6-methyl-2-oxoperhydropyrimidin-4-ylurea

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-01-10 to 2012-03-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: EPA Health Effects Test Guidelines, OPPTS 870.1000"Acute toxicity testing background", EPA 712-C-02-189 (2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

BAYERISCHES LANDESAMT FÜR GESUNDHEIT UND LEBENSMITTELSICHERHEIT, LANDESINSTITUT FÜR ARBEITSSCHUTZ UND PRODUKTSICHERHEIT, Munich, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-methyl-2-oxoperhydropyrimidin-4-ylurea

EC Number:

214-447-6

EC Name:

6-methyl-2-oxoperhydropyrimidin-4-ylurea

Cas Number:

1129-42-6

Molecular formula:

C6H12N4O2

IUPAC Name:

(6-methyl-2-oxo-1,3-diazinan-4-yl)urea

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): 6-methyl-2-oxoperhydropyrimidin-4-yl urea, Crotodur (CDU)
- Physical state: grey solid, granulate
- Analytical purity: < 100% Crotonylidendiurea (31% N) active component
- Lot/batch No.: Crotodur (32157)
- Storage condition of test material: at room temperature, separate from nitrate salt

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: WISTAR rats Crl: WI(Han)
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 167-178 g for step 1 (animals #1-3); 160-184 g for step 2 (animals #4-6)
- Fasting period before study: 16-19 h with free access to water
- Housing: in groups in IVC cages, type II H, polysulphone cages on Altromin saw fibre bedding (lot no. 110811) in an air conditioned room (full barrier)
- Diet: Altromin 1324 maintenance diet for rats and mice (lot no. 0815), ad libitum
- Water: tap water, sulfur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

physiological saline

Remarks:

0.9% NaCl (AlleMan Pharma

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: due to its non-toxic characteristics
- Lot/batch no.: 111036, expiry date: 09/2014

MAXIMUM DOSE VOLUME APPLIED: 2 mL/kg bw

DOSAGE PREPARATION
The test item was weighed into a tared plastic vial on a precision balance. The test item was ground into a fine powder and then suspended in the vehicle. Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 females per step

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 min and with special attention given during the first 4 h post-dose). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
- Frequency of weighing: on day 1 prior to administration and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred throughout the study period.

Clinical signs:

other: No clinical signs were observed throughout the study period.

Gross pathology:

No test material related gross pathologic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified