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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
long-term toxicity to fish, other
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
No details provided
Analytical monitoring:
yes
Details on sampling:
Frequency of analysis: 0th, 7th, 14th day
Vehicle:
not specified
Details on test solutions:
No data
Test organisms (species):
Oryzias latipes
Details on test organisms:
No data
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d
Post exposure observation period:
No data
Hardness:
Not specified
Test temperature:
24 +/- 1°C
pH:
Not specified
Dissolved oxygen:
Not specified
Salinity:
Not specified
Conductivity:
Not specified
Nominal and measured concentrations:
Nominal concentrations: 100, 50.0, 25.0, 12.5, 6.25 mg/L (geometric ratio: 2.0), control
Details on test conditions:
TEST SYSTEM
- Fill volume: 1.8 L
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1

TEST MEDIUM / WATER PARAMETERS: no data

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours dark

EFFECT PARAMETERS MEASURED: Mortality

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

RANGE-FINDING STUDY: not specified
Reference substance (positive control):
not specified
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
25 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Threshold level of lethal effect (14 d): 50.0 mg/L,
- Threshold level of observed effects (14 d): 50.0 mg/L,
- 50 % Lethal concentration (LC50) (7 d): > 100 mg/L,
Validity criteria fulfilled:
not specified
Conclusions:
Following a 14-d exposure period, the LC50 of Bis(2-chloroethyl) ether to Oryzias latipes was found to be > 100 mg/L. Based on mortality or other observed effects (not specified), the NOEC was 25 mg/L.
Executive summary:

This study was conducted on behalf of the Japanese Ministry of Environment (MOE). The methodology was based on OECD Technical Guideline N°204 under GLP. Nominal concentrations were 100, 50.0, 25.0, 12.5, 6.25 mg/L (geometric ratio: 2.0). One replicate was used per concentration with 10 fishes per test vessel. Following a 14-d exposure period, the LC50 of Bis(2-chloroethyl) ether to Oryzias latipes was found to be > 100 mg/L. Based on mortality or other observed effects (not specified), the NOEC was 25 mg/L. As no detailed information was available, a reliability factor of 2 was assigned to this guideline study.

Description of key information

The study selected as key information was conducted on behalf of the Japanese Ministry of Environment (MOE). The methodology was based on OECD Technical Guideline N°204 under GLP. Nominal concentrations were 100, 50.0, 25.0, 12.5, 6.25 mg/L (geometric ratio: 2.0). One replicate was used per concentration with 10 fishes per test vessel. Following a 14-d exposure period, the LC50 of Bis(2-chloroethyl) ether to Oryzias latipes was found to be > 100 mg/L. Based on mortality or other observed effects (not specified), the NOEC was 25 mg/L. As no detailed information was available, a reliability factor of 2 was assigned to this guideline study. Based on this result GHS-UN classification criteria are not met.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
25 mg/L

Additional information

Two bibliographic sources reported long-term toxicity data to fish.

The study selected as key information was conducted on behalf of the Japanese Ministry of Environment (MOE). The methodology was based on OECD Technical Guideline N°204 under GLP. While this guideline is no longer recommended to assess the long-term toxicity of chemicals to fish, this study was conducted before 2003 and is considered sufficienctly reliable for this assessment. Nominal concentrations were 100, 50.0, 25.0, 12.5, 6.25 mg/L (geometric ratio: 2.0). One replicate was used per concentration with 10 fishes per test vessel. Following a 14-d exposure period, the LC50 of Bis(2-chloroethyl) ether to Oryzias latipes was found to be > 100 mg/L. Based on mortality or other observed effects (not specified), the NOEC was 25 mg/L. As no detailed information was available, a reliability factor of 2 was assigned to this guideline study.

The only other available data on the long-term toxicity of Bis(2-chlorethyl) ether is provided within a report on chloroalkyl ethers published by the Office of Water Planning and Standards from the U.S. Environmental Protection Agency. Based on an embryo-larval test conducted on the fathead minnow (Pimephales promelas), the NOAEC of Bis(2-chloroethyl) ether was determined to be 19 mg/L. While U.S. EPA reports are subjected to a formal review, the minimal information provided in this report does not allow to fully judge the reliability of this data. Accordingly, this published NOAEC for the chemical safety assessment of Bis(2-chloroethyl) ether.

Conclusion: Based on available information the substance is not considered to exhibit significant long-term toxicity to fish.