Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Study period:
24 August 2007 - 25 September 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD Gudance Document 23 "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures" (September 2000)
Deviations:
no
GLP compliance:
yes
Remarks:
The study report includes a statement of GLP compliance signed by the study director and a statement of Quality Assurance, however no compiance certificate issued by an independant body (such as an official GLP monitoring authority) was provided.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): MMB-Ac (3-Methoxy-3-methylbutyl acetate).
- Physical state: Colourless liquid with ester-like odor.
- Analytical purity: 99.4%
- Impurities (identity and concentrations):3-methoxy-3-methylbutan-1-ol, 0.4%; 3-methoxy-1-methoxymethoxy)-3-methylbutane, 0.2%
- Lot/batch No.: 183227
- Stability under test conditions: Stable for more than one year at room temperature in an airtight stopper state.
- Storage condition of test material: Dark storage place at room temperature.

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
84.9 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: LC50 value estimated by the binomial test.
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
73.8 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: LC50 value estimated by the binomial test.
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
59.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
No behavioural anomalies seen at this level, either.
Details on results:
- Behavioural abnormalities: One surviving fish dosed at 76.9 mg/L was seen swimming at the surface, was found to have a comlpete loss of equilibrium, and reduced activity after 72 hours.
- Mortality of control: No mortality was seen in the control group.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour EC50 value in Medaka (Oryzias latipes) for the test item was determined to be 73.8 mg/L. The highest concentration showingno mortality after 96 hours was 59.2 mg/L.
Executive summary:

An acute fish toxicity test was conducted to assess the effect of the test material on fish. The study was conducted according to OECD test guideline 203 and in compliance with GLP.

Test groups of eight Medaka (Oryzias latipes) per group were exposed to test medium containing the test material at concentrations 0 (control), 35.0, 45.5, 59.2, 76.9, and 100 mg/L. The test was conducted over 96 hours, and the test medium was replaced at 24 -hour intervals. The fish were observed for mortality and abnormal behavious at 3 hours from the start of the exposure period, and then at 24, 48, 72, and 96 hours from the start of exposure.

Mortalities were seen in the 76.9 and 100 mg/L dose levels; all fish at the 100 mg/mL level had died by the 48 -hour timepoint.

The 96-hour EC50 value in Medaka (Oryzias latipes) for the test item was determined to be 73.8 mg/L. The highest concentration showingno mortality after 96 hours was 59.2 mg/L.