Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-07-10 to 2016-07-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

The limit loading and the control were analytically the test item verified from freshly prepared media after 0 and 72 hours and from corresponding aged test media after 24 and 96 hours.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water Accomodated Fraction, aqueous media were prepared by mixing the test item with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase. After completion of mixing and following a settlement period, the test item phase was separated by siphon and the test organisms were exposed to the aqueous phase, the WAF (which may contain dissolved and/or suspended and/or emulsified fractions of the test item mixture).
- Controls: dilution water (without test item)
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): 32 mg/L nominal loading when WAF was prepared.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Source: Umweltbundesamt, Schichauweg 58, 12307 Berlin, Germany
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1.0 cm
- Maintenance of the brood fish: at 23 ± 2 °C and diffuse light (7 - 750 lux, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80% of the air saturation value.

ACCLIMATION
- Acclimation period: At least 12 days
- Acclimation conditions (same as test or not): same as test conditions
- Type and amount of food during acclimation: Sera Vipan; SERA GMBH, 52518 Heinsberg, Germany, Amount: 4% of the fish body weight/feeding day
- Feeding frequency during acclimation: 3 times/week
- Health during acclimation (any mortality observed): < 5% mortality

FEEDING DURING TEST
- Food type: No feeding during test (+24 h before the test start)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

10-250 mg/CaCO3/L

Test temperature:

23 ± 2 °C

pH:

6.0-8.5

Dissolved oxygen:

> 80%

Conductivity:

172 µS/cm

Nominal and measured concentrations:

Nominal 32.0 mg/L, measured concentration of Carbon [mg C/L]: 18.0 at 0 h
23.5 at 24 h
18.0 at 72 h
23.9 at 96 h

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria of 3 L were used (dimensions: 11.5/13/20 cm) and covered with glass plates.
- Type (delete if not applicable): closed
- Aeration: Gentle aeration was provided
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Total organic carbon: 18 mg/L
- Alkalinity: 0.60 mmol/L
- Culture medium different from test medium: No
- Intervals of water quality measurement: Quaterly

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/ 8 h dark corresponding to natural daylight hours
- Light intensity: 7-750 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Observations were made after 3, 24, 48, 72 and 96 h. Fish were considered dead if there was no visible movement (e.g. gill covvers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalties (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.). For measurements of the size and weight the control fish were used at the end of the exposure.

TEST CONCENTRATIONS
- Range finding study: Not necessary due to prior acute toxicity studies, e.g. to invertebrates and algae.
- Test concentrations: 32 mg/L

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LL100

Effect conc.:

> 32 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: not observed
- Observations on body length and weight: no abnormalities observed
- Mortality of control: 0%

Sublethal observations / clinical signs:

Table 1) Observations in the test vessels

Nominal test item loading [mg/L]	Effect *)	Number of fish effected after different periods [hours]
		3	24	48	72	96
32.0	(1)	7/7	7/7	7/7	7/7	7/7
control	(1)	7/7	7/7	7/7	7/7	7/7

*) The numbers in brackets correspond to the following observations:

(1) = Normal behaviour

 

Table 2: Cumulative Mortality [%] in the Test Vessels

Nominal test item loading [mg/L]	Cumulative Mortality [%] after different exposure periods [hours]
	3	24	48	72	96
32.0	0	0	0	0	0
control	0	0	0	0	0

 

Validity criteria fulfilled:

yes

Conclusions:

The 96-h LC50 of polyglycerin caprylate/caprinate to zebrafish was > 32 mg a.i./L.

Executive summary:

In a 96-h acute toxicity study according to OECD Guideline 203 (1992) and EU method C.1 (2008), Danio rerio were exposed to polyglycerin caprylate/caprinate in nominal concentrations of 0 (control) and 32 mg a.i./L under semi static conditions. 

No mortality or sublethal effects were observed at the limit concentration and the control during the 96-hour test period. The 96-h LC50 was > 32 mg a.i./L.  The EC50 and NOEC values, based on mortality, were also >32 mg a.i./L. 

 

Results Synopsis

Test organism size (mean wet length): Danio rerio, 2.6 cm (2.4 – 2.7 cm)

Test Type: Semi-Static

96 h LC50:  > 32 mg a.i./L                         95% C.I.:  n.d.

Endpoint Effected: mortality

Description of key information

96 h LC50:  > 32 mg a.i./L (OECD TG 203/ EU method C.1; RL1; GLP: semi-static, Danio rerio)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

32 mg/L

Additional information

In a 96-h acute toxicity study according to OECD Guideline 203 (1992) and EU method C.1 (2008), Danio rerio were exposed to polyglycerin caprylate/caprinate in nominal concentrations of 0 (control) and 32 mg a.i./L under semi static conditions. 

No mortality or sublethal effects were observed at the limit concentration and the control during the 96-hour test period. The 96-h LC50 was > 32 mg a.i./L.  The EC50 and NOEC values, based on mortality, were also >32 mg a.i./L.