Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11-Nov. to 15 Nov 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study OECD 203, GLP, analytical monitoring.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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
Details on test material:
- Name of test material (as cited in study report): 1,6-Hexanedioldimethacrylate
- Substance type: organic
- Physical state at room temperature: liquid

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
Dilution water: purified drinking water

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Brachydanio rerio (Teleostei, Cyprinidae)
- Strain: Brachydanio rerio (Teleostei, Cyprinidae) (HAMILTON-BUCHANAN 1822)
- Source: West Aquarium GmbH, D-37431 Bad Lauterberg, Germany
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 2.6 ± 0.2 cm (min: 2.3 cm; max: 2.9 cm)
- Weight at study initiation (mean and range, SD): 0.13 g and 0.31 g with a mean weight: 0.22 ± 0.06 g
- Method of breeding: Laboratory bred
- Feeding during test: fish were not fed during the test (beginning 24 h prior to initiation)
- Food type: TetraMin® Hauptfutter
- Amount: no data
- Frequency: daily until 24 h before the test

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions (same as test or not): in dilution water of the same quality as used for the test
- Health during acclimation (any mortality observed): no data

Study design

Test type:
semi-static
Limit test:
no
Total exposure duration:
96 h

Test conditions

Test temperature:
varied between 22.0 ± 0.1 °C
pH:
varied between 8.03 and 8.78
Dissolved oxygen:
oxygen saturation in all test vessels was between 91.6% and 99.5%
Nominal and measured concentrations:
0.0, 1.1, 2.1, 3.7, 6.7 and 12.0 mg/L (nominal concentrations)
Details on test conditions:
Dilution water was prepared as follows. Purified drinking water was used as dilution water. The purification included filtration with charcoal, aeration and passage through a lime stone column. The water was aerated to oxygen saturation prior to preparation of the test solutions.

Test concentrations:
The pure test substance according to the chosen test concentration were pipetted in the test vessel and filled up with dilution water.

Test priciples and procedure:

10 fish were used for each test concentration including controls.
Only fish in good health and free from any apparent malformation were used.

15-l glass aquaria were used as test vessels and filled with 10 l of test solution. The test animals were added to the previously prepared test solution; controls were kept in dilution water (blank). Loading: 0.22 ± 0.06 g*LE-1

The aquaria were aerated via a glass capillary throughout the test.

The fish were exposed to various concentrations of the test substance for a period of 96 hours under semi static conditions. The test medium was changed completely every day. Mortalities and visual abnormalities were recorded at 24 h, 48 h, 72 h, and 96 h.

The test temperature was 22.0 ± 0.1 ° C. The pH of the dilution water was 0.03 to 8.78. The oxygen saturation in all test vessels was between 91.6 % and 99.5 %.
The light/dark rhythm was 14h/10h.

The pH, temperature and the oxygen concentrations of the control and of all the test concentrations were measured daily.

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 3.88 - 5.28 mg/L
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 3.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
6.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

 Cumulative Mortality of 1,6 -HDDMA on Brachydanio rerio (Zebra Fish)Total number of fish per concentration: n= m10.
                                                                                     Cumulative mortality of fish
 Nr   Test concentration (mg/l)  24h  48h  72h  96h
 0/0  blanc  0  0   0   0 
 1 1.1  0  0   0   0 
 2 2.1  0  0   0   0 
 3 3.7  0   0   0  0
 4 6.7 4 4  9   10 
 5 12.0 8  10   10   10 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
-Criteria of OECD 203: Mortality of controls <1
Conclusions:
In a valid guideline study (OECD 203, semi-static conditions), the 96 hr LC50 for Brachydanio rerio was 4.5 mg/L . Normal behaviour of the animals was observed during the whole test period.
Executive summary:

In a 96-h acute toxicity study, Brachydanio rerio were exposed to 1,6 -Hexanedioldimethacrylate

at 0 (control), 1.1, 2.1, 3.7, 6.7 and 12.0 mg/L nominal concentrations under semi-static conditions. The 96-h LC50was 4.5 mg a.i./L (95% confidence limt: 3.88 - 5.28 mg/L) based on mortality effects. The effect concentrations refer to the nominal concentrations. Based on the results of this study, 1,6 -Hexanedioldimethacrylate would be classified as toxic to Brachydanio rerio (Zebra fish) in accordance with the classification system of the EU. EU Category: chronic 2

 

This toxicity study is classified as acceptable and satisfies the guideline requirement for OECD 203, Brachydanio rerio (Zebra fish) toxicity study.

 

Results Synopsis

 

Test organism size/age: mean weight: 0.13 g and 0.31 g with a mean weight: 0.22 ± 0.06 g,

length: 2.6 ± 0.2 cm (min: 2.3 cm; max: 2.9 cm)

Test Type: semi-static

 

LC50: 4.5 mg a.i./L                         95% C.I.: 3.88 - 5.28 mg/L mg a.i./L                 

LC10:  3.71 mg a.i./L}                      

Endpoint(s) Effected: mortality

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.