trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-5-hydroxynaphthalene-2,7-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 14 April 1999; Experiment completion date - 07 May 1999; Study completion date - 11 May 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 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 (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-240-8

EC Name:

-

Cas Number:

212652-59-0

Molecular formula:

Hill formula: C25 H22 F N8 Na3 O13 S4 CAS formula: C25 H25 F N8 O13 S4 · 3 Na

IUPAC Name:

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

Details on test material:

- Name of test material (as cited in study report): FAT 40574/B
- Physical state: Solid
- Analytical purity: Approx 75%

Specific details on test material used for the study:

Identity: FAT 40574/B
Batch: WP 23/99
Purity: Approx 75 %
Appearance: Solid, dark-red powder
Storage: At room temperature at about 20 °C
Expiration Date: 08 February 2006

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

Age when treated: Females: 10 weeks; Males: 8 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, with target ranges for room temperature 22 ± 3 °C and relative humidity 40-70 % (values above 70 % during cleaning process possible).
Room environment was monitored continuously with hourly recordings. The room was illuminated by fluorescent light on a 12 hour light/dark cycle. Recorded music was played for approximately 8 hours during the light period.
Accommodation: Groups of three in Makrolon type-4 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz)
Diet: Pelleted standard Kliba 3433, batch no. 35/98, rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to intubation).
Water: Community tap water from Itingen, available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Bidistilled water

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 males and 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Mortality / Viability: Four times during test day 1 and once daily during days 2-15.
- Body weights: On test day 1 (pre-administration), 8 and 15.
- Clinical signs: Each animal was examined for changes in appearance and behavior four times during day 1, and once daily during days 2-15.

Statistics:

No statistical analysis was used as no deaths occurred.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: CLINICAL SIGNS: No clinical signs of toxicity were observed.

Gross pathology:

Effects on organs: No treatment-related macroscopic findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of FAT 40574/B was found to be greater than 2000 mg/kg.

Executive summary:

The purpose of this study was to assess the acute oral toxicity of FAT 40574/B when administered by single oral gavage to rats, followed by an observation period of 14 days. This study was conducted according to OECD test guideline 423 in a GLP certified laboratory. Two groups, each using three female or three male Hanlbm: WIST (SPF) rats, were treated with FAT 40574/B at 2000 mg/kg 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. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No death occurred during the study. No clinical signs were observed during the observation period. The body weight of the animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy. Based on the findings of this study, the LD50 of FAT 40574/B was found to be greater than 2000 mg/kg.