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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
(2002)
Deviations:
no
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

Constituent 1
Chemical structure
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