Yellow PE 3260

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate

Cas Number:

115811-45-5

Molecular formula:

C29H19N9O10S2.2C6H16NO3

IUPAC Name:

bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate

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: BRL Biological Research Laboratories Ltd., Wölferstr. 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: 8-10 weeks
- Weight at study initiation: females: 178-193g; males: 196-210g
- Fasting period before study: about 21h
- Housing: groups of 5 animals in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Kliba 343 rat maintainance diet ad libitum
- Water (e.g. ad libitum): Itingen community tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1996-07-24 To: 1996-08-07

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mg/kg bw

Doses:

limit dose of 2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females per dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: 4 times during day 1 and once daily during days 2-15
- Weighting: On days 1 (pre-administration), 8, and 15
- Necropsy of survivors performed: yes

Statistics:

The logit-model for LD50 determination could not be used as no deaths occured.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs of toxicity were observed during the study period.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The mean lethal dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. It can therefore be concluded that the LD50 is greater than 2000 mg/kg bw.

Executive summary:

The acute oral toxicity of the substance was determined according to OECD Guidelines for Testing of Chemicals, Section 4, Number 401 "Acute Oral Toxicity", adopted February 24, 1987 and Directive 92/69/EEC, B.1. "Acute Toxicity-Oral", July 31, 1992.

A group of five male and 5 female Wistar rats was treated with the substance at 2000 mg/kg bw by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg bw. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.

There were no deaths as a result of treatment with the test article. No clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the physiological range of variability known for rats of this strain and age. No macroscopic findings were observed at necropsy.

The mean lethal dose of the substance after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated. It can therefore be concluded that the LD50 is greater than 2000 mg/kg bw.