2-Naphthalenesulfonic acid, 4-hydroxy-3-[2-[2-methoxy-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-7-[(sulfomethyl)amino]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From Mar. 22, 2005 to Apr. 06, 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

464-700-1

EC Name:

-

Cas Number:

607724-42-5

Molecular formula:

Hill formula: C28H24N5Na5O23S7 CAS formula: C28H29N5O23S7.5Na

IUPAC Name:

pentasodium 4-hydroxy-3-(2-{2-methoxy-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-8-(2-{2-sulfonato-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-7-[(sulfonatomethyl)amino]naphthalene-2-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

Reactive Red F01-0481

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Gartenstrasse 27. D-33178 Borchen
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 178.5± 8.8 g (mean)
- Fasting period before study: yes
- Housing: In transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 3 animals per cage
- Diet: ssniff® R/M-H (V 1534), ad libitum
- Water: tap water in plastic bottles, ad libitum

- Acclimation period: At least 5 d
- Animal identification: fur marking with KMnO4 and cage numbering

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C (short lasting deviations were permissible, e.g., during cleaning processes)
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From Mar. 22, 2005 to Apr. 06, 2005

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionized water

Details on oral exposure:

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

DOSAGE PREPARATION: Test substance was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer

CLASS METHOD: Acute toxic class method
- Rationale for the selection of the starting dose: The acute oral toxicity of test substance was tested only at a dose level of 2,000 mg/kg bw (limit test) according to toxicity data of related compounds. The animals received the test substance as a 20% suspension in deionized water, the administration volume was 10 mL/kg bw. As no compound-related mortality was produced in this limit test, no further dose was tested.

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Twice every day (in the morning and in the afternoon), on weekends and public holidays only once
- Necropsy of survivors performed: yes
- Other examinations performed: Mortality, body weight, clinical observations and macroscopic examinations

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: Dark red discolored feces was the only clinical sign observed in the animals at the time point of 4-8 h after the administration of the test substance: From Day 2 until the end of the study no symptoms were observed.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, the oral LD50 value for the test substance was found to be >2000 mg/kg bw.

Executive summary:

A study was conducted to assess the acute toxicity of the test substance on rats according to EU Method B.1 and OECD Guideline 423, in compliance with GLP.

The substance was tested only at a dose of 2,000 mg/kg bw (limit test). The substance was administered by gavage to fasted animals as a 20% suspension in deionized water. The administration volume was 10 mL/kg bw. The observation period following treatment lasted for 14 d. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once. During this time, the animals were weighed weekly. At the end of the observation period, the animals were sacrificed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

No mortality or adverse effect on development of body weight was observed. No clinical signs, except discoloured feces at the time point of 4-8 h after administration, were observed. The macroscopic examination after sacrifice did not reveal any adverse effects.

Hence, under the test conditions, the oral LD50 was > 2,000 mg/kg bw (Kauffmann, 2005a).