Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Principles of method if other than guideline:
Single intraperitoneal injection followed by 7 day observation period.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
EC Number:
284-723-9
EC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
Cas Number:
84962-27-6
Molecular formula:
C32H20CrN10O14S2.1.5(C28H31N2O3).1.5(C11H25NO)
IUPAC Name:
Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]chromate(3-), compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine
Details on test material:
Name of the test substance used in the study report: Neozaponechtfeuerrot BL (96-3058)

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
Mean body weight:m ales 30 g, females 24.8 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Details on exposure:
Aqueous suspension with CMC
Test concentration used: 14% (G/V)
Doses:
800, 1000, 1250, 1600, 2000, 2500 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 100 mg/kg bw
Mortality:
800 mg/kg: no deaths after 8 days; 1000 mg/kg: 1/10 after 8 days; 1250 mg/kg: 7/10 after 8 days; 1600 mg/kg: 9/10 after 8 days; 2000 and 2500 mg/kg: 10/10 after 8 days
Clinical signs:
Dyspnea, urine, feces and tails red coloured
Gross pathology:
Organ colouring, intra-abdominal substance residues

Applicant's summary and conclusion