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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
fish, juvenile growth test
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 2000 to March 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD, EPA, etc)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 215 (Fish, Juvenile Growth Test)
Deviations:
yes
Remarks:
It is not likely that any of the deviations influenced the results of the test.
Principles of method if other than guideline:
Deviations from the OECD guideline:
* The average weight of the fish used in the test was 0.03 g; instead of 0.05 g as recommended in the OECO guideline.
* The weight of the fish was detennined as total wet weight per test vessel at the start and at the end of the test.
* The temperature in the clean and spent exposure media were measured at replacement and not daily.
* The specific growth rate was not detennined, but statistical significance for growth was tested.
There were no further deviations from the protocol.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Bromoacetic acid
EC Number:
201-175-8
EC Name:
Bromoacetic acid
Cas Number:
79-08-3
Molecular formula:
C2H3BrO2
IUPAC Name:
2-bromoacetic acid
Test material form:
other: light brownish liquid
Details on test material:
- Name of test material (as cited in study report): monobromoacetic acid (80% solution in water)
- Substance type: light brownish liquid
- Composition of test material, percentage of components: 80% solution in water
- Lot/batch No.: 00-2391
- Expiration date of the lot/batch: 11 August 2001
- Storage condition of test material: room temperature - not protected from the light
- Other:
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
refer to the section 4: Physical and chemical properties

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: Aliquots of ca. 10 ml were sampled in glass scintillation flasks from the newly prepared control (sample from two test beakers) and from the 100 mg/L solution (duplicate samples from each test beaker) at t = 3, 10, 17 and 24 days. The same (spent) media were sampled again at t = 5, 12, 19 and 26 days.

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: This medium is prepared by the addition of several salts to ground water from a locality near Linschoten (the Netherlands). The ground water contains several other trace elements (<1mg/L).
-Profile of the medium:
The medium is prepared in large amounts (10.000 L) and the following components of the batch used for this test were checked by chemical analysis and
found to be:
* Na+ 1.37 mmol/L
* K+ 0.21 mmol/L
* Ca2+ 1.53 mmol/L
* Mg2+ 0.85 mmol/L
* Cl- 2.82 mmol/L
* SO4^2- 0.66 mmol/L

Some traces of minerals were added (as salts) to the batch used together with some EDT A, resulting in the following final element and EDT A concentrations.
* B 46.25 µmol/L
* Mn 1.82 µmol/L
* Li 7.22 µmol/L
* Rb 0.59 µmol/L
* Sr 0.57 µmol/L
* Br 0.16 µmol/L
* Mo 0.26 µmol/L
* Cu 0.10 µmol/L
* Zn 0.10 µmol/L
* Co 0.04 µmol/L
* I 0.02 µmol/L
* Se 0.01 µmol/L
* V 0.05 µmol/L
* Fe 0.36 µmol/L
* Na2EDTA 0.67 µmol/L

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Brachydanio rerio
- Source: commercial hatchery Atlanta, Hellevoetsluis. the Netherlands
- Weight at study initiation (mean and range, SD): 0.03 +/- 0.007 g ((measured on 16 fish of the batch)

FEEDING DURING TEST
- Food type: Artemia larvae
- Amount: Not reported
- Frequency: Not reported

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
28 d

Test conditions

Hardness:
CaCO3 = 238 mg/L
Total organic carbon content is 1.2 mg/L
Test temperature:
24 +/- 1°C
pH:
7.0-8.3
Dissolved oxygen:
Lowest value: 7.0 mg O2/L
Nominal and measured concentrations:
100 mg/L of monobromoacetic acid 80% in solution
Details on test conditions:
TEST SYSTEM
- Test vessel: The test was performed in 2 litre all-glass beakers, each containing 1.5 litre of exposure medium; the beakers were covered with a watch glass.
- Type (delete if not applicable): closed
- Aeration: slightly aerated
- Renewal rate of test solution (frequency/flow rate): The exposure media were replaced on Monday, Wednesday and Friday.
- No. of organisms per vessel: 16 fish
- No. of vessels per concentration (replicates): 2 replicates per test concentration
- No. of organisms per control vessel: 16 fish
- No. of vessels per concentration (replicates) for the control: 4 replicates per control

TEST MEDIUM / WATER PARAMETERS
Refer to the "details on test solution" for details

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The test vessels were daily checked for mortality dead and the living animals were counted. At the same time the condition (swimming behaviour, colour or any other visually observable morphological or behavioural criterion) of the survivors was compared with that of the control animals.

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: preliminary range-finding test indicated that no adverse effects were to be expected at 100 mg/L, therefore only one concentration of monobromoacetic acid was tested in a limit test.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
growth rate
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Condition: (swimming behaviour, colour or any other visually observable morphological or behavioural criterion)
Details on results:
There was no mortality in the control medium at the end of the test. At 100 mg/L, one animal died at t = 5 days, but because 10% mortality (in the control) is allowed according to OECD 215, this mortality is not considered as an adverse effect with regard to mortality as criterion.

- ANALYTIC:
The measured concentrations in the clean solutions confirm the correct dosing of the test substance.
During the test the actual concentration in the spent solutions decreased gradually; from 86% at t = 5 days to 37% at t = 26 days.
During the test the average percentage in the clean and spent solutions were 96% and 58 % respectively. According to the specific analysis breakdown products were not formed. This means that during the test 77% of the nominal concentration was present.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The possible effect of prolonged exposure of monobromoacetic acid on the growth of juvenile zebra fish was determined in a 28 days test. The test substance was a 80% solution in water.
Growth, measured as weight, of control and exposed animals did not differ significantly at the end of the test. Therefore the NOEC for growth is >= nominal 100 mg/L; this corresponds with an actual concentration of 77 mg/L. The NOEC for survival and condition is therefore >= nominal 100 mg/L (= 77 mg/L actual).
Executive summary:

The possible effect of prolonged exposure of monobromoacetic acid on the growth of juvenile zebra fish was determined in a 28 days test. The test substance was a 80% solution in water. The results of the test are given in the concentrations of the active ingredient.

Because the range-finding test indicated that no adverse effects were to be expected, only one concentration of 100 mg/L was tested in a limit test. The test substance was dissolved directly into the dilution water by mixing appropriate amounts of labelled test substance with unlabelled material. The test was carried out under semi-static conditions, with 64 control fish (four replicates with 16 fish each) and with 32 fish (two replicates with 16 fish each) for the only concentration tested.

All exposure media were completely clear (visually assessed) throughout the test. During the test the actual concentration of monobromoacetic acid in the exposure media was determined by Liquid Scintillation Countings. The measured concentrations in the clean solutions were between 90% and 100% of the nominal value and thus confirmed the correct dosing of the test substance. During the test the actual concentration in the spent solutions decreased gradually; from 86% at t = 5 days to 37% at t = 26 days. The average percentage in the clean and spent solutions were 96% and 58% respectively. Specific analysis by HPLC showed that breakdown products were not formed. This means that during the test 77% of the nominal concentration was present.

Growth, measured as weight, of control and exposed animals did not differ significantly at the end of the test. Therefore the NOEC for growth is >= nominal 100 mg/L; this corresponds with an actual concentration of 77 mg/L.

With respect to the survival and the condition of the test fish there were no adverse effects observed throughout the test, except one dead fish at 100 mg at t = 5 days. As 10% mortality (in the control) is allowed this mortality is not taken into account as an adverse effect. The NOEC for survival and condition is therefore >= nominal 100 mg/L (= 77 mg/L actual).