Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006/07/25-2007/01/24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted in compliance with the most recent edition of the OECD Principles of Good Laboratory Practice and with the principles of Good Laboratory Practice according to Annex 1 German Chemicals Act and the Principles of Good Laboratory Practice of the EU. The GLP standards applied include also the requirements of Japanese, US and other major non-European guidelines. The analytical practice was conducted in a GMP regulated laboratory.

Data source

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

Materials and methods

Test guideline
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:
Content: 99.0 %

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were taken at 0 (start) and 96 h (end) of the experiment

Test solutions

Details on test solutions:
The study was performed as a limit test, i.e. the concentration of the test item was 100 mg/L.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Species: Zebra fish (Danio rerio)
Breeder: known
Size: 2.0 +/- 1.0 cm

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
~15° dH
Test temperature:
Tempereature was between 25 to 26°C
pH:
pH values were within the range of 7.84 - 7.97
Dissolved oxygen:
Dissolved oxygen was within 74.8 - 96.4% oxygen saturation
Nominal and measured concentrations:
The DHA concentration in the test medium of nominal 100 mg/L was analyzed at the start and the end of the 96 hour exposure period. The mean analytical concentration was 102.6 and 95.9 mg/L at 0 and 96 hours, respectively and, thus, confirmed the correct preparation of the test medium.

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
and all other clinical findings
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
and all other clinical findings
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
and all other clinical findings

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
OECD 203 validity criteria fulfilled
Conclusions:
An aqueous solution of Dihydroxyacetone, of a nominal and analytical concentration of 100 mg/L, revealed no aquatic toxicity in the test system. The 96 hours LC50 to Danio rerio was > 100 mg/L (limit test) and, thus, could not be determined in this test.
Executive summary:

The objective of this study was to determine the acute toxicity to fish of the test material Dihydroxyacetone using zebra fish, Danio rerio. For this purpose, 10 fish in a test material group and further 10 fish in a control group were exposed over 96 hours, under defined conditions in a limit test. The fish were observed for signs of toxicity or death. Zebra fish were exposed to an aqueous test material solution of nominal 100 mg/L (limit-test) in an open static system.

Zebra fish exposed to an aqueous solution, with a nominal concentration of 100 mg Dihydroxyacetone per liter, were not affected. At the start, the analytically determined concentration was about 103 % of the nominal concentration. At the end of the experimental part, the analytically determined test material concentration was 96 % of the nominal concentration. Thus the test material concentration could be maintained at > 80 % of the initial concentration and the nominal value was regarded as equivalent to the analytical value. For the test material, Dihydroxyacetone, the following nominal and analytical LC50 values for zebra fish were determined:

24 h LC50 >100mg/L

48 h LC50 >100mg/L

72 h LC50 >100mg/L

96 h LC50 >100mg/L

An aqueous solution of Dihydroxyacetone at a concentration of 100 mg/L revealed no aquatic toxicity in the test system. The 96 hours LC50 to Dania rerio was > 100 mg/L (limit test) and, thus, could not be determined in this test.