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EC number: 266-267-2 | CAS number: 66230-21-5
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/01/2020-17/09/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Information as provided by the Sponsor. A Certificate of Analysis supplied by the Sponsor is
given in Annex 1.
Identification: CAS 71077-09-3
Batch: 12846
CAS Number: 71077-09-3
Purity: 97.32%
Physical State/Appearance: Pale yellow viscous liquid
Expiry Date: 30 November 2020
Storage Conditions: Room temperature in the dark, under nitrogen - Analytical monitoring:
- not specified
- Vehicle:
- no
- Details on test solutions:
- Based on the results of the range-finding test the following loading rates were assigned to the
definitive test: 10, 18, 32, 56 and 100 mg/L.
Nominal amounts of test item (20, 36, 64, 112 and 200 mg) were each separately added to the
surface of 2.0 liters of test water to give the 10, 18, 32 ,56 and 100 mg/L loading rates
respectively. After the addition of the test item, the test water was stirred by magnetic stirrer
using a stirring rate such that a vortex was formed to give a dimple at the water surface. The
stirring was stopped after 23 hours and the mixtures allowed to stand for 1 hour. Visual
observations made on the WAFs indicated that a significant amount of dispersed test item
was present in the water column and hence it was considered justifiable to remove the WAFs
by filtering through a glass wool plug to remove the undissolved test item from the test
solutions. A 10 and 2.0 mL pipette, covered at one end with Parafilm was submerged into the
vessels, sealed end down to mid-depth within the vessels. A length of Tygon tubing was
attached to the 10 mL pipette and the Parafilm was removed using the 2.0 ml pipette. A glass
wool plug was inserted into the opposite end of the tubing and the WAF removed by
mid-depth siphoning (the first 75 to 100 mL discarded) to give the 10, 18, 32, 56 and
100 mg/L loading rate WAFs. Microscopic observations of the WAFs were performed after
filtering and showed no micro-dispersions of test item to be present.
The concentration and stability of the test item in the test preparations were verified by
chemical analysis at 0 and 48 hours (see Annex 5). - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- The test was carried out using first instar Daphnia magna derived from in-house laboratory
cultures.
Adult daphnids were maintained in 150 mL glass vessels containing 100 mL Elendt M4
medium (see Annex 2) in a temperature controlled room maintaining the water temperature at
18 to 22 °C. The lighting cycle was controlled to give a 16 hours light and 8 hours darkness
cycle with 20 minute dawn and dusk transition periods. Each culture was fed daily with a
mixture of algal suspension (Raphidocelis subcapitata) and GEMMA Micro 300 fish food
suspension. Culture conditions ensured that reproduction was by parthenogenesis. Gravid
adults were isolated the day before initiation of the test, such that the young daphnids
produced overnight were less than 24 hours old. These young were removed from the
cultures and used for testing. The diet and diluent water are considered not to contain any
contaminant that would affect the integrity or outcome of the study.
A positive control test using potassium dichromate as the reference item was performed twice
in a 12 month period to demonstrate satisfactory conditions of the test. Details of the most
recent positive control (Covance study number GV41TT) are given in Annex 3. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Reference substance (positive control):
- not specified
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- ca. 20 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- 6.1 Range-finding Test
Cumulative immobilization data and other observations from the exposure of Daphnia magna
to the test item during the range-finding test are given in Table 1.
No sub-lethal effects of exposure were observed throughout the test.
No immobilization was observed at 1.0 and 10 mg/L loading rate WAF, however,
immobilization was observed at 100 mg/L loading rate WAF.
Based on this information loading rates of 10, 18, 32, 56 and 100 mg/L were selected for the
definitive test.
Information provided by the Sponsor indicated that the test item degrades after approximately
2 hours and therefore the chemical analysis was based on one of the degradant products that
were determined.
Chemical analysis of the test preparations at 0 hours (see Annex 5) showed measured test
concentrations of Isophoronediamine to range from 0.61 to 50 mg/L. There was no
significant change in the measured concentrations at 48 hours indicating that the degradant
product being measured was stable under test conditions.
Cumulative immobilization data and other observations from the exposure of Daphnia magna
to the test item during the definitive test are given in Table 2. The relationship between
percentage immobilization and concentration at 48 hours for nominal loading rates is given in
Figure 1. The relationship between percentage immobilization and concentration at 48 hours
for 0-Hour measured test concentrations is given in Figure 2.
