Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Short-term toxicity to fish
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Remarks:
- the tested substance is the amine component of the compound
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restriction (e.g. non-GLP)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Di-isopropanolamine- Analytical purity: 99.3 %
Sampling and analysis
- Analytical monitoring:
- yes
Test solutions
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)- Method: The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria after 20 min.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM- Common name: Zebra fish- Age at study initiation (mean and range, SD): ca. 3.5 months- Length at study initiation (length definition, mean, range and SD): 3.29 cm (range: 2.8-3.6 cm)- Weight at study initiation (mean and range, SD): 0.305 g (range: 0.16-0.45 g- Method of breeding: - Feeding during test: 1 day before and during exposureACCLIMATION- Acclimation period:- Acclimation conditions (same as test or not): test conditions correspond to housing conditions- Type and amount of food:- Feeding frequency: - Health during acclimation (any mortality observed):QUARANTINE (wild caught)- Duration: - Health/mortality:
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
Test conditions
- Hardness:
- 2.5 mmol/l (ca. 250 mg/l CaCO3)
- Test temperature:
- 21-23 °C (average: 22.6 °C).
- Nominal and measured concentrations:
- Nominal test concentrations: 0 (control), 46.4, 100, 215, 464, 1000, 2150, and 10000 mg/l; additional test concentrations with pH adjustment: 1000 and 10000 mg/lConcentration control analysis (recovery: 95-106 %)
- Details on test conditions:
- TEST SYSTEM- Test vessel: : non-sealed all-glass aquaria (30x22x24 cm) - Fill volume: 10 l (water depth: ca. 17 cm) - Aeration: continuous and slight aeration with oil-free air - No. of organisms per vessel: 10- No. of vessels per concentration (replicates): 1- No. of vessels per control (replicates): 1- Biomass loading rate: 0.3 g fish / l test waterTEST MEDIUM / WATER PARAMETERS- Source/preparation of dilution water: municipal freshwater (Frankenthal, Germany), not chlorinated, passed through an active carbon filter. Total hardness: acid capacity: 5.5 mmol/l, Ca: ca. 90 mg/l, Mg: ca. 10 mg/l, pH ca. 8.0-8.6- Intervals of water quality measurement: temperature, pH, and oxygen content after 1, 24, 48, 72, and 96 hOTHER TEST CONDITIONS- Photoperiod: 16 h light and 8 h darknessEFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and symptoms after 1, 4, 24, 48, 72, and 96 h
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 464 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- 1 000 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 1 466 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: ; geometrical mean value
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- 2 150 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- White sediment was visible on the bottom of the aquaria.To study the effect of the relatively high pH on the toxicity, the concentrations 1000 and 10000 mg/l were tested in parallel after pH adjustment. At 1000 mg/l (nominal, neutralized) no dead fish where observed after 96 h while at 10000 mg/l (nominal; neutralized) all fish died.
- Reported statistics and error estimates:
- data evaluation: the number of dosis tested did not allow for a Probit analysis to be performed, since the data did not yield intermittent values between the LC0 (ca. 1000 mg/l) and the LC100 (ca. 2150 mg/l). Therefore the geoemtric mean of the two concentrations was calculated: LC50 (96 h): 1466 mg/l (nominal, based on measured data)
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Nominal concentration [mg/l]
Cumulative mortality (n)
1 h
4 h
24 h
48 h
72 h
96 h
Control
0
0
0
0
0
0
Control
0
0
0
0
0
0
46.4
0
0
0
0
0
0
100
0
0
0
0
0
0
215
0
0
0
0
0
0
464
0
0
0
0
0
0
1000x
0
0
0
0
0
0
1000x
0
0
0
0
0
0
2150
0
0
9
10
10
10
4640
6
10
10
10
10
10
10000
10
10
10
10
10
10
1000*
0
0
0
0
0
0
10000*
1
9
10
10
10
10
x: performed in duplicate
*: pH adjusted
Nominal concentration [mg/l]
Symptoms (n)
1 h
4 h
24 h
48 h
72 h
96 h
Control
-
-
-
-
-
-
Control
-
-
-
-
-
-
46.4
-
-
-
-
-
-
100
-
-
-
-
-
-
215
-
-
-
-
-
-
464
-
-
-
-
-
-
1000x
-
-
-
-
-
-
1000x
A
A
-
-
-
-
2150
A
AT
A
x
x
x
4640
AT
x
x
x
x
x
10000
x
x
x
x
x
x
1000*
-
-
-
-
-
-
10000*
A
A
x
x
x
x
Legend: A = apathy; T = tumbling
Nominal concentration [mg/l]
Oxygen concentration [mg/l]
1 h
4 h
24 h
48 h
72 h
96 h
Control
7.9
7.9
7.8
7.8
7.7
Control
8.1
7.9
7.3
7.4
7.7
46.4
8.1
7.9
7.9
8.2
7.6
100
8.1
8.0
7.9
8.2
7.8
215
8.0
7.9
7.7
8.1
7.7
464
8.1
7.9
7.7
8.2
7.7
1000x
8.1
8.2
8.1
8.4
8.0
1000x
7.9
8.0
7.5
7.4
8.0
2150
8.0
8.2
7.7
4640
8.1
10000
8.1
1000*
8.0
7.7
7.8
8.2
7.8
10000*
8.0
8.3
*: pH adjusted
Nominal concentration [mg/l]
pH
1 h
4 h
24 h
48 h
72 h
96 h
Control
8.4
8.3
8.3
8.4
8.4
Control
8.5
8.4
8.4
8.4
8.4
46.4
8.5
8.3
8.3
8.4
8.4
100
8.7
8.4
8.4
8.4
8.4
215
8.8
8.4
8.4
8.4
8.4
464
9.0
8.8
8.7
8.7
8.7
1000x
9.3
9.1
9.0
9.0
8.9
1000x
9.3
9.2
9.2
9.2
9.1
2150
9.5
9.5
9.4
4640
9.7
10000
10.0
1000*
8.6
8.4
8.3
8.4
10000*
8.7
8.7
Test item concentrations:
Nominal concentration [mg/l]
analytically detected concentrations
(% of nominal)1 h
96 h
Control
+
+
Control
46.4
99.1
105.6
100
98.0
101.0
215
95.3
98.1
464
95.9
98.5
1000x
95.6
98.2
1000x
2150
4640
10000
1000*
95.9
99.2
10000*
+: not detectable
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
