Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 - 30 Nov 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Niedersächsisches Umweltministerium, Hannover, Germany

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

EC Number:

906-521-8

Cas Number:

85391-60-2

Molecular formula:

C8H16N2O6

IUPAC Name:

Reaction mass of 2-hydroxyisopropyl 2-hydroxypropyl bicarbamate and 2-hydroxypropyl carbazate and propylene carbonate

Test material form:

liquid

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 100 mg/L
- Sampling method: Samples were taken from the test solutions and an additional replicate without test organisms (duplicate samples).

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 200 mg test substance was applied to 2 L of test medium. The solution was shaken with 20 rpm for 24 h. Thereafter, the dispersion was centrifuged (20 min, 3000 rpm) to remove undissolved particles.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Aquarium am Aegi, Hannover, Germany
- Maintenance of the brood fish: Holding was performed at 23 ± 2 °C and diffuse light. Water was changed at least once per week. No disease treatments were administered throughout holding and testing.
- Length at study initiation: 2.67 cm
- Weight at study initiation: 0.2 g

ACCLIMATION
- Acclimation period: at least 12 d (mortality < 5% within the last 7 d of acclimatisation)
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: Trouvit 40 / 2, Milkivit; Bürgheim, Germany
- Feeding frequency during acclimation: Three times a week (4% of fish body weight per day); Fish were not fed until 24 h before test start.

FEEDING DURING TEST
- None

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

76 mg/L as CaCO3

Test temperature:

21.0 - 22.5 °C

pH:

7.04 - 7.53

Dissolved oxygen:

100% oxygen saturation

Nominal and measured concentrations:

nominal: control, 100 mg/L
measured DOC: please refer to "Any other information on results incl. tables"

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria with test volume of 2 L per vessel.
- Type (delete if not applicable): loosely covered by glass tops
- Aeration: gentle aeration was provided
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water of local origin; water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine
- Total hardness: 40 - 180 mg CaCO3/L
- pH: 6.0 - 8.0
- Culture medium different from test medium: same as test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: natural photoperiod
- Light intensity: 0.1 - 10 µmol/m²*s

EFFECT PARAMETERS MEASURED
- Mortality was recorded after 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable, limit test
- Range finding study
- Test concentrations: One limit Water Accommodated Fraction (WAF) was tested incl. a control
- Results used to determine the conditions for the definitive study: No mortality was recorded. Thus, a limit test is justified.

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%

Reported statistics and error estimates:

Since no effects were recorded, no statistical analysis was necessary.

Any other information on results incl. tables

Sublethal observations / clinical signs:

Table 1: Results from DOC analysis

Nominal loading [mg/L]	DOC [mg/L]
	Parallel determination				Mean
	0 h		96 h		0 h	96 h
100	--	--	46.5	47.0	--	46.8
100*	43.3	43.5	42.8	43.1	43.4	43.0
Control	--	--	6.4	6.5	--	6.5
Control*	1.6	1.6	1.7	1.8	1.6	1.8

* test loading without test organisms

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Mortality in control: 0%; O2 saturation: 100%