Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
acute, 96 hours, 26 to 30 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline andd GLP-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
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): BEPD
- Physical state: colourless solid
- Analytical purity: 99.5%
- Lot/batch No.: HRC accession number 20.4.95/1
- Expiration date of the lot/batch: 31 December 1995.
- Storage condition of test material: in darkness at room temperature (ca. 20 degrees C).
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:
Samples were taken of fresh media at 0 and 72 hours. Samples were taken of expired media at 24 and 96 hours.

Test solutions

Vehicle:
no
Details on test solutions:
Test substance was dispersed directly in test water with the aid of ultrasonic disruption for 30 minutes.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Test organism:
- Common name: rainbow trout
- Source: Westacre Trout Farm, Norfolk, UK

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

Test temperature:
15 - 16°C
pH:
7.4 - 7.8
Dissolved oxygen:
8.9 - 9.4 mg/L
Nominal and measured concentrations:
Nominal: 0 (control), 4.6, 10, 22, 46 and 100 mg/L
Measured: 0 (control), 4.7, 11, 23, 45 and 100 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
3 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
6 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
23 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks:
and sublethal effects
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

No evidence of precipitate or undissolvedBEPD in the test vessels.

Results of the definitive test are compiled below:

Nominal BEPD concentration (mg/L)

Mean BEPD concentration (mg/L)

Mortality after 96 hours (%)

0 hours

24 hours

72 hours

96 hours (E)

Mean

Mean as % of nominal

Control

ND

ND

ND

ND

-

-

0

4.6

4.439

4.257

5.052

5.218

4.7

103

0

10

9.600

9.216

11.89

11.57

11

106

0

22

21.78

20.79

25.00

24.02

23

104

0

46

45.71

42.42

47.12

46.08

45

99

0a

100

97.43

94.05

110

108

102

102

0b

ND: None detected

E: Expired media

a: Several fish exhibited increased pigmentation and lying on the bottom, singly or in combination. One showed loss of equilibrium.

b: All fish exhibited a combination of lethargy, lying on the bottom, swimming on the surface, partial loss of equilibrium and hyperactivity. All showed increased pigmentation.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour LC50 of BEPD to O. mykiss under semi-static conditions was >100 mg BEPD/L (mean measured).
The NOEL (no-observed effect level) was 23 mg BEPD/L.
Executive summary:

JuvenileO. mykisswere exposed to BEPD at nominal concentrations of 4.6, 10, 22, 46 and 100 mg/L in a semi-static 96 -hour acute toxicity test according to OECD 203 guidelines. The test design included an untreated control comprising of dilution water only. Concentrations of BEPD were verified analytically at test initiation and termination and mean measured concentrations were 92 to 119% of nominal. The 96-hour LC50 determined was >100 mg BEPD/L (mean measured). The NOEC (no-observed effect concentration) was 23 mg BEPD/L (Bell, 1995).