Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
other information
Study period:
09. Oct to 08. Dec 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported, guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
3-oxopregn-4-ene-21,17α-carbolactone
EC Number:
213-552-4
EC Name:
3-oxopregn-4-ene-21,17α-carbolactone
Cas Number:
976-70-5
Molecular formula:
C22H30O3
IUPAC Name:
(1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
Details on test material:
- Name of test material (as cited in study report): Aldona (ZK 57564)
- Analytical purity: 95.5%
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
ca. 16.6 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48
Dose descriptor:
LOEC
Effect conc.:
ca. 29.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
ca. 26.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 29.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The no-observable effect-concentration (NOEC) of aldona on mobility (48 h) is 16.6 mg/l
Executive summary:

The aquatic toxicity was studied in an acute immobilization test with Daphnia magnaa ccording to test guideline OECD 202. The daphnids were exposed over 48 hours to 5 concentrations of the test substance between 2.8 and 29.8 mg/L, measured by TOC analysis and a control. There was a concentration related immobilization. The EC50/24h of aldona was higher than 29.8 mg/L, the EC50/48 hours was determined with 26.9 mg/L. The NOEC/48h was 16.6 mg/L, the LOEC/48h was 29.8 mg/L.