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DL-LACTONE CAS N°:79-50-5 - page 95 / 113

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OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

six groups consisted of 5 mal Micronucleus test The mean bodyweights of all s dosing, were not statisticall available). All animals treated with 375 abnormalities; this was also positive controls. Among the 1500-mg/kg-bw-groups, 7/20 we all animals were normal after Average numbers of micronucle per 2000 polychromatic erythr polychromatic to normochromat

es and 5 females.

ix groups, recorded just before y different (data

and 750 mg/kg bw showed no true for both the negative and 20 animals in the two re lethargic at the beginning but

19 hours. ated polychromatic erythrocytes ocytes and ratios of ic erythrocytes:

Group

Dose,

mg/kg bw

Sampling

Number,

Ratio,

time, h

mean±SD

mean±SD

Males

A,

vehicle control

0

B,

dl-lactone

1500

C,

dl-lactone

1500

D,

dl-lactone

750

E,

dl-lactone

375

F,

Cyclophosphamide

50

24

1.0±1.1

1.21±0.12

24

0.4±0.5

0.89±0.10

48

0.4±0.5

0.95±0.21

24

1.2±1.3

1.08±0.15

24

1.4±0.5

1.48±0.12

48

45.6±24.6** 0.32±0.10

Females

24

0.2±0.4

1.31±0.17

24

0.8±1.1

1.17±0.09

48

1.0±1.4

1.17±0.11

24

0.6±0.9

1.24±0.23

24

0.8±0.8

1.13±0.10

48

20.4±2.6**

0.36±0.10

A,

vehicle control

0

B,

dl-lactone

1500

C,

dl-lactone

1500

D,

dl-lactone

750

E,

dl-lactone

375

F,

Cyclophosphamide

50

Test substance:

Conclusion:

Reliability:

Flag: 24-SEP-2004

All single

data are

dl-Lactone

from Roch

according t

o analyti

dl-Lactone

at an ora

increase in

the inci

polychromat

ic erythr

Therefore,

lactone i

genotoxic e

ffects in

Further, th

e test gr

any decreas

e in the

erythrocyte

s, which

dl-lactone

on erythr

However, 4/

8 animals

mg/kg bw di

ed within

(1500 mg/kg

bw) dose

nor in the

treatment

(1) valid

without r

OECD study

under GLP

** Signific group, P <=

antly dif

0.01.

Critical

study

for

S

ferent from negative (vehicle) control

available in the report. e Dalry, batch no. BX226, purity 99.8% cal certificate. l dose of 1500 mg/kg bw did not induce any dence of micronucleated ocytes in this in vivo mouse test. s regarded as negative regarding

this model. oups treated with dl-lactonedid not show ratio of normochromatic to polychromatic reflects a lack of toxic effects of opoiesis.

in the high-dose range-finder at 2000 1.5 hours. No animal in either the lower range finding study (3 males, 3 females) groups died. estriction , reliability 1. IDS endpoint

(33)

5.7 Carcinogenicity

5.8.1 Toxicity to Fertility

Type:

other: combined repeat dose and reproductive toxicity screening test

UNEP PUBLICATIONS

95

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