Tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Sept 1990 to 30 Oct 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

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))

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): FAT 40'406/A
- Lot/batch No.: Vers. Nr. Sr 6947/14
- Expiration date of the lot/batch: July 1995
- Stability: Stable
- Stability of test article dilution: at least 48 hours
- Storage: At room temperature, protected from light

Specific details on test material used for the study:

Name: FAT 40406/A
Purity: 89.3 %

SOURCE OF TEST MATERIAL
- Source and lot/batch No. of test material:
6947/14
- Expiration date of the lot/batch:
July, 1995

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
in the original container, protected from light at room temperature
- Stability under test conditions:
stable for >48 h

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Hanibm

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf.
- Age at start of treatment: males: 8 weeks, females, 10 weeks.
- Weight at start of treatment: males: 195 - 208 g, females: 168 - 177 g.
- Fasting period before study: 12-18 h.
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batches 73/90 and 74/90 rat maintenance diet ("Kliba" Klingentalmuehle AG, CH-4303 Kaiseraugst, available ad libitum.
- Water: Community water from Itingen, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw at 2000 mg/kg group

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Mortality / Viability: Four times during test day 1, and daily during days 2-15, Body Weights: Test days 1 (pre-administration), 8 and 15, Symptoms: Each animal was examined for changes in appearance and behavior four times during day 1, and daily during days 2-15.
- Necropsy of survivors performed: yes.

Statistics:

The LOGIT-Model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen throughout the observation period.

Clinical signs:

other: All animals showed diarrhea only on day 1, after treatment.

Gross pathology:

No macroscopical findings were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 40406/A is > 2000 mg/kg bw in Wistar rats.

Executive summary:

In a GLP-compliant oral toxicity study performed according to OECD guideline 401, a group of Wistar rats (5/sex) were administered the test substance (2000 mg/kg bw) by oral gavage followed by a 14-day observation period (RCC 1990). No mortality and macroscopical changes were observed. However, only diarrhoea was observed on day one of the observation period. Based on the findings of the study, the median lethal dose (LD₅₀) of FAT 40406/A is greater than 2000 mg/kg in Wistar rats.