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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-01-27 to 1989-02-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
1987
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
1984
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
EC Number:
404-540-1
EC Name:
A mixture of isomers of: 1,1'-[(3,5(or 2,4 or 4,6 or 2,6)-dihydroxy-o(or m or p)-phenylene)bis(azo-meta-phenyleneazo{1-[3-(dimethylamino)propyl]-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl})]dipyridinium-dichloride-dihydrochloride; 1-(1-[3-(dimethylamino)propyl]-5-{3-[x-(4-{1-[3-(dimethylamino)propyl]-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo}phenylazo)-2,4(or 2,6 or 3,5 or 4,6)-dihydroxyphenylazo]phenylazo}-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium-dichloride-dihydrochloride (where x is variable)
Cas Number:
159405-95-5
Molecular formula:
C50H56Cl4N14O6
IUPAC Name:
1'-[3-(dimethylamino)propyl]-5'-(2-{3-[2-(4-{2-[3-(2-{1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1lambda5-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-2,6-dihydroxyphenyl)diazen-1-yl]phenyl}diazen-1-yl)-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1lambda5-[1,3'-bipyridin]-1-ylium 1'-[3-(dimethylamino)propyl]-5'-(2-{4-[2-(4-{2-[4-(2-{1'-[3-(dimethylamino)propyl]-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1lambda5-[1,3'-bipyridin]-1-ylium-5'-yl}diazen-1-yl)phenyl]diazen-1-yl}-2,6-dihydroxyphenyl)diazen-1-yl]phenyl}diazen-1-yl)-6'-hydroxy-4'-methyl-2'-oxo-1',2'-dihydro-1lambda5-[1,3'-bipyridin]-1-ylium tetrahydrochloride tetrachloride
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, West-Germany
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: males: 247 - 295 g, females: 175 - 186 g
- Fasting period before study: no
- Housing: housed in groups of five per sex in polycarbonate cages containing purified sawdust as bedding material
- Diet (e.g. ad libitum): ree access to standard pelleted laboratory animal diet
- Water (e.g. ad libitum): free access to tap-water.
- Acclimation period: at least 5 days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3 °C
- Humidity: 30 - 70 %
- Air changes (per hr): 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1989-01-07 To: 1989-02-15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
prepared by reverse osmosis
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: stable in water for at least 2 hours
- Lot/batch no. (if required): not applicable
- Purity: prepared by reverse osmosis

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight.

DOSAGE PREPARATION (if unusual): the formulations were prepared immediately prior to dosing. The test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added. Homogeneity of the test substance in vehicle was obtained by a homogeniser.

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
At periodic intervals on the day of dosing (day 1) and once daily thereafter. All signs of reaction to treatment were recorded with particular attention paid to changes in the skin, fur, eyes and mucous membranes, as well as to behaviour pattern, tremors, convulsion, salivations, diarrhoea, lethargy, sleep and coma. Furthermore the body weight / body weight gain was recorded.
Statistics:
no statistics applied

Results and discussion

Preliminary study:
no data
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 1
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
One male animal died on day 2 after showing lethargy, tachypnoea and diarrhoea on day 1. It is not clear whether this death was treatment-related or not. All surviving animals had diarrhoea on day 2 and dark faeces on day 3. Water intake was increased in all animals after dosing.
Body weight:
Average body weight gain males from day 1 to day 15: 33.7 %
Average body weight gain females from day 1 to day 15: 32.8 %
Gross pathology:
In the animal that died, black residual substances around nose and anus. All organs in the thoracic and abdominal cavities black/blue in colour making more detailed macroscopic examination difficult. No treatment-related macroscopic findings were observed in surviving animals.

Applicant's summary and conclusion

Interpretation of results:
other: not classified within the CLP Regulation (EC 1272/2008)
Conclusions:
The oral LD50 value of test substance in rats of both sexes was estimated to exceed 5000 mg/kg body weight.
Executive summary:

The substance was administered to rats of both sexes by oral gavage at 5000 mg/kg body weight, followed by a 15 day observation period. One male was found dead on day 2.

The oral LD50 value in rats of both sexes was estimated to exceed 5000 mg/kg body weight.

The substance is not classified for acute oral toxicity, within the CLP Regulation (EC 1272/2008).