X hits on this document

PDF document

DL-LACTONE CAS N°:79-50-5 - page 104 / 113

379 views

0 shares

0 downloads

0 comments

104 / 113

OECD SIDS 5. TOXICITY

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Conclusion:

certificate of dl-Lactone was female Wistar bw/d. The male during mating The females we mating, during The mean durat females was 43 of 56 days. Parental toxic clinical signs observations, examination, o mg/kg bw/d, no

analysis. administered by daily oral gavage to male and rats at dose levels of 40, 200 or 1000 mg/kg s were exposed for 2 weeks prior to mating, and up to termination (28 days for all males). re exposed for 2 weeks prior to mating, during

post-coitum and at least 4 days of lactation. ion of treatment of

days, with a minimum of 28 days and a maximum

ity was assessed by observing mortality, , body weights, food consumption, functional clinical laboratory investigations, macroscopic rgan weights and microscopic examination. At 40

parental toxicity was observed. At 200 mg/kg

bw/d, no parental toxicity was observed. At 1000 parental toxicity consisted of clinical symptoms and restless behaviour) in females during days 5 treatment and of increased serum potassium level

mg/kg bw/d, (aggressive to 15 of in males.

Reproductive toxicity was assessed by observing the mating performance, fertility indices and number of pups at birth. No reproductive toxicity was observed up to 1000 mg/kg bw/d. Breeding toxicity was assessed by observing the number of postnatal and breeding loss during lactation. No breeding toxicity was observed up to 1000 mg/kg bw/d. Developmental toxicity was assessed by observing clinical signs, body weights and macroscopic examination of the pups during their lactation period. No developmental toxicity was observed up to 1000 mg/kg bw/d. In conclusion, gavage treatment of male and female Wistar rats with dl-Lactone at dose levels of 40, 200 or 1000 mg/kg bw/d for at least 28 days (during premating, mating, post-coitum and lactation) revealed slight parental toxicity in animals receiving 1000 mg/kg bw/d; this toxicity was transient during the study in the case of the females, while the males were killed after 28 days so that potential recovery could not be assessed. Reproductive, breeding and developmental parameters were unaffected up to 1000 mg/kg bw/d. Based on the results in this combined repeated dose toxicity

study with reproduction/developmental screening test, definitive suc-chronic parental NOAEL was established

200 mg/kg bw/d. The definitive reproductive,

breeding

the as being and

developmental NOAEL was established as being 1000 mg/kg bw/d.

Reliability:

(1)

valid without restriction

Flag: 15-MAR-2005

OECD test under GLP. Critical study for SIDS

endpoint

(5)

5.8.2 Developmental Toxicity/Teratogenicity

Species: Strain:

rat other: Wistar Crl:

Sex: male/female (WI) BR (outbred, SPF quality)

Route of administration: Exposure period:

gavage males: 2 weeks prior to mating, during mating and up to termination (28 days for all males) females: 2 weeks prior to mating, during mating, during gestation and at least 4 days of lactation;

104

UNEP PUBLICATIONS

Document info
Document views379
Page views395
Page last viewedTue Jan 17 07:52:03 UTC 2017
Pages113
Paragraphs4931
Words40344

Comments