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DL-LACTONE CAS N°:79-50-5 - page 69 / 113

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Method:

other: Roche gavage oral toxicity test

Year:

1976

GLP:

no

OECD SIDS 5. TOXICITY

Value:

= 4380 mg/kg bw

Test substance:

as prescribed by 1.1 - 1.4

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Method:

As usual for this internal Roche testing scheme, groups of 5 or 10 animals per dosage were used. Administration was by gavage. Observation was 10 days after administration, then the test animals were killed and dissected. Statistics were computed if applicable. Controls were historical with the same

Result:

Test substance:

Lethal dose

Time after gavage

24 h

10 d

LD10, mg/kg

3400

2860

LD50, mg/kg

5300±840

4380±670

LD90, mg/kg

8300

6710

mouse strains.

"dl-Lactone (pure)"

percentage.

, Mag-No 4 3576 1, no information on actual

Conclusion:

Pure dl-lactone has a relatively low oral toxicity to mice with an LD50 of 4380 mg/kg bw; the range between LD10 and LD90 is 2860-6710 mg/kg bw. The lethal doses were approximately one-fifth higher at 24 hours than at 10 days, showing that while in mice pure dl-lactone exerts its low toxicity rapidly,

for the greater part within the first 24 hours, there is a comparatively weak additional toxic effect after this initial

Reliability:

period in mice. (2) valid with While this test

restrictions is reported only

in

very

abbreviated

form,

the acute performed

toxicity group led by the author of large series of highly standardised

the report toxicity tests

in the late 1960s, dedicated facility

1970s and early 1980s. Serial testing in a assures dependably regular animal keeping,

Flag: 26-AUG-2004

test substance administration, laboratory protocol and reporting. Therefore these internal data are regarded as and dependable. Critical study for SIDS endpoint

valid

(12)

Type:

LD50

Species:

rat

Strain:

other: Roche inbred strain

Sex:

no data

Vehicle:

no data

Doses:

highest dose 8000 mg/kg bw

Value:

> 8000 mg/kg bw

Method:

Year: GLP: Test substance:

other: Roche gavage oral toxicity test 1976 no other TS

Method:

As usual for this internal Roche testing scheme, groups of 5 or 10 animals per dosage were used. Administration was by gavage. Observation was 10 days after administration, then the test animals were killed and dissected. Statistics were computed if applicable. Controls were historical with the same rat strains.

UNEP PUBLICATIONS

69

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