(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

EC Number:

410-940-7

EC Name:

(S)-5-[2-(acetyloxy)propanamido]-2,4,6-triiodo-1,3-di(chloroformyl)benzene

Cas Number:

60166-91-8

Molecular formula:

C13H8Cl2I3NO5

IUPAC Name:

1-{[3,5-bis(carbonochloridoyl)-2,4,6-triiodophenyl]carbamoyl}ethyl acetate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

The Sprague Dawley rat was chosen as a rodent species since it is widely accepted by Health Authorities as an experimental model with documented susceptibility to a wide range of toxic substances.

Number and sex:
5 males + 5 females/group

Body weight (on receipt):
Males: 225 - 250 g
Females: 200 - 225 g

Age (on receipt):
about 7-9 weeks

Supplier:
harles River Italia S.p.A.
Via Indipendenza, 11
22050 - CALCO (Como)
Shipping slip No. 00485 dated Jan. 17, 1992.

Acclimation:
about one week before the start of the test. Animals were observed daily to ascertain their fitness for the study.

Housing:
5 animals/sex/cage in air-conditioned rooms.
- Temperature: 22 ° C ± 2
- Relative humidity: 55% ± 10
- Air changes: about 20/hour filtered on HEPA 99.97%.
- Light: 12 hour cycle (7 a.m. - 7 p.m.)
- Cage size: grill cages 40.5x38.5x18h cm with stainless feeder. The waste that dropped through the grill bottom on removable paper was periodically disposed of.

Animal identification:
by nicks or tippings of the outer ear. Cage card gave experiment number, dosage group and date of administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Methylcellulose (400 cps) 0.5% in water

Details on oral exposure:

Single administration

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females per seg per dose

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

None

Clinical signs:

other: Signs of toxicity related to dose levels: At this limit dose administered neither clinical signs nor modifications of body weight gain were observed in the 14 day observation period.

Gross pathology:

Effects on organs:
Autoptic examination on all animals at the end of the
observation period showed no gross modifications of the
various organs examined.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU