6-amino-5-formamido-1,3-dimethyluracil

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study report which meets basic scientific principles

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 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

fixed concentration procedure

Limit test:

yes

Test material

Test material information

Constituent 1

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
- Analytical purity: 98.5%

Test animals

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Willi Gassner Versuchstierzuchtanstalt, Sulzfeltt
- Weight at study initiation: mean 181 g (males), 182 g (females)
- Diet (e.g. ad libitum): Herilan MRH, H. Eggersmann KG, Rinteln/Weser; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

inhalation: dust

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: dust-aerosols were generated by a "Dust-Generator"
- Source and rate of air: 3000 l/h


TEST ATMOSPHERE
- Brief description of analytical method used: samples were taken by a pump (Andersen Stack Sanpler Mark III Milllpore Vakuum-DruckLuftpunpe XX 50 220 50, strömugsbegrenzende Düse 3 l/min, Millipore Probensonde, Innendurchmesser 619 mmr BASFManometer, Stoppuhr) and led through an impactor, where substance was filtered and weighed
- Samples taken from breathing zone: yes

TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 6.23 µm +/- 2.26

Analytical verification of test atmosphere concentrations:

yes

Remarks:

no data given

Duration of exposure:

4 h

Concentrations:

19.4 mg/l air (nominal concentration)
5.4 mg/l air (analytical concentration)

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: prior to exposure, on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Statistics:

Binominal test

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.4 mg/L air (analytical)

Exp. duration:

4 h

Remarks on result:

other: dust

Effect levels 2

Sex:

male/female

Dose descriptor:

LC0

Effect level:

5.4

Exp. duration:

4 h

Remarks on result:

other: dust

Mortality:

No mortality

Clinical signs:

other: No abnormalities observed

Body weight:

Prior to exposure: mean 181 g (males), 182 g (females)
Day 7: mean 228 g (males), 195 g (females)
Day 14: mean 270 g (males), 206 g (females)

Gross pathology:

No abnormalities observed

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU