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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no
Remarks:
pre-GLP testing
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
6-amino-5-formamido-1,3-dimethyluracil
EC Number:
231-501-4
EC Name:
6-amino-5-formamido-1,3-dimethyluracil
Cas Number:
7597-60-6
Molecular formula:
C7H10N4O3
IUPAC Name:
N-(6-amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide
Details on test material:
- Name of test material (as cited in study report): 1,3-dimethyl-4-amino-5-formylaminouracil
- Substance No. 80/205
- Physical state: solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Willi Gassner, Sulzfeld, Germany
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: mean 207 g (males), 162 g (females)
- Fasting period before study: 16 h, but water ad libitum
- Housing: 5 per cage in wire mesh cages TypP DK-III (Becker & Co., Castrop-Rauxel)
- Diet (e.g. ad libitum): Heralin MRH-HALTUNG, H. Eggersmann KG, 3260 Rinteln; ad libitum
- Water (e.g. ad libitum): VE-water on weekdays, tap-water on weekends and public holidays; ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 45 - 75
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%, 46.4%. 31.6%, 21.5%. 14.7%
- Amount of vehicle (if gavage): 10 ml/kg bw


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
Doses:
1000, 1470, 2150, 3160, 4640, 5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:prior to dosing, day 4, day 7, day 14
- 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:
No mortality
Clinical signs:
No abnormal signs noted.
Body weight:
No abnormalities noted
Gross pathology:
No abnormalities noted.

Any other information on results incl. tables

Body weights:

Dose Weight (g) on day
mg/kg bw 0 4 7 14
Males 5000 240 278 296 321
4640 200 238 261
3160 200 235 259 284
2150 200 240 262 285
1470 200 236 236 278
1000 200 240 262 278
Females 5000 160 188 197 202
4640 170 196 206 212
3160 160 197 206 207
2150 160 188 195 195
1470 160 190 197 197
1000 160 182 190 192

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information