Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards (without detailed documentation)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Principles of method if other than guideline:
5 mice per sex per dose were administered a single dose of the test substance via intraperitoneal injection. Clinical signs were monitored and necropsy was carried out at termination or after death if an animal died during the study. Observation period was until day 7.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
EC Number:
253-256-2
EC Name:
5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid
Cas Number:
36888-99-0
Molecular formula:
C16H9N5O6
IUPAC Name:
5,5'-(1H-isoindole-1,3(2H)-diylidene)dipyrimidine-2,4,6(1H,3H,5H)-trione
Test material form:
solid
Details on test material:
- Physical state: solid
- Analytical purity: no data

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kisslegg
- Weight at study initiation (mean values): 31.0 g (males), 26.1 g (females)

ENVIRONMENTAL CONDITIONS: not reported

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(aqueous solution)
Doses:
3200 and 6400 mg/kg bw (30% in CMC solution)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations (after application): 2 h and 1, 4, 5 and 6 days
- Frequency of weighing: only before application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 6 400 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
After application: accelerated respiration, spastic gait and streching
Between 2 h and 4 days after application: hunched body posture, closed eyes and accelerated respiration
Body weight:
no data
Gross pathology:
Orange coloured substance residues in the abdomen in both dose groups.

Applicant's summary and conclusion