Androst-5-ene-17-carbonitrile, 3,3-[1,2-ethanediylbis(oxy)]-17-hydroxy-, (17.alpha.)-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

Name of test material (as cited in study report)
- Lot/batch No.: 58034/001-0048 (mixed batches)

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1.5 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

No immobilized Daphnia were observed in the test solutions with 1.5 mg/l test substance (mean value, saturated solution).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50 48 hours of DA-Cyanhydrin-3-Ethylenketal to Daphnia magna is expected to be higher than a saturated
solution (1.5 mg/I). Since the pH adjustment did not prevent the solution to increase in pH to > 8, it is possible that hydrolysis products occurred in both test solutions.

Executive summary:

The purpose of this study was to determine the acute toxicity (immobilization, EC50/48 hours) of DA-Cyanhydrin-3-Ethylenketal with Daphnia magna in order to evaluate the aquatic toxicity. DA-Cyanhydrin-3-Ethylenketal is an intermediate of the synthesis of different hormones. The test compound was hydrolytically unstable (half-life 40.4 hours/pH 7).

The study was conducted as a limit test (under semi-static conditions) in agreement with the OECD guideline, no. 202.

For the preparation of the test solution, a suspension of 100 mg/I was stirred for 24 hours. An

identical suspension was prepared and adjusted to pH 7 with 1 M HCL, since the hydrolytic

stability was proposed to be very low at higher pH.

The organic carbon concentration of the test solutions were analyzed with a TOC analyzer at the start of exposure as weil as 24 and 48 hours thereafter. The mean concentration for both solutions was calculated with 1.5 mg/I.

The test temperature was in the range of 19.7 to 20.4°C, the pH ranged between 7,1 and 8.4.

No significant differences were observed between the pH adjusted and non pH adjusted

solution, since the pH increased in the adjusted solution to almost the same value as the nonadjusted

within 24 hours.

The EC50/48 hours of DA-Cyanhydrin-3-Ethylenketal to Daphnia magna is higher than a saturated solution

(1.5 mg/I) as determined by TOC analysis.