(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 24, 1990 to November 7, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

February 24, 1987

Deviations:

yes

Remarks:

Due to difficulties in test substance production, the study was rescheduled and the protocol was replaced by a protocol with new dates and the test substance name changed to "Cartasol Blue PE 3562".

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate

EC Number:

407-240-9

EC Name:

(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate

Cas Number:

159604-94-1

Molecular formula:

C66H88Cu2N20O10S2.C3H5O3.C2H3O2

IUPAC Name:

7,7'-bis[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-{μ-4,4'-dihydroxy-1:2k2O4:O4'-3,3'-[3,3'-dihydroxy-1:2k2O3:O3'-biphenyl-bisazo-1:2(N3,N4-η:N3',N4'-η)]dinaphthalene-2-sulphonato(6-)}dicuprate(2-), mixed (1:1) acetic/lactic acid salts

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
- Rationale for alternative/additional species to rat (if applicable): recognised by international guidelines as the recommended test system
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: approx. 8 weeks
- Weight at study initiation:
males: 180 - 209 g
females: 150 - 158 g
- Housing: polycarbonate cages containing purified sawdust as bedding material
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before start of tretament under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial flourescent light / 12 hours dark per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg body weight
DOSAGE PREPARATION: the test substance was weighed into a glass flask on an analytical balance and the vehicle (w/w) was added.

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 male, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: days 1 (pre-administration), 8 and 15
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One male and two females died within approximately four hours of dosing.

Clinical signs:

convulsions

Body weight:

other body weight observations

Gross pathology:

Macroscopic post mortem examination of the animals that died during the study revealed the stomach and intestine contents to be blue (test substance) . Macroscopic post mortem examination of the surviving animals at termination revealed the lungs of one male to be flecked grey/green. White particles were noted in the urinary bladders of two males, however, this is commonly noted among rats of this age and strain and not considered toxicologically significant.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 (rat, m/f) > 5000 mg/kg bw

Executive summary:

The purpose of this study was to assess the toxicity of the test article when administered to rats as a single oral dose.

The study was carried out in accordance with OECD Guideline No. 401, "Acute Oral Toxicity ⁿ and EEC Directive 84/449/EEC, Part B. 1, "Acute Toxicity-oral ". The test item was administered by oral gavage, to five rats of each sex, at 5000 mg/kg body weight. Macroscopic examination was performed at the end of the experimental period.

Three animals died within 24 hours of dosing.

Lethargy, piloerection and convulsions were noted among the animals on the day of treatment.

All animals showed body weight gain over the study period.

Macroscopic post mortem examination of the animals that died during the study revealed the stomach and intestine contents to be blue (test substance) . Macroscopic post mortem examination of the surviving animals at termination revealed the lungs of one male to be flecked grey/green and the urinary bladders of two males to contain white particles.

The oral LD50 value of the test item in rats of either sex was established as exceeding 5000 mg/kg body weight.