Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: official guideline method, GLP with certificate, good documentation, identity of substance clear but no details on its purity

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
description: clear colourless liquid
batch number: 00925
storage conditions: room temperature, in the dark

Remark of the author of this IUCLID dossier concerning the substance identity:
Every page of the copy of the study report contains an annotation referring to the data sharing agreement in place between the licensee that uses this study report and the data owner. In this data sharing agreement the identity of the chemical substance is specified with "Ethyl Methyl Carbonate - EC No. 433-480-9, CAS Nr. 623-53-0".

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
For analytical monitoring, concentration of the substance in the test medium determined after 0 h, 24 h, 48 h, 72 h and 96 h. Determination of fresh media at 0 h and of old media at 96 h. At 24 h, 48 h and 72 h the old and fresh media were measured.

Duplicate samples taken. Stored frozen (- 20 °C) until analysed.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries Ltd, Hebden, near Skipton, Yorkshire, UK
- Received: 4 Dec 2000
- Keeping conditions until study: in-house, in a glass fibre tank with a "single-pass" water renewal system

ACCLIMATION
- Acclimation period: 31 Jan - 12 Feb 2001
- Acclimation conditions (same as test or not): yes
- Type of food/feeding: commercial trout pellets, feeding discontinued ca. 24 h before start of study
- Mortality: zero, 7 d prior to start of study
- Length at study end: mean standard length 5.0 cm (sd = 0.4)
- Weight at study end: mean weight 1.49 g (sd = 0.30)
- Loading rate (based on mean weight): 0.68 g bodyweight/litre

IN TEST:
- No individual identification of fish
- No feeding of fish
- Criteria of death: absence of both respiratory movement and response to physical stimulation

Study design

Test type:
other: semi-static: change of test solution at 0 h, 24 h, 48 h, 72 h and 96 h
Water media type:
freshwater
Total exposure duration:
96 h

Test conditions

Hardness:
ca. 100 mg/l CaCO3
Test temperature:
14 +/- 1 °C (temperature control and recorded at 0, 24, 48, 72, 96 h)
pH:
7.4 - 7.7 (recorded at 0, 24, 48, 72, 96 h)
Dissolved oxygen:
>= 9.0 mg O2/l () (recorded at 0, 24, 48, 72, 96 h)
Nominal and measured concentrations:
nominal: 100 mg/l
measured concentration range: 94 - 101 % of the nominal concentration
Details on test conditions:
TEST SYSTEM
- Test vessel: glas fibre tank with a "single pass" water renewal system. Minimal headspace. No auxiliary aeration during test. Covered and sealed.
- Test water: laboratory tap water dechlorinated (active carbon filter) and softened by addition of water softener (Elga Nimbus 1248D Duplex Water Softener)

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Remarks:
: 20 fish exposed, no mortalities
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Basis for effect:
other: sublethal effects and mortalities (none observed, 20 fish)
Details on results:
Range finding study, sub-lethal effects: none at all
Range finding study, mortality: none at all
Definitive study, sub-lethal effects: none at all
Definitive study, mortality: none at all

Any other information on results incl. tables

Test media: Clear, colourless solution throughout duration of the studies.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In the range-finding study as well as in the definitive study (20 fish) the LC50 was > 100 mg/L.
Based on these results no classification for acute aquatic toxicity is required according to REGULATION (EC) No 1272/2008 (of 16 Dec 2008).