2-amino-2-ethylpropanediol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Feb - 12 Mar 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

yes

Remarks:

Water hardness was 31 mg/L.

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 35 - 37 °C
- Boiling point: 152 - 153 °C
- Water solubility (under test conditions): 1000 g/L (at 25 °C)
- log Pow: -0.60

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Sampled by one vessel of each concentration directly. The freshly prepared test solution was measured on Day 0, 10 and 19. The old test solution before renewal was analyzed on Day 3, 12 and 21.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Incorporated Administrative Agency, National Institute for Environmental Studies, Tsukuba, Japan
- Age of parental stock (mean and range, SD): within 24 hours
- Feeding during test: Yes
- Food type: Chlorella vulgaris
- Amount: 0.15 - 0.2 mgC/day

ACCLIMATION
- Acclimation period: 21 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Chlorella vulgaris, 0.15 - 0.2 mgC/day
- Health during acclimation (any mortality observed): mortality of parental animal was < 5%.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

30 - 34 (CaCO3) mg/L

Test temperature:

20.4 - 20.5 °C

pH:

7.4 - 9.4

Dissolved oxygen:

7.2 - 8.4 mg/L

Nominal and measured concentrations:

Nominal concentration: 4.6, 10, 22, 46, 100 mg/L
Measured concentration: 3.99, 8.61, 18.7, 41.1, 88.5 mg/L (time-weighted mean measured concentration during 21 days)

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL screw lid glasses
- Material, fill volume: Glass, 80 mL
- Renewal rate of test solution (frequency/flow rate): three times in a week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: charcoal-treated, dechlorinated and aerated tap water in Fukushima, Japan
- Alkalinity: 21.9 mg/L
- Ca/mg ratio: 8.5/1.9
- Culture medium different from test medium: same medium

OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment of pH
- Photoperiod: 16 hours in the light and 8 hours in the dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
LC50 for parental animals, EC50 for reproduction, the cumulative numbers of juveniles, first brood production

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: EC50 for immobilisation for 48 hours was > 100 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (reagent grade)

Duration:

21 d

Dose descriptor:

LC50

Effect conc.:

47 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

of parental daphnia

Remarks on result:

other: 34.8 - 66.2 mg/L

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

59.8 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: 44.4 - 93.6 mg/L

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

3.99 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

8.61 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

- Mortality of parent animals: See Table 1.
- No. of offspring produced per day per female: See Table 2.
- Time to first brood release or time to hatch: Control: 7 - 9 days, concentration group: 8 - 10 days

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- Relevant effect levels: EC50: 0.01 - 0.13 mg/L

Reported statistics and error estimates:

Dunnett's multicomparison test was used for NOEC and LOEC

Table 1. Mortality (%) of parental Daphnia

Nominal concentration (mg/L)	Days
	1	2	4	7	14	21
Control	0	0	0	0	0	0
4.6	0	0	0	0	0	0
10	0	0	0	0	0	0
22	0	0	0	0	0	0
46	0	0	0	0	0	30
100	0	0	0	20	100	100

Table 2. Cumulative numbers of juveniles produced per adult alive for 21 days

Nominal concentration (mg/L)	Mean (a) measured concentration (mg/L)	Mean Cumulative Numbers of Juveniles ± S.D.	Inhibition Rate (%)	Significant difference
Control	-	160.7 ± 8.5
4.6	3.99	150.7 ± 10.2	6.2	N.S.
10	8.61	142.2 ± 9.1	11.5	p < 0.01
22	18.7	127.7 ± 10.6	20.5	p < 0.01
46	41.1	90.6 ± 7.0	43.6	p < 0.01
100	88.5	- *	-

(a): Time-weighted mean measured concentration

*: Were not calculated because the parental Daphnia was dead during 21 -days testing period.

N.S.: Indicate no-significant difference

Description of key information

NOEC(21d) = 3.99 mg/L for Daphnia magna (OECD 211)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

3.99 mg/L

Additional information

There is one long-term study with aquatic invertebrates available for 2-amino-2-ethyl-1,3-propanediol (AEPD), which was used as key study for the assessment. The study was conducted according to OECD guideline 211 and GLP (MOE, 2004). The test organism Daphnia magna was exposed to AEPD in a semi-static system for 21 days, at test concentrations of 3.99, 8.61, 18.7, 41.1, 88.5 mg/L (TWA). As a result, a NOEC based on reproduction of 3.99 mg/L was obtained.