tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 29, 1999 to July 13, 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

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

Constituent 1

Reference substance name:

-

EC Number:

432-550-6

EC Name:

-

Cas Number:

243858-01-7

Molecular formula:

Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na

IUPAC Name:

tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Reaktiv Orange F97-0318

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, 33178 Borchen, SPF breeding colony.
- Age at study initiation: 6-10 weeks
- Body weight range at treatment: Males: 192-204 g; Females: 182-192 g
- Housing: In fully air-conditioned rooms in macrolon cages (i.e., type 4) on soft wood granulate in groups of 5 animals
- Diet: Ssnif R/M-H (V 1534), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
- Animal identification: Fur marking with KMnO4 and cage numbering
- Randomization procedure: Randomization schemes 98.0691, 98.0690
- Withdrawal of food: From about 16 h before to 3-4 h after treatment

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

IN-LIFE DATES: From: To: June 29, 1999 to July 13, 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension in deionized water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

PREPARATION OF THE TEST SUBSTANCE: Test substance was suspended in the stated concentration in deionized water 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

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

Five/sex/dose

Control animals:

not specified

Details on study design:

Test procedure

- The prepared test substance was administered by gavage to fasted animals at the stated dosage. 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 killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

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 whole study.

Clinical signs:

other: Irregular respiration, diarrhea and orange discolored feces were observed after the administration of test substance.

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 study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.

Executive summary:

A study was conducted to assess the acute oral toxicity of the test substance in HSD:Sprague Dawley rats according to OECD Guideline 401 and EU Method B.1, in compliance with GLP.

 

Groups of five female and five male fasted rats received a single oral (gavage) dose of 2,000 mg/kg bw. A 20% suspension of test substance was prepared in deionized water and administered at a volume of 10 mL/kg bw.

 

No mortality occurred, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Irregular respiration, diarrhea and orange discolored feces were observed after the administration of the test substance.

 

Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.