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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22/02/2001 - 06/12/2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Sampling days: 0, 6, 13, 20, 27, 31, 35, 41, 48, 52, 55, 62, 69, 76, 84, and 94
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Species/strain: Rainbow trout (Oncorhynchus mykiss)
Source: Forellenhof Oristal, CH4410 Liestal, Switzerland
Wild caught: No
Age/size: Newly fertilised eggs
Kind of food: Hokovit 500 and Hokovit 502 (H.U. Hofmann AG, CH-4922 Bützberg, Switzerland)
Amount of food: Fish were fed ad libitum
Feeding frequency: Twice a day
Post-hatch transfer time: Not applicable
Time to first feeding: Before total consumption of the yolk sack
Feeding of animals during test: Yes
Treatment for disease within 2 weeks preceding test: n.a.
Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
94 d
Post exposure observation period:
None
Hardness:
198 – 342 mg/L as CaCO3
Test temperature:
9.9 - 12.9 ºC
pH:
7.0 - 7.8
Dissolved oxygen:
8.1 - 10 mg-L
Salinity:
Not applicable
Nominal and measured concentrations:
See table below
Details on test conditions:
Intensity of irradiation: study start – one week after hatching: in the dark; one week after hatch – end of exposure: 340 – 470 Lux.
Photoperiod: 16 hour light / 8 hour dark with a 30 min transition period each
Reference substance (positive control):
no
Duration:
94 d
Dose descriptor:
NOEC
Effect conc.:
6.4 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
growth and survival
Details on results:
See table below.
Results with reference substance (positive control):
Not applicable

Effect

Control

10mg/L (Test concentration)

NOEC

Fertilisation rate [%]

93 – 100 %

n.d.

n.a.

Start hatch [d]

31

31

n.a.

End hatch [d]

34

34

n.a.

Hatching rate [%]

92

97

≥ 10 mg/L

Development rate [1/d]

0.031

0.031

≥ 10 mg/L

Swim up [%]

98

97

≥ 10 mg/L

Mortality [n]

1

2

≥ 10 mg/L

Visible abnormalities[n]

0

0

≥ 10 mg/L

Length[mm]

41.0 ± 5.3

41.9 ± 4.5

≥ 10 mg/L

Dry weight[g]

0.15 ± 0.05

0.16 ± 0.06

≥ 10 mg/L

Validity criteria fulfilled:
yes
Conclusions:
The test item concentration on the sampling days 48, 69, 64 and 65 ranged from 64-75 % and ranged from 109 to 129 % of the nominal concentration at any other sampling day, resulting in an overall mean measured test concentration of 104 %. There was no indication for malfunction of the dosing system, the water flow or the consumption of the application solution.

Since no adverse effects were observed throughout the course of the study, using the lowest measured test item concentration would be a worst-case scenario still leading to a robust endpoint. Therefore the author of this summary recommends to use an overall NOEC of 6.4 mg/L rather than the reported overall NOEC of 10 mg/L.

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
10.1 mg/L

Additional information