Analysis of the immobilization data by Weibull analysis using Linear Maximum-Likelihood
regression method at 24 and 48 hours based on the nominal loading rates gave the following
results:
Time
(Hour)
EL50
(mg/L Loading Rate)
95% Confidence limits
(mg/L Loading Rate WAF)
24 98 22 - 442
48 46 18 - 118
The NOEL rates after 24 and 48 hours exposure were 56 and 32 mg/L loading rate WAFs
respectively. Correspondingly the LOEL rates were considered to be 100 and 56 mg/L
loading rate WAFs.
The slopes and their standard errors of the response curves at 24 and 48 hours were 6.8
(standard error = 0.052) and 10 (standard error = 0.024) respectively.
Analysis of the immobilization data by Weibull analysis using Linear Maximum-Likelihood
regression method at 24 and 48 hours based on the 0-Hour measured test concentrations gave
the following results:
Time
(Hour)
EL50
(mg/L)
95% Confidence limits
(mg/L)
24 43 9.7 - 190
48 20 7.3 - 55
The NOEL rates after 24 and 48 hours exposure were 24 and 13 mg/L loading rate WAFs
respectively. Correspondingly the LOEL rates were considered to be 44 and 24 mg/L loading
rate WAFs.
The slopes and their standard errors of the response curves at 24 and 48 hours were 6.9
(standard error = 0.050) and 11 (standard error = 0.023) respectively.
Sub-lethal effects of exposure were observed in 18, 56 and 100 mg/L loading rate test groups.
These responses were reduced mobility (see Table 2). - Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of Daphnia magna based on nominal loading rates gave the following results:
Time Point
(Hours)
EL50
(mg/L Loading
Rate WAF)
95% Confidence Limits
(mg/L Loading Rate
WAF)
NOEL
(mg/L Loading
rate WAF)
LOEL
(mg/L Loading
Rate WAF)
48 46 18 - 118 32 56
Exposure of Daphnia magna based on 0-Hour measured concentrations gave the following
results:
Time Point
(Hours)
EL50
(mg/L)
95% Confidence Limits
(mg/L)
NOEL
(mg/L)
LOEL
(mg/L)
48 20 7.3 - 55 13 24 - Executive summary:
1 SUMMARY
1.1 Introduction
A study was performed to assess the acute toxicity of the test item to Daphnia magna. The
method followed was designed to be compatible with the OECD Guidelines for Testing of
Chemicals (April 2004) No 202, "Daphnia sp., Acute Immobilisation Test" referenced as
Method C.2 of Commission Regulation (EC) No. 440/2008.
1.2 Methods
Due to the low aqueous solubility and complex nature of the test item, for the purposes of the
test, the test medium was prepared as a Water Accommodated Fraction (WAF).
Following a preliminary range-finding test, 20 daphnids (4 replicates of 5 animals) were
exposed to Water Accommodated Fractions (WAFs) of the test item over a range of nominal
loading rates of 10, 18, 32, 56 and 100 mg/L for 48 hours at a temperature of 21 °C to 22 °C
under static test conditions. The number of immobilized Daphnia and any adverse reactions
to exposure were recorded after 24 and 48 hours.
1.3 Results
Information provided by the Sponsor indicated that the test item degraded within 2 hours and
as a result of the method of preparation for the test samples, chemical analysis was performed
on a degradant product instead of the parent material. The chemical analysis was performed
on Isophoronediamine, one of identified degradant products of the parent material.
Chemical analysis of the fresh test preparations at 0 hours showed measured test
concentrations of Isophoronediamine to range from 4.5 to 44 mg/L. Chemical analysis of the
aged test preparations at 48 hours showed measured test concentrations of Isophoronediamine
to range from 4.6 to 43 mg/L.
The dissolved test item may have been one or several components of the test item. Given that
the toxicity cannot be attributed to a single component or a mixture of components, but to the
test item as a whole, the results were based on nominal loading rates and at the request of the
Sponsor results were also based on the 0-Hour measured concentrations of
Isophoronediamine.
Exposure of Daphnia magna based on nominal loading rates gave the following results:
Time Point
(Hours)
EL50
(mg/L Loading
Rate WAF)
95% Confidence Limits
(mg/L Loading Rate
WAF)
NOEL
(mg/L Loading
Rate WAF)
LOEL
(mg/L Loading
Rate WAF)
48 46 18 - 118 32 56
Exposure of Daphnia magna based on 0-Hour measured concentrations gave the following
results:
Time Point
(Hours)
EL50
(mg/L)
95% Confidence Limits
(mg/L)
NOEL
(mg/L)
LOEL
(mg/L)
48 20 7.3 - 55 13 24
NOEL =
Reference
Description of key information
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 20 mg/L
Additional information
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