less than 24 hours at the start of the test per flask (1 daphnia / flask).
The test was in semi-static conditions, all the medium were renewed every 48 hours.
The test duration was 21 days.
Test medium: M4 ELENDT - Dose descriptor:
- NOELR
- Effect conc.:
- 0.1 mg/L
- Conc. based on:
- test mat.
- Dose descriptor:
- LOELR
- Effect conc.:
- 0.3 mg/L
- Conc. based on:
- test mat.
- Dose descriptor:
- EL50
- Effect conc.:
- 2.2 mg/L
- Conc. based on:
- test mat.
- Details on results:
- The measured concentrations of the test item varied by more than ± 20 % of nominal or initial measured concentration during the test.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The coefficient of variation around the mean number of living offspring produced by parent animal in the controls was calculated. It is ≤ 25%, if the test was well run:
Coefficient of variation for control fecundity 13.1%
The results obtained show that test item “L-Leucine, reaction products with 1,4:3,6-dianhydro-D-glucitol, iso-Pr alc. and octanoyl chloride” has effect on the reproductive output of daphnids under the studied conditions and give an EL50 = 2.2 mg test item / L [1.6 - 3.5].
Results (in mg nominal test item loading rate) / L of test medium)
NOELR 0.1 mg/L
LOELR 0.3 mg/L
EL50 -21 days [Confidence interval 95%] 2.2 mg/L [ 1.6 – 3.5 ]
Validity criteria for OECD 211 were satisfied. - Executive summary:
The aim of this study was to assess the effects of the test item “L-Leucine, reaction products with 1,4:3,6-dianhydro-D-glucitol, iso-Pr alc. and octanoyl chloride” on the reproductive output of Daphnia magna, according to the OECD 211 guideline.
This study was carried out in accordance with the study plan no.21/1157F/d dated October 13, 2022.
There were three deviations (see § 9.3) and no amendment during this study.
At the end of the test, the total number of living offspring produced per animal alive at the end of the test was assessed.
The reproductive output of the animals exposed to the test item was compared to the control in order to determine the Lowest Observed Effect Loading rate (LOELR) and hence the No Observed Effect Loading rate (NOELR). In addition and as far as possible, the data were analysed using a regression model in order to estimate the concentration that would cause a X% reduction in reproductive output, i.e. ECx.
In agreement with the sponsor and according to the results of the study 21/1157F/c, the chemical analysis of “L-Leucine, reaction products with 1,4:3,6-dianhydro-D-glucitol, iso-Pr alc. and octanoyl chloride” in the test solutions was performed by GC/FID in order to check the test item stability throughout the study.
Results are presented as follows:
Number of living offsprings at 21 days in each flask
Nominal test item loading rates
Control
0.1 mg/L
0.3 mg/L
1.0 mg/L
3.2 mg/L
10.2 mg/L
Total of living offsprings
86
73
49
25
33
17
77
62
0
35
30
(43)
80
55
43
46
38
34
70
62
78
56
52
43
71
63
43
30
30
46
73
63
73
58
28
(48)
102
60
43
53
28
47
72
83
52
32
54
38
71
57
53
30
31
45
70
58
64
45
53
34
Mean of living offsprings
77.2
63.6
49.8
41
37.7
38.0
Total Aborted offsprings
0
0
0
19
45
51
Dead parent animal
/
/
/
/
/
2
The results obtained show that test item “L-Leucine, reaction products with 1,4:3,6-dianhydro-D-glucitol, iso-Pr alc. and octanoyl chloride” has effect on the reproductive output of daphnids under the studied conditions and give an EL50 = 2.2 mg test item / L [1.6 - 3.5].
Results (in mg nominal test item loading rate) / L of test medium)
NOELR
0.1 mg/L
LOELR
0.3 mg/L
EL 50 - 21 days
[Confidence interval 95%]
2.2 mg/L [ 1.6 – 3.5 ]
Validity criteria conformity:
Criteria
Validity for OECD 211
Validity for the test
Mortality of parent animals in the controls (female Daphnia) at the end of the test
≤ 20%
Ok (0%)
Mean number of live offspring produced per animal surviving in the controls
≥ 60
Ok (77.2)
All the validity criteria were successful.
Reference
Chemical analysis in daphnids solutions
The table below summarizes the results achieved and the variation between initial measurement and before renewal.
Control (mg/L) | 0.10 mg/L (nominal test item loading rate) | 10.2 mg/L (nominal test item loading rate) | ||
First week October 17 to 19, 2022 | At initial (Fresh) | <0.06 | 0.084 | 5.24 |
First week October 17 to 19, 2022 | Before renewal (Old) | <0.06 | <0.06 | 1.01 |
Variation (%) | - | - | >28.6 | -80.7 |
Second week October 25 to 27, 2022 | At initial (Fresh) | <0.06 | 0.073 | 6.70 |
Second week October 25 to 27, 2022 | Before renewal (Old) | <0.06 | <0.06 | <0.63 |
Variation (%) | - | - | >17.8 | > 90.6 |
Third week November 06 to 07, 2022 | At initial (Fresh) | <0.06 | 0.063 | 7.11 |
Third week November 06 to 07, 2022 | Before renewal (Old) | <0.06 | <0.06 | 0.63 |
Variation (%) | - | - | NA | -91.1 |
At the nominal concentration of 0.10 mg/L, the test item was not considered as stable in the testing conditions because the measured concentrations of the test item varied more than ± 20 % of initial measured concentration during the test.
At the nominal concentration of 10.2 mg/L, the test item was not considered as stable in the testing conditions because the measured concentrations of the test item varied more than ± 20 % of initial measured concentration during the test.
Description of key information
The results obtained show that test item “L-Leucine, reaction products with 1,4:3,6-dianhydro-D-glucitol, iso-Pr alc. and octanoyl chloride” has effect on the reproductive output of daphnids under the studied conditions and give an EL50 = 2.2 mg test item / L [1.6 - 3.5].
Due to the instability of the registered substance during the test system, we consider that the NOELR = 0.1 mg/L define the hazard of the degradation products and will not be used for the classification of the parent substance.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- 0.1 mg/L
Additional information
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