pentasodium 4-hydroxy-7-[(sulfonatomethyl)amino]-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-8-[(2-sulfonato-4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2-sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May. 28, 2002 to Aug. 29, 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to EU Method B.1 tris in compliance with GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

- Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467

Test animals

Species:

rat

Strain:

other: HSD: Sprague Dawley SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 wk
- Weight at study initiation: 201± 9.2g (males); 186± 6.1 g (females)
- Fasting period before study: Yes, 16 h
- Housing: Transparent macroIon cages (type 4) on soft wood granulate in groups of 3 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light


IN-LIFE DATES: From: May. 28, 2002 To: Jun. 12, 2002

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension in sesame oil
- Amount of vehicle (if gavage): 10 mL/kg bw


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION (if unusual): Test substance was suspended in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight- Yes

Results and discussion

Preliminary study:

No

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: -

Mortality:

No mortalities occurred during the whole study

Clinical signs:

other: Red discolored urine was observed in all animals on the first day of the study and on Day 2 in the male animals. From Day 3 until the end of the study no symptoms were observed.

Gross pathology:

No gross pathology changes observed

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1 tris in compliance with GLP.

 

Following a range-finding study, a group of 10 fasted rats (three males and three females) were given a single oral dose of the test substance as a 20 % suspension in sesame oil, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. Red discolored urine was observed in all animals on the first day of the study and on Day 2 in the male animals. From Day 3 until the end of the study no symptoms were observed. Two female animals showed a reduced body weight gain in wk 2. In all other animals the development of body weight was not impaired. No abnormalities were noted at necropsy.

 

Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley CD rats.