Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sucrose di(acetate) hexaisobutyrate
EC Number:
204-771-6
EC Name:
Sucrose di(acetate) hexaisobutyrate
Cas Number:
126-13-6
IUPAC Name:
Sucrose Acetate Isobutyrate
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SAIB-100 (Sucrose Acetate Isobutyrate)
- Physical state: Yellow viscous liquid
- Lot/batch No.: A526-00667
- Expiration date of the lot/batch: 6/11/13
- Storage condition of test material: Room temperature in the dark

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
A fresh stock solution was prepared 3 times a week, and the test exposure solutions were prepared and replaced three times a week. Samples of each fresh solution and each aged solution were collected for analytical concentration verification. The pH value, dissolved oxygen and temperature were measured immediately after initiating the test for the controls and each test concentration. Measurements were also recorded at each occasion on the new medium and on pooled replicates of the old medium, after transfer of the parent animals.

Test solutions

Vehicle:
no
Details on test solutions:
The test material is believed to be relatively insoluble with water; therefore the test concentrations were prepared as water accommodated
fractions (WAFs) by mixing the test sample in dilution water for at least 44 hours followed by at least a 4 hour settling period. Each test concentration was prepared individually. A fresh stock solution was prepared 3 times a week, and the test exposure solutions were prepared and replaced three times a week.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Adult gravid Daphnia magna isolated on April 25, 2013 and less than 24 hour old neonates were subsequently collected and used for the study.

Study design

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

Test conditions

Hardness:
199.88mg/L as CaC03
Test temperature:
The recorded temperatures of the test solutions were in the range 19.4 to 21.5°C.
pH:
The pH was in the range 7.22 to 8.18.
Dissolved oxygen:
fresh solutions: 6.5 to 9.74 mg/L
aged solutions: 4.75 to 8.58 mg/L except for day 21 samples where the range was 2.2-3.86
Nominal and measured concentrations:
Nominal loading rates in the WAF solutions were 6.3, 12.5, 25, 50, and 100 mg/L
Time weighted mean measured concentrations were 0.0456, 0.0582, 0.0622, 0.0684, and 0.0989 mg/L
Details on test conditions:
The test substance nominal concentrations were prepared as "water-accommodated fractions" by stirring the appropriate quantities of test material in Daphnia test media for 44 hours, followed by a settling period of 4 hours. For each test concentration, a wide bore glass tube was used to transfer one Daphnia, in the minimum amount of culture water (<0.5 ml), into ten replicate 100ml glass beakers. Each beaker contained 80ml of the test sample concentration. Ten control vessels were prepared as 80ml of dilution water, each containing a single Daphnia. The test vessels were then placed into an incubator at a temperature of 20 ± 1 °C with a light cycle of sixteen hours light and eight hours dark, with diffuse incident illumination not exceeding 1500lux. The test vessels were not aerated during the test period. To limit aerial contamination of the test vessels and reduce evaporative losses, a transparent perspex sheet was placed over the tops of the beakers. A fresh stock solution was prepared 3 times a week, and the test exposure solutions were prepared and replaced three times a week. The mortality of the parent Daphnia and the number of offspring produced by each parent animal were recorded every working day. The presence, if any, of aborted eggs or dead offspring were also recorded and removed along with the live neonates. The parent Daphnia were fed daily with 0.3-0.5 ml of a unicellular algal suspension (Chlorella vulgaris), which equates to 0.1 mg organic carbon per litre of test solution.

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.099 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.099 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The number of live offspring produced per parent animal surviving to the end of the test in the control vessels was 91 to 165, with a mean value of 123. The coefficient of variation for control fecundity was calculated as 19.0%.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The toxicity of SAIB-100 (Sucrose Acetate Isobutyrate) was evaluated according to the procedures of OECD 211: Daphnia magna Reproduction Test in a 21 day exposure. The test material is believed to be relatively insoluble in water; therefore the test concentrations were prepared as water accommodated fractions (WAFs) by mixing the test sample in dilution water for at least 44 hours followed by at least a 4 hour settling period and removal of the dissolved portion for testing. Five WAF concentrations ranging from 6.3 to 100 mg/L loading rates were prepared individually and tested along with a control. Fresh WAF solutions were prepared 3 times a week, and the test exposure solutions were also replaced three times a week. The mortality of the parentDaphniaand the number of offspring produced by each parent animal were recorded every working day. Statistical analyses of the No Observable Effect Concentrations (NOEC) were calculated for parental survival and fecundity (reproduction). The 21-day NOELR or NOEC for both parentDaphniasurvival and fecundity was determined to be the highest tested concentration; NOELR =100 mg/L or 0.0989mg/L based upon the time weighted mean measured concentration.  The results show that there are no effects at the limit of water solubility.