Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The available evidence on degradation, bioaccumulation potential, and toxicity for 7a-ethyldihydro-

1H,3H,5H-oxazolo[3,4-c]-oxazole (CS-1246) indicates that the screening criteria for persistence (P),

bioaccumulation potential (B), and toxicity (T) are not met. Based on the information described below

for the relevant endpoints, CS-1246 is considered as not PBT/vPvB.

Table 45: Summary conclusion on PBT or vPvB properties

Constituent

P/vP

B/vB

T

7a-ethyldihydro-

1H,3H,5H-oxazolo[3,4-c]-

oxazole

EC no. 231-810-4

CAS no. 7747-35-5

Rapidly hydrolyzes (halflife

<4 hours at pH 4, 7,

and 9 at 25°C (The Dow

Chemical Company, 2003)

Conclusion: Not P/vP

based on definitive

criteria.

Measured log Pow is

-0.32 at 25°C (Sudworth,

2007)

Conclusion: Not B/vB

based on screening

criteria.

LC50/EC50 values96 hour=

130 mg/LLepomis

macrochirus(The Dow

Chemical Company, 1982)

LC50/EC5048 hour= 16.9 mg/L

forDaphnia magna(The

Dow Chemical Company,

2007)

EC5072 hr.= 1.08 mg/L

NOEL72 hr.= 0.513 mg/L

Selenastrum capricornutum

(The Dow Chemical

Company, 2002)

Conclusion: Not T based on

screening criteria

Degradation Product

P/vP

B/vB

T

2-amino-2-ethyl-1,3-

propanediol

CAS no. 115-70-8

AEPD degraded >90% in

7 days in inherent

biodegradation test (The

Angus Chemical

Company, 1996)

Conclusion: Not P/vP

based on screening

criteria.

Estimated log Pow is

–0.60 (KOWWIN version

1.67)

Conclusion: Not B/vB

based on screening

criteria.

LC50/EC50 values96 hour=

460 mg/L Leuciscus idus

melanotus L. (Institut für

gewerblische

Wasserwirtschaft und

Luftreinhaltung e.V.,1991)

This measured value is

consistent with predicted

ecotoxicity endpoints

which are greater than the

toxicity threshold for T.

Predicted acute toxicity

LC50/EC50values for

algae, water fleas, and fish

range from 8 to 770 mg/L

(ECOSAR version 1.00)

Conclusion: Not T based on

screening criteria.

Formaldehyde

CAS no. 50-00-0

Formaldehyde is readily

biodegradable, with 91%

biodegradation based on

BOD in 28 days in OECD

301C test (National

Institute of Technology

and Evaluation, Japan

(1989)

Conclusion: Not P/vP based on screening

criteria

Log Pow is 0.35 at 25°C.

(J. Sangster.1989. Octanol-

Water Partition

Coefficients of Simple

Organic Compounds.

J. Phys. Chem. Ref. Data,

18 (3), 1163)

Conclusion: Not B/vB

based on screening

criteria.

Alga is most sensitive

species for acute toxicity

of formaldehyde:

Desmodesmus

subspicatus, 72h-ErC50of

4.89 mg/L (Eisenträger A,

Dott W, Klein J, Hahn S

(2003) Comparative

studies on algal toxicity testing using fluorometric

microplate and

Erlenmeyer flask growthinhibition

assays.

Ecotoxicol Environ Safety

54: 346-354

Conclusion: Not T based on

screening criteria.