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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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23/01/2020-17/08/2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition 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
- Details on sampling:
- Chemical analysis of the fresh test preparations at 0 hours (see Annex 5) showed measured
concentrations of Isophoronediamine to range from 0.64 to 48 mg/L. Analysis of the
expired/old test preparations at 72 hour showed measured concentrations of
Isophoronediamine to range from 0.72 to 50 mg/L.
The dissolved test item may have been one or several components of the test item. Given that
toxicity cannot be attributed to a single component or 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 0-Hour measured concentrations of Isophoronediamine. - Vehicle:
- no
- Details on test solutions:
- Nominal amounts of test item (10, 32, 20, 64 and 200 mg) were each separately added to the
surface of 10, 10, 2.0, 2.0 and 2.0 liters of culture medium to give the 1.0, 3.2, 10, 32 and
100 mg/L loading rates respectively. After the addition of the test item, the culture medium
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. A 10 and 2.0 mL pipette, covered at one end with Nescofilm 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 Nescofilm was removed using the
2.0 ml pipette. The aqueous phase or WAF was removed by mid-depth siphoning (the first
75 to 100 mL discarded) to give the 1.0, 3.2, 10, 32 and 100 mg/L loading rate WAFs.
Microscopic inspection of the WAFs showed no micro-dispersions of test item to be present.
An aliquot (500 mL) of each of the loading rate WAFs was separately inoculated with algal
suspension (2.9 mL) to give an initial nominal cell density of 5.00 x 103 cells/mL.
The concentration and stability of the test item in the test preparations were verified by
chemical analysis at 0 and 72 hours (see Annex 5). - Test organisms (species):
- other: Raphidocelis subcapitata
- Details on test organisms:
- The test was carried out using Raphidocelis subcapitata strain CCAP 278/4. Liquid cultures
of Raphidocelis subcapitata were obtained from the Culture Collection of Algae and
Protozoa (CCAP), SAMS Research Services Ltd, Scottish Marine Institute, Oban, Argyll,
Scotland.
Approximately 3 to 4 days before the start of the test, inoculum cultures of algae was set up
at an initial cell density of approximately 103 cells/mL. The flasks were plugged with
polyurethane foam stoppers and kept under constant agitation by orbital shaker
(approximately 150 rpm) and constant illumination at 24 ±1 °C until the algal cell density
was approximately 105 to 106 cells/mL.
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 YY61NS) are given in Annex 2. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EL50
- Effect conc.:
- ca. 13 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- growth rate
- Validity criteria fulfilled:
- yes
- Conclusions:
- Exposure of Raphidocelis subcapitata based on nominal loading rates gave the following
results:
Response
Variable
EL50
(mg/L Loading
Rate WAF)
95% Confidence Limits
(mg/L Loading Rate
WAF)
No Observed
Effect Loading
Rate (NOEL)
(mg/L Loading
Rate WAF)
Lowest
Observed Effect
Loading Rate
(LOEL)
(mg/L Loading
Rate WAF)
Growth Rate 26 25 - 27 3.2 10
Yield 8.5 7.7 - 9.3 3.2 10
Exposure of Raphidocelis subcapitata based on 0-Hour measured concentrations of
Isophoronediamine gave the following results:
Response
Variable
EL50
(mg/L)
95% Confidence Limits
(mg/L)
No Observed
Effect Loading
Rate (NOEL)
(mg/L)
Lowest
Observed Effect
Loading Rate
(LOEL)
(mg/L)
Growth Rate 13 12 - 13 1.6 5.1
Yield 4.3 3.9 - 4.7 1.6 5.1 - Executive summary:
1.1 Introduction
A study was performed to assess the effect of the test item on the growth of the green alga
Raphidocelis subcapitata (formerly known as Pseudokirchneriella subcapitata). The method
followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals
(2006) No 201, "Freshwater Alga and Cyanobacteria, Growth Inhibition Test" and Method
C.3 of Commission Regulation (EC) 761/2009.
1.2 Methods
Due to the low aqueous solubility and complex nature of the test item for the purposes of the
study the test medium was prepared as a Water Accommodated Fraction (WAF) of the test
item.
Following a preliminary range-finding test, Raphidocelis subcapitata was exposed to Water
Accommodated Fractions (WAFs) of the test item over a range of nominal loading rates of
1.0, 3.2, 10, 32 and 100 mg/L (three replicate flasks per concentration) for 72 hours, under
constant illumination and shaking at a temperature of 24 ±1 °C.
Samples of the algal populations were removed daily and cell concentrations determined for
each control and treatment group, using a Coulter® Multisizer Particle Counter.
1.3 Results
Information provided by the Sponsor indicated that the test item degraded within 2 hours and
as a results 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 the 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 0.64 to 48 mg/L. Chemical analysis of
the aged to test preparations at 72 hours showed measured test concentrations of
Isophoronediamine to range from 0.72 to 50 mg/L.
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 Raphidocelis subcapitata based on nominal loading rates gave the following
results:
Response
Variable
EL50
(mg/L Loading
Rate WAF)
95% Confidence Limits
(mg/L Loading Rate
WAF)
No Observed
Effect Loading
Rate (NOEL)
(mg/L Loading
Rate WAF)
Lowest
Observed Effect
Loading Rate
(LOEL)
(mg/L Loading
Rate WAF)
Growth Rate 26 25 - 27 3.2 10
Yield 8.5 7.7 - 9.3 3.2 10
Exposure of Raphidocelis subcapitata based on 0-Hour measured concentrations of
Isophoronediamine gave the following results:
Response
Variable
EL50
(mg/L)
95% Confidence Limits
(mg/L)
No Observed
Effect Loading
Rate (NOEL)
(mg/L)
Lowest
Observed Effect
Loading Rate
(LOEL)
(mg/L)
Growth Rate 13 12 - 13 1.6 5.1
Yield 4.3 3.9 - 4.7 1.6 5.1
Reference
Description of key information
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 13 mg/L
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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