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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-12-13 to 2003-01-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD study, GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
479-540-8
EC Name:
-
Cas Number:
61007-89-4
Molecular formula:
C27 H27 Mn N4 O3
IUPAC Name:
manganese(3+) 2-[({2-[bis(2-{[(2-oxidophenyl)methylidene]amino}ethyl)amino]ethyl}imino)methyl]benzen-1-olate

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Samples were taken at the beginning and the end of each renewal period and analysed for transformation products.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: As the test item is prone to hydrolysis (please refer to section 5.1.2), the first stock solution was prepared as close as practically possible to the start of the test. This treatment fulfilled the recommandations of the OECD for poorly soluble substances subject to hydrolysis (OECD, 2000). To maintain the test concentrations constant during exposure, the test was performed under semi-static conditions. The stock solutions were renewed every 24 hours. Each stock solution was prepared as follows: 400 mg test item were weighed, dissolved in 4000 mL tap water. The stock solution was homogenised by ultrasonic treatement for about 10 minutes and then stirred for about 5 minutes. Due to the poor solubility of the test item, the not dissolved parts of the test item were separated by filtration (0.45 µm). The filtration was carried out under pressure with a flow rate not greater than 100 mL/min. The filter was preconditioned with 1000 mL of the stock solution. Afterwards, the rest of the stock solution was filtrated and the filtrate taken to prepare the test concentrations. Additonally, due to the light sensitivity of the test item, the glass vessel was covered with aluminium toil.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish {Danio rerio)
- Source: Zoo Tropic, Burgfelderstrasse 3, 4055 Basel, Switzerland
- Length at study initiation: (mean) 27 mm (range 25-29 mm) based on 7 fish of the control
- Weight at study initiation: (mean) 0.19 g (range 0.14-0.22 g) based on 7 fish of the control
- Feeding during test: Fish were not fed during the test period.
- Food type: commercially prepared zebrafish food diet: Mat Nr. 228221 DE, Tretra Werke 49304 Melle, Germany.

ACCLIMATION
- Acclimation period: at least 12 days
- Type and amount of food: commercially prepared zebrafish food diet: Mat Nr. 228221 DE, Tretra Werke 49304 Melle, Germany.
- Feeding frequency: Fish used in the test were not fed 48 hours prior to initiation of the test.
- Health during acclimation (any mortality observed):

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
142 mg CaCO3/L
Test temperature:
21.6 - 22.2°C
pH:
7.7 and 8.0
Dissolved oxygen:
95 - 98%
Nominal and measured concentrations:
100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 litre glass aquaria with a test volume of 3 litre
- Aeration: slightly aeration
- Renewal rate of test solution: 24 h renewal
- No. of organisms per vessel: 7 fish per concentration and control
- No. of vessels per concentration: Performed with one test chamber per concentration and control
- Biomass loading rate: 0.52 mg/L

TEST MEDIUM / WATER PARAMETERS
- in accordance to the guideline

OTHER TEST CONDITIONS
- Photoperiod: Fluorescent light, 16 hours daily with 30 min transition period

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: No sublethal effects such as changes in swimming behaviour, respiratory function, pigmentation or loss of equilibrium were observed in the control as well as in the treatment concentration of 100 mg/L during the 96-hour test period.
- Mortality of control: 1 fish
- Because the test item is prone to hydrolysis (please refer to section 5.1.2), no suitable method was avalaible to quantify the test item in water. Therefore, all biological results are related to the nominal concentrations of the test item.
Reported statistics and error estimates:
Due to the absence of mortality during the exposure, the median lethal concentration (LC50) was estimated without a statistical program.

Applicant's summary and conclusion