2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazo]phenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 May 2001 to 29 May 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

442-230-8

EC Name:

-

Cas Number:

321679-52-1

Molecular formula:

Hill formula: C31 H25 F N9 Na3 O12 S4 CAS formula: C31 H28 F N9 O12 S4 · 3 Na

IUPAC Name:

trisodium 7-(2-{4-[2-(4-{[4-({2-[2-(ethenesulfonyl)ethoxy]ethyl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}phenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-1,3,5-trisulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40'800/A
- Lot/batch No.: WP 2/01
- Purity: approx. 70%
- Expiry date: 14 February 2007
- Storage: at room temperature (range of 17-23°C)

Specific details on test material used for the study:

Identity: FAT 40800/A
Batch number: WP 2/01
Active ingredient: ca. 70 %
Aggregate state at room temperature: Solid / powder
Color: Dark orange
Stability of test item: Stable under storage conditions
Stability of test item in vehicle: 24 hours at room temperature
Storage conditions: At room temperature at about 20 °C, away form direct sunlight
Expiration Date: February 14, 2007

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd., Biotechnology and Animal Breeding Division, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Weight at study initiation: Males: 194.1 - 198 g, Females: 168.5 - 174.2 g
- Fasting period before study: 16-20 hours
- Housing: In groups of three per sex in Makrolon type-4 cages with wire mesh tops and standardized softwood bedding ('Lignocel' Schill AG, CH-4132, Muttenz/Switzerland).
- Diet : Pelleted standard Provimi Kliba 3433 rat maintenance diet, batch no. 07/00 (Provimi Kliba AG, CH-4303, Kaiseraugst/Switzerland) ad libitum.
- Water : Community tap-water, from Itingen ad libitum.
- Acclimation period: Under laboratory conditions, after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, music during the light period

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Treatment: The animals received a single oral dose of the test item by gavage at 2000 mg/kg body weight after being fasted for 16 to 20 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing. The application volume was 10 mL/kg body weight.
- Observations:
Mortality/Viability: Daily during acclimatization and at least once daily during days 1-15.
Body weights: On test days 1 (pre-administration), 8 and 15.
Clinical signs: Daily during acclimatization and at least four times (target times: approximately one, two, three and five hours) on test day 1 after the test item administration, depending on the occurrence of clinical signs of toxicity. At least once daily during days 2-15, depending on the occurrence of clinical signs of toxicity. All abnormalities were recorded.
- Necropsy: All surviving animals were killed at the end of the observation period by an intraperitoneal injection of NARCOREN (Rhône Mérieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 mL/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight) and discarded after macroscopic examinations were performed. No organs or tissues were retained.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were noted during the course of the study.

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute median lethal dose (LD50) of FAT 40'800/A after single oral administration to Wistar rats of both sexes, observed over a period of 14 days is >2000 mg/kg bw.

Executive summary:

In a GLP-compliant oral toxicity study, performed according to OECD guideline 423, Wistar rats (step 1: 3 females and step 2: 3 males) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Based on the observations, the acute median lethal dose (LD50) of FAT 40800/A after single oral administration to Wistar rats of both sexes, observed over a period of 14 days is >2000 mg/kg bw.