Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study according to internationally accepted guideline. No deviations from guideline protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

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): PAC
Lot/Batch number: 5 A 7990
Specification
Purity: 99.48%
Water solubility: 200 mg/l

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
Daily preparation of a stock solution containing 500 mg/l of substance and 0.01% of methylcellulose, used as solubility coadjuvant agent. Solution made with the aid of an ultrasonic device.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Source: Incontri con la natura, Ciriè (Torino), Italia.
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 3,5 cm
- Weight at study initiation (mean and range, SD): 0,404 g
- Method of breeding: no data
- Feeding during test: no

ACCLIMATION
- Acclimation period: 1 month
- Acclimation conditions (same as test or not): not stated
- Type and amount of food: Feed JBL-JBL during the acclimation period, amount not stated
- Feeding frequency: daily

Study design

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

Test conditions

Hardness:
50 mg CaCO3/L
Test temperature:
23°C
pH:
see table "Test conditions"
Dissolved oxygen:
see table "Test conditions"
Nominal and measured concentrations:
Nominal: 500 mg/L. The treatment solutions were changed every 24 h. The analyses of the actual concentrations were performed at 0 and 24 h of the treatment period, indicating a good correlation between nominal and measured concentrations (less than 10% of variation).
But the data of the analytical measurements are not present in the report.

Details on test conditions:
TEST SYSTEM
- Type: semistatic
- Volume of test vessel: 10 L
- Aeration: no
- Renewal rate of test solution (frequency): daily interval
- No. of organisms per vessel: 10 animals/vessel
- No. of vessels per concentration (replicates): 1 vessel/concentration
- No. of vessels per control (replicates): 1 vessel
- No. of vessels per vehicle control (replicates): 1 vessel

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water from the municipal main system.

OTHER TEST CONDITIONS
- Photoperiod: 12/16h photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Test concentrations: 500 mg/L (limit test)

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality
Details on results:
No mortality, no observed adverse effects

Any other information on results incl. tables

Loss in concentration of the test substance over test period: 4.34 %

Validity criteria for acute fish test according to OECD Guideline 203:

 

fulfilled

Not fullfilled

Mortality of control animals <10%

YES

 

Concentration of dissolved oxygen in all test vessels > 60% saturation

YES

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
see above
Conclusions:
No mortality was observed. The substance is not toxic to fish.
Executive summary:

The acute toxicity of PAC in B. rerio was studied by means of a semi-static test. 10 fish/group were exposed to 0 and 500 mg/l PAC in aqueous 0.01% methylcellulose. A further group of 10 fish was exposed to water in the absence of vehicle. The exposure lasted for 96-hours and the solutions were changed every 24 hours. Analyses of the test substance solutions were performed at 0 and 24 hours of the treatment period, indicating a good correlation between nominal and measured concentrations (less than 10% of variation).