Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Remarks:
As per ICCA HPV review conducted by Haskell.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 40 CFR Part 797.1330 Daphnid chronic toxicity test. Environmental effects testing guidelines.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99.8%

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Solutions for quantitative analysis were taken from controls and selected test solutions at 0, 7, 14, and 21 days of the study. Two replicates per concentration were selected using random numbers on each sample day.

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d

Test conditions

Nominal and measured concentrations:
Nominal: 0.0066, 0.016, 0.041, 0.1, 0.26, 0.64, and 1.6 mg/L
Measured: Lowest concentration was below detection limit, 0.0027, 0.021, 0.065, 0.18, 0.54, and 1.5 mg/L, respectively
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: Pyrex beakers 250 mL; 6.1 cm diameter
- Aeration: Unaerated
- No. of organisms per vessel: 4
- No. of vessels per concentration (replicates): 10

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.065 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.54 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.18 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.67 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
mortality
Remarks on result:
other: 0.57-0.83 = 95% fiducial interval
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.46 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
reproduction
Remarks on result:
other: 0.33-0.77 = 95% fiducial interval
Reported statistics and error estimates:
For length: Jonckherre's trend test and Kruskal-Wallis and Dunn's multiple comparison test.

Any other information on results incl. tables

Mean Measured Concentration

(mg/L)

Percent Adult Survival

1stReprod Day

Total Young

Young/Surv. Parent

Immobilized Young

Length

(mm)

Control

93

8.0

399

105

0

4.5

0.0066

88

8.0

340

93

0

4.5

0.0027

95

8.0

355

93

0

4.5

0.021

95

8.1

372

96

0

4.5

0.065

85

8.1

324

93

0

4.4

0.18

95

8.0

319

82

0

4.3

0.54

55

12

64

30

3.5

3.8

1.5

0

D

D

D

D

D

D = all dead

Applicant's summary and conclusion

Conclusions:
This study established a 21-day EC50 (mortality) and EC50 (reproduction) for o-phenylenediamine in daphnids of 0.67 and 0.46 mg/L, respectively. The NOEC established by this study was 0.065 mg/L o-phenylenediamine.
Executive summary:

Nominal test concentrations of oPDA were 0.0066, 0.016, 0.041, 0.10, 0.26, 0.64 and 1.6 mg/L. The lowest concentration (0.0066 mg/L) was below the present limit of quantitation and was not analyzed. The remaining mean, measured concentrations were 0.0027, 0.021, 0.065, 0.18, 0.54, and 1.5 mg/L, respectively. The number of adults surviving to day 21 was statistically significantly reduced at 0.54 mg/L and above. The total number of young and the total number of young produced per surviving adult in 21 days was statistically significantly reduced at 0.18 mg/L and above. Length was statistically significantly reduced at 0.065 mg/L and above using Jonckheere's trend test. However, length at 0.065 mg/L was not statistically significant using Kruskal-Wallis and Dunn's multiple comparison test. In addition, length at 0.065 mg/L was not considered biologically significant based on the slight decrease in average measurement compared to control, the variability between replicates, and the lack of precision in measuring daphnid length. The 21-day EC50, based on adult survival and nominal concentrations, was 0.67 mg/L. The 21-day EC50, based on the total number of young produced per surviving adult in 21 days and nominal concentrations was 0.46 mg/L. The 21-day NOEC was 0.065 mg/L and 21 -day MATC was 0.11 mg/L, based upon adult reproduction and length.