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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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-dimethylpyrimidine-2,4(1H,3H)-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:
no abnormality detected
Body weight:
mean body weight:
- 5000 mg/kg bw: d7: female: 208 g, male: 233 g, d13: female: 224 g, male: 268 g
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)