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EC number: 401-280-0 | CAS number: 91273-04-0 CM 23-376; REOMET 30
- 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:
- key study
- Study period:
- 2013-01-07 to 2013-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
As the substance hydrolyses immediately in contact with water, data from the major constituent of the hydrolysate (bis(2 -ethylhexyl)amine is used to assess this endpoint. This constituent is also the most hazardous constituent to the aquatic environment. For further read across justification see IUCLID chapter 6.1 and CSR chapter 7.1.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Parent substance EC 401 -280 -0
The acute toxicity of the substance EC 401-280-0 to Daphnia was assessed according to OECD guideline no. 202 (1984). The respective EC50 24 h is 9.3 mg/L, based on nominal concentrations. As the exposure was only 24 hours, this data is only used as supportive information.
Furthermore, as the substance hydrolyses immediately in contact with water, data from the major constituent of the hydrolysate (bis(2 -ethylhexyl)amine is used to assess this endpoint. This constituent is also the most hazardous constituent to the aquatic environment. For further read across justification see IUCLID chapter 6.1 and CSR chapter 7.1.
Hydrolysis products
bis(2 -ethylhexyl)amine
The reported 48-h EC50 of bis(2-ethylhexyl)amine on Daphnia magna was 2.2 mg/L (nominal value) in a test using Tween 80 as a solvent. The EC50 was determined using non-neutralised samples (BASF AG 1/0500/2/89-0500/89, 1989).
Based on the results from a long-term reproduction study with Daphnia magna, the substance is classified as Chronic Category 1. Comparing the available aquatic toxicity data on the substance EC 401 -280 -0 with the data of bis(2 -ethylhexyl)amine shows that aquatic toxicity is in the same range. In most cases the derived effect concentrations of bis(ethyhexyl)amine are lower.Therefore, aquatic toxicity data of the major and the most hazardous component of the hydrolysate (bis(2-ethylhexyl)amine) is used as worst case to assess the acute toxicity to aquatic invertebrates of the substance EC 401-280-0 and its hydrolysate.
3. ANALOGUE APPROACH JUSTIFICATION
The aquatic toxicity data of the major and the most hazardous component of the hydrolysate (bis(2-ethylhexyl)amine) is used as worst case to assess the acute toxicity to aquatic invertebrates of the substance EC 401-280-0 and its hydrolysate. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.20 (Daphnia magna Reproduction Test)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ISO 10706
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all
- Sampling days: 0, 1, 2, 8, 9, 15, 16 - Details on test solutions:
- The stock solution (1 mg/L) was prepared by pipetting 2.8µL (2.27 mg based on the density, d=0.803 g/cm3) test substance into 2.27 L of test medium in a glass aspirator bottle (approx. 2 L) with a bottom side-outlet attached to a stopcock. The volume of test medium nearly filled the bottl leaving a small airspace so that the substance remained in contact with the test medium, but did not contact the bottle stopper. The bottle was immediately closed after adding the test substance and the solution gently stirred for approximately one day. The stirring was slow enough that no vortex formed on the surface at approx. 100 RPM. The bottle was inspected for the presence of undissolved substance on the solution surface. The stock solution was removed from the bottom of the bottle to separate it from any potentialundissolved portion remaining on the surface and visually inspected for the presence of any undissolved test substance. Once removed from the saturation bottle, the stock solution was handled in sealed vessels as far as possible to avoid atmospheric loss. The test solution for the control group was prepared in the same manner but without test substance.
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Source: Institut National de Recherche Chimique Appliquée (France, 1978), cultured continuously in BASF SE, Ecotoxicology Laboratory since 1978
- Age of parental stock (mean and range, SD): maximum 4 weeks
- Feeding during test: yes
- Food type: live green algae Desmodesmus subspicatus
- Amount: Day of test: 0-3 (0.10 mg TOC), 4-5 (0.12 mg TOC), 6-7 (0.14 mg TOC), 8-21 (0.20 mg TOC)
- Frequency: daily
ACCLIMATION
- Acclimation conditions (same as test or not): same as test - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Test temperature:
- 21 - 22°C
- pH:
- 7.5 - 8.6
- Dissolved oxygen:
- 6.7 - 9.3 mg/L
- Nominal and measured concentrations:
- Nominal: 0 (control), 0.018, 0.032, 0.056, 0.10, 0.18 mg/L
Measured (TWA):- Details on test conditions:
- TEST SYSTEM
- Test vessel: glass flask (50 mL nominal volume)
- Type (delete if not applicable): closed
- Aeration: none
- Material, size, headspace, fill volume: no headspace, fill volume approx. 50 mL
- Renewal rate of test solution (frequency/flow rate): 3 times per week
- No. of organisms per vessel: 1 parent
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
- Biomass loading rate: 0.02 animals/mL
OTHER TEST CONDITIONS
- Photoperiod: 16 light : 8 dark- Reference substance (positive control):
- yes
- Remarks:
- sodium chloride
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.069 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: per surviving parent as well as per introduced parent
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.133 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: per surviving parent as well as per introduced parent
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.039 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.069 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.069 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- other: days to first brood
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 0.133 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- other: days to first brood
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.269 mg/L
- Nominal / measured:
- meas. (TWA)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- All test solutions were visibly colorless and clear throughout each renewal period. No undissolved test substance or other unusual manifestations were observed.
