1,3-dimethyl-1,3-diphenylurea

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

9.7.-13.7.1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable guideline study, tested with the source substance Ethyl centralite. According to the ECHA guidance “Practical guide 6" the reliability was changed to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
See attached document in IUCLID Section 13 - RA Justification document.pdf

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See attached document in IUCLID Section 13 - RA Justification document.pdf

3. ANALOGUE APPROACH JUSTIFICATION
See attached document in IUCLID Section 13 - RA Justification document.pdf

4. DATA MATRIX
See attached document in IUCLID Section 13 - RA Justification document.pdf, Table 1: Data matrix

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

other: "Letale Wirkung beim Zebrabärbling-Brachydanio rerio-" (LC 0, LC 50, LC 100; 48-96 Stunden) Verfahrensvorschlag: Umweltbundesamt Berlin, Stand Mai 1984

Deviations:

yes

Remarks:

Sehen "Overall remarks"

Principles of method if other than guideline:

Bei definierten Konzentrationen einer Prüfsubstanz ergeben sich nach Ablauf der Prüfzeit jeweils bestimmte prozentuale Anteile toter Fische. Die LC 0 und LC 100-Werte werden dabei aus der Prüfung direkt bestimmt, während der LC 50-Wert rechnerisch oder graphisch aus der Dosis-Wirkungs-Kurve ermittelt wird. Die Prüfdauer beträgt 96 Stunden.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- täglich Überprüfung der Konzentrationen: 7.8, 11, 16, 22, 31, 44 mg/L sowie einer Kontrolle

Details on test solutions:

VERDÜNNUNGSWASSER: synthetisches Süsswasser nach ISO
LÖSUNGVERMITTLER ODER ANDERE HILFSMITTEL: Ultra-Turrax

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrabärbling (Brachydanio rerio)
- Strain: HAMILTON BUCHANAN
- Source: West-Aquarium (Bad Lauterberg)
- Age at study initiation (mean and range, SD): cca 4 months
- Length at study initiation (length definition, mean, range and SD): 2.5 - 3.5 cm
- Health during acclimation (any mortality observed): keine Hälterungsmortalität, keine Medizinische Vorbehandlung

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

20.7 - 21.6°C

pH:

7.4 - 8.1

Dissolved oxygen:

7.1 - 8.7 mg/L

Nominal and measured concentrations:

7.8, 11, 16, 22, 31, 44 mg/L (Nominalkonzentration)

Details on test conditions:

TEST SYSTEM
- Test vessel: Testaquarien 300x135x200 mm (8.1 L)
- Test medium: 5 L
- Aeration: belüftet
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : alle 24 Stunden (0, 24, 48 and 96 Stunden) - Abiotische Parameter (Temperatur, Sauerstoff, pH-Wert) and Mortalität

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

11 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

22 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.:

15.6 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Geometr. Mittel LC 0/ LC 100

Sublethal observations / clinical signs:

Die in Wasser eingewogene Substanz wurde zur Herstellung der entsprechenden Testansätze 60 Sekunden mit dem Ultra-Turrax behandelt. Bei allen Konzentrationen verblieben ungelöste Stoffanteile in Pulverform an der Oberfläche des Testmediums.

Description of key information

The read-across substance Ethyl centralite was tested in acute toxicity test on Brachydanio rerio. The test duration was 96 hours. The LC 0 and LC 100 values were determined directly. The LC 50 value was determined by calculation as the geometric mean of LC0/LC100.

LC50 = 15.6 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

15.6 mg/L