Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 25, 1992 - December 11, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
1)Salinity control
2)control
3)6.25 mg/L
4)25 mg/L
5)100 mg/L
In duplicate, at t= 0; t=48 hr (before renewal); t=48 hr (after renewal) and at t=96 hr
- Sample storage conditions before analysis:
Samples for the analysis of NBDA were stored below -20 degrees Celsius until analysis.
Vehicle:
no
Details on test solutions:
Preparation of the stock solution:
The stock solution was prepared twice during the test period. The amount of solid test chemical used was 2000 and 2002 mg on Sep. 27 and 29, 1992, respectively. The test chemical was added to 20 L reconstituted water. Before adding the test chemical, the pH of the water was adjusted to pH 2 by using HCL. The stock solution was stirred for 24 hours. During this period, NBDI dissociated completely. Before usage, the stock solution was adjusted to pH 7.8 with NaOH. The mean (nominal) concentration of the stock solution was 100.05 mg/L
Salinity control:
Reconstituted water adjusted to pH 2 with HCL and neutralised to pH 7.8 with NaOH
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Source: Forellenhof Fredelsloh, Mohringen, Germany
- Age at study initiation (mean): no data
- Length at study initiation (mean): 44.9 +/- 3.25 mm/fish
- Weight at study initiation (mean): 887.2 +/- 229.8 mg/fish
- Feeding during test: No

ACCLIMATION
- Acclimation period: 13 days
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not applicable
Hardness:
For all concentration levels and controls during the test period:
Min: 228 mg/L
Max: 267 mg/L
Mean: 240.29 mg/L
Test temperature:
For all concentration levels and controls during the test period:
Min: 14.8 degrees Celsius
Max: 15.5 degrees Celsius
Mean: 15.06 degrees Celsius
pH:
For all concentration levels and controls during the test period:
Min: 7.6
Max: 8.1
Mean: 7.81
Dissolved oxygen:
For all concentration levels and controls during the test period:
Min: 91%
Max: 96%
Mean: 93.57%
Salinity:
Not applicable
Nominal and measured concentrations:
Salinity control; Control; 6.25 mg/L; 12.5 mg/L; 25 mg/L; 50 mg/L and 100 mg/L
Mean measured concentrations at 6.25, 25 and 100 mg NBDI/L: 5.6, 20 and 82 mg NBDA/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Stainless steel vessels (16 L)
- fill volume: 10 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): batchwise after 48 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.887 g/L
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 82 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: NBDA
Details on results:
No mortalities occurred.
The analytically determined concentrations of NBDA are shown in the Table under "Any other information on results incl. tables"
Results with reference substance (positive control):
not applicable
Sublethal observations / clinical signs:

Table 1. Analytical results: measured concentrations of NBDA during the semi-static test

nominal (mg NBDI/L) measured concentration (mg NBDA/L)
0, fresh 48, old 48, fresh 96, old mean
6.25 5.59 4.28 5.50 6.46 5.6
5.49 5.66 5.77 5.98
25 19.7 19.7 20.5 22.2 20
14.9 14.4 22.0 23.2
100 73.3 75.0 85.9 91.1 82
82.2 77.3 79.7 90.3
Validity criteria fulfilled:
yes
Conclusions:
The 96h-LC50 in Oncorhynchus mykiss was determined to be >82 mg NBDA/L

Description of key information

The 96h-LC50 in Oncorhynchus mykiss was determined to be >82 mg NBDA/L

Key value for chemical safety assessment

Additional information

A study was conducted with NBDA: test solutions were prepared by adding NBDI to test medium, and allowing the substance to dissociate completely. No fish died at an analytically determined mean concentration of 82 mg NBDA/L.

Value used for CSA: LC50 for freshwater fish: >82 mg NBDA/L