6-amino-1,3-dimethyluracil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-amino-1,3-dimethyluracil

EC Number:

229-662-0

EC Name:

6-amino-1,3-dimethyluracil

Cas Number:

6642-31-5

Molecular formula:

C6H9N3O2

IUPAC Name:

6-amino-1,3-dimethyl-1,2,3,4-tetrahydropyrimidine-2,4-dione

Details on test material:

- Name of test material (as cited in study report):
1,3-Dimethyl-4-aminouracil, techn.
Lot/batch No.: 2064
- Physical state: solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Weight at study initiation: mean body weight: female: 180 g, male: 181 g (5000mg/kg)
- Fasting period before study: about 16 hours before administration
- Housing: 5 rats per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
0.5% aqueous carboxymethyl cellulose
- Concentration in vehicle: 50 g test substance per 100 ml
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium


MAXIMUM DOSE VOLUME APPLIED: 10 ml

Doses:

200mg/kg bw; 2000mg/kg bw; 5000 mg/kg bw

No. of animals per sex per dose:

5000mg/kg bw: 5 female rats, 5 male rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days (5000 mg/kg bw)
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

5000 mg/kg bw: 0/10

Clinical signs:

other: no abnormality detected

Gross pathology:

no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

Acute oral toxicity was analyzed in a study performed in large part equivalent to method described in OECD guideline 401. Five male and female Wistar rats received doses of 5000 mg/kg bw by gavage. Since no mortality was noted during the 14-day observation period, the LD50 was found to be >5000 mg/kg bw. Due to the observed LD50 in a study performed equivalent to OECD guideline, no classification according EU and GHS criteria is required according Directive 67/548/EC or EU GHS criteria (Regulation (EC) N° 1907/2006)