Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 August 1993 - 02 September 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to an appropriate OECD test guideline, and a statement of GLP compliance is included in the report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
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:
- Name of test material (as cited in study report): dimethylolpropionic acid or 2,2-bis(hydroxymethyl)propionic acid (reported as Bis-MPA in this summary)
- Lot/batch No.: 63004-14
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Portions of the stock and test solutions were sampled and delivered to the sponsor for analysis.

Test solutions

Vehicle:
no
Details on test solutions:
Not applicable

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish

ACCLIMATION
- Acclimation period: 14 days in internal quarantine.

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:
250 ± 25 mg calcium carbonate/L (nominal value)
Test temperature:
24±1ºC (nominal value)
pH:
6.5 - 8.7 (recorded values)
Dissolved oxygen:
60 - >100% (recorded values)
Salinity:
Not applicable
Nominal and measured concentrations:
0, 100, and 1000 mg/L (nominal values)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): not specified
- Material, size, headspace, fill volume: 5 L glass vessels
- Aeration: test solutions were aerated prior to use (>90% oxygen saturation)
- Renewal rate of test solution (frequency/flow rate): test solutions were renewed every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.6 grams of fish per litre


OTHER TEST CONDITIONS
- Adjustment of pH: Not reported, although adjustment (to pH 7.8 ± 0.2) permitted using NaOH or HCl as appropriate.
- Photoperiod: 16 hour light, 8 hours dark.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality.

Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No treatment related mortalities occurred during the test period.
Results with reference substance (positive control):
The sensitivity of the fish population used for potassium dichromate was 366 mg/L which is in accordance with the Swedish Standard SS 02 81 62
Reported statistics and error estimates:
Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
An acute semi-static toxicity study in zebra fish (Brachydanio rerio) was performed to assess the toxicity of Bis-MPA. The study was performed to GLP and according to OECD 203 Test Guideline. No mortalities were observed during the test and the LC50 value over the 96 hour test period was observed to be >1000 mg/L (based on nominal exposure concentrations).
Executive summary:

A 96 hour acute semi-static toxicity study in zebra fish (Brachydanio rerio) was performed to assess the toxicity of Bis-MPA. The study was performed to GLP and according to OECD 203 Test Guideline. No mortalities were observed during the test and the LC50 value over the 96 hour test period was observed to be >1000 mg/L (based on nominal exposure concentrations).