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 48h EC50: 4.80 g/L (2012-12-12)Analytically measured concentration
Nominal concentration [mg/L]
Analytically measured concentration
Mean Initial
Mean 24 h old
Time-weighted mean
[mg/L]
[%]a
[mg/L]
[%]b
[mg/L]c
[%]a
0 (control)
n.d.
-
n.d.
-
n.d.
-
0.018
0.026
143
0.020
78
0.023
126
0.032
0.040
132
0.036
85
0.039
122
0.056
0.070
132
0.065
88
0.069
124
0.100
0.140
140
0.127
90
0.133
133
0.180
0.270
150
0.273
101
0.269
150
a % of nominal concentration
b % of mean initial
c based on 3 renewal period days
n.d. not detected
Reproduction and mortality after 21 d
Time-weighted mean concentration [mg/L]
Mortality (parent animals)
Reproduction per surviving parent
Reproduction per introduced parent
Mean living young
% effectb
Mean living young
% effectb
0 (control)
0
128
(10.5%a)
-
128
-
0.023
0
126
-
126
-
0.039
1c
113
-
113
-
0.069
2c
105
-
105
-
0.133
1c
82**
36**
82**
36**
0.269
3**
8**
94**
6**
95**
* p ≤ 0.05 ** p ≤ 0.01
a coefficient of variation for control fecundity based on surviving parent
b effect relative to control
c accidental or inadvertent death, replicates excluded in data evaluation
Other biological results
Time-weighted mean concentration [mg/L]
Growth (mean length in mm)
Mean % immobile young
Mean days to first brood
Mean % aborted eggs
0 (control)
4.4
0.4
8.5
0.5
0.023
4.3
0.4
8.7
0.8
0.039
4.2
0.2
8.6
0.9
0.069
4.1**
0.9
8.9
0.3
0.133
4.0**
4.0
11.2**
1.2
0.269
3.3**
-a
19.6**
-a
* p ≤ 0.05 ** p ≤ 0.01
a due to the low number of living young in test group 5, the number of aborted eggs and number of immobile young were set to missing and not included in the evaluation
Validity
In the control, mortality of parent animals up to the end of the test should be <= 20%.
In the control, the mean number of living young per parent animal that survived the test should be >= 60.
All validity criteria were met in this test.
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 21-d NOEC of Daphnia magna exposed to bis(2-ethylhexyl)amine was determined to be 0.069 mg/L.
Reference
Description of key information
The 21-d NOEC of Daphnia magna exposed to bis(2-ethylhexyl)amine was determined to be 0.069 mg/L. This result is used to assess the chronic toxicity of the substance EC 401-280-0 and its hydrolysate to aquatic invertebrates.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- 0.069 mg/L
Additional information
Parent substance EC401 -280 -0
No data on chronic toxicity to invertebrates are available. As the substance hydrolyses immediately in contact with water, data from the major constituent of the hydrolysate (bis(2 -ethylhexyl)amine is used to assess this endpoint. This constituent is also the most hazardous constituent to the aquatic environment. For further read across justification see IUCLID chapter 6.1 and CSR chapter 7.1.
Hydrolysis products
bis(2 -ethylhexyl)amine
In a long-term study with Daphnia magna according to OECD 211 with the major hydrolysis product bis(2-ethylhexyl)amine performed under GLP, the 21 -d NOEC (reproduction, growth) was determined to be 0.069 mg/L (TWA concentration).
1H-1,2,4 -triazole
No data on chronic toxicity to invertebrates are available. The substance is not acutely toxic to invertebrates.
The EC50 for fish is 97 mg/L. No toxicity to microorgamisms was observed. Based on the ErC50 72h algae is the most sensitive organism (ErC50 10-100mg/L), however the ErC10 72h algae is > 1mg/L. Chronic aquatic toxicity data are only available on fish (OECD 215) showing no effect on growth rate and mortility (NOEC 28d > 100mg/L) (ECHA disseminated REACH Dossier, 16 July 2014). Based on these data no chronic toxicity in Daphnia is expected. 1H-1,2,4-triazole is only a minor degradation product of EC 401-280-0.Thus, aquatic toxicity data on 1H-1,2,4-triazole are not regarded as relevant to evaluate the acute and chronic aquatic toxicity of the substance EC 401-280-0 and its hydrolysate.
Formaldehyde
No reliable data on long-term toxicity of formaldehyde on aquatic invertebrates are available.
As formaldehyde is readily biodegradable, data on chronic toxicity are not considered to be relevant to assess chronic toxicity of the substance EC 401-280- 0 and its hydrolysate.
Therefore, the test substance is considered as chronically toxic to aquatic invertebrates.
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