6-Amino-5-chloro-2-cyclopyrimidine-4-carboxylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 March - 7 June 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

Adopted: 2001

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid

EC Number:

617-769-9

Cas Number:

858956-08-8

Molecular formula:

C8H8ClN3O2

IUPAC Name:

6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina, USA
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 227.1, 231.8 and 251.0 g
- Fasting period before study: approximately 16-18 h
- Housing: individually in stainless steel, wire-mesh cages suspended above cage boards
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: water (deionized)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: according to EPA OPPTS 870.1100

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3 (The rats were dosed one at a time at a minimum of 48 h intervals.)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation for mortality and signs of illness, injury, or abnormal behavior, clinical signs were observed at the beginning of fasting, before dosing (test day 0), once during the first 30 min after dosing and 2 more times on the day of dosing, and once daily thereafter body weight was determined on Day -1, 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed.

Clinical signs:

other: One rat exhibites diarrhea on the day after dosing. No clinical signs of toxicity were observed in the remaining two rats.

Gross pathology:

Animals sacrificed at the end of the post-treatment observation period showed no evidence of gross lesions.

Any other information on results incl. tables

 Table 1. Table for acute oral toxicity.

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Females
5000	0/1/3	Day 1 postdosing	---	0
LD50> 5000 mg/kg bw
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used

 

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

In this acute oral toxicity study in female rats a LD50 value of > 5000 mg/kg bw was determined.