4,6-dichloro-5-nitro-2-(propylthio)pyrimidine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine

EC Number:

700-475-0

Cas Number:

145783-14-8

Molecular formula:

C7H7Cl2N3O2S

IUPAC Name:

4,6-dichloro-5-nitro-2-(propylsulfanyl)pyrimidine

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Doses:

300 mg/kg and 2000 mg/kg

No. of animals per sex per dose:

300 mg/kg: 5 females, 0 males
2000 mg/kg: 1 female, 0 males

Control animals:

no

Details on study design:

In a sighting phase, two female rats received a single oral dose of 300 or 2000 mg/kg of UL111 and were assessed daily for the following 14 days for any signs of systemic toxicity.. From the results of the sighting phase of the study, a single fixed dose level of 300 mg/kg was selected for the main phase of the study.
In the main phase, four female rats were dosed with 300 mg/kg of UL111 and were assessed daily for the following 14 days for any signs of systemic toxicity.
The initial female dosed with 300 mg/kg was included in the main phase of the study, to give a total group size of five animals.

Results and discussion

Preliminary study:

2000 mg/kg bw: evident toxicity with mortality in 1/1 rat.
300 mg/kg/bw: signs of systemic toxicity with complete recovery by day 3 (1/1 rat)

Effect levels

Sex:

female

Dose descriptor:

discriminating dose

Effect level:

300 mg/kg bw

Remarks on result:

other: No. with evident toxicity: 0. No of deaths: 0. No of animals used: 5

Clinical signs:

other: No deaths. Signs of slight systemic toxicity were seen in all animals, with complete recovery by day 3.

Gross pathology:

No macroscopic abnormalities at examination post mortem.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The highes fixed dose of UL111 administered inthis test without causing any lethality (i.e. the discriminating dose-level), was 300 mg/kg to female rats.