Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March 1 - 6, 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according the appropriate test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Concentration of TMPME - 99.0%.
Lot number - 3852802
Appearance - clear, colourless liquid
Density - 1010 kg/m3
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
TMPME is being used as a surrogate for TMPDE.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Portions of the test solution was sampled before the test and after 24 hours for analysis in the Sponsor's Laboratory. The analytical details and results have not been supplied.

Test solutions

Vehicle:
no
Details on test solutions:
24 hours prior to each exposure period 50 g of TMPME was dissolved in one litre of aerated dilution water and stirred for 24 hours. The water phase was used as the stock solution.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
No details have been reported. The fish species tested is not explicity stated but can be inferred from the statement that "the dilution water should allow survival of zebra fish for at least 96 hours".

Fish were placed in quarantine for 14 days prior to use in the study.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not applicable

Test conditions

Hardness:
Dilution water had a hardness in the range of 250 ± 25 mg calcium carbonate/L.
Test temperature:
The range over the course of the study was 23 ± 1°C
pH:
The range over the course of the study was 7.4 - 8.0
Dissolved oxygen:
The range over the course of the study was 73 - 100 % air saturation
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal exposure concentrations: 0 (xcontrol), 200, 400, 800, 1600 and 3200 mg/L
Details on test conditions:
No details
Reference substance (positive control):
yes
Remarks:
Disodium heptachromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
400 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Details on results:
Visible abnormalities (e.g. darker pigmentation, loss of equilibrium, disturbance in swimming behavior or increased respiration) were observed in all of the fish in the 800 mg/L treatment.
Results with reference substance (positive control):
The 24 hour LC50 of disodium heptachromate fulfilled the acceptance cirterion of 200 - 400 mg/L (S 028162).
Reported statistics and error estimates:
Not reported.

Any other information on results incl. tables

Fish mortality during the study is presented below:

Nominal exposure conc. (mg/L)

Cumulative mortality (seven fish per concentration)

 

% mortality at 96 hours

3 hours

24 hours

48 hours

72 hours

96 hours

Control

0

0

0

0

0

0

200

0

0

0

0

0

0

400

0

0

0

0

0

0

800

0

0

0

0

0

0

1600

6

7

7

7

7

100

3200

7

7

7

7

7

100

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Zebra fish were exposed to TMPME at nominal concentrations of 200, 400, 800, 1600 and 3200 mg/L in a semi-static 96 -hour acute toxicity test according to OECD 203 guidelines. The test design included an untreated control comprising of dilution water only. The 96-hour LC50 determined was 1200 mg TMPME/L (based nominal exposure concentrations). The NOEC (no-observed effect concentration) was 400 mg TMPME/L.
Executive summary:

Zebra fish were exposed to TMPME at nominal concentrations of 200, 400, 800, 1600 and 3200 mg/L in a semi-static 96 -hour acute toxicity test according to OECD 203 guidelines. The test design included an untreated control comprising of dilution water only. The 96-hour LC50 determined was 1200 mg TMPME/L (based nominal exposure concentrations). The NOEC (no-observed effect concentration) was 400 mg TMPME/L.