Alkali salt of (sulfonato oxyethane sulfonyl) arylamino triazinylamino sulfonato (sulfonato arylazo) aryl sulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 16, 2006 to May 31, 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 423, EPA OPPTS 870.1100 and EU Method B.1tris, in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class 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): Reaktiv Rot F99-0078

Test animals

Species:

rat

Strain:

other: CRL:(WI) BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles river (Europe) laboratories inc. Toxi coop Ltd. 1103 Budapest, Cserkesz u. 90.
- Date of receipt: April 26, 2006
- Age at study initiation: Young, adult rats, 8-12 weeks old
- Body weight range at treatment: 190 g to 208 g
- Hygienic level at arrival: SPF
- Sex: Female, nulliparous and non-pregnant.
- Housing: Type II polypropylene/polycarbonate, 3 animals / cage
- Bedding: Laboratory bedding
- Diet: Ssnif SM R/M-Z+H complete diet for rats and mice, ad libitum
- Water: Tap water from municipal supply from 500 mL bottle, ad libitum
- Animal health: Only healthy animals were used for the test. The veterinarian certified healthy status.
- Acclimation period: 20 and 21d
- Animal identification: Numbers on the tail written with a marker pen. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle
- Ventilation: 8-12 air exchanges/h by central air-condition system

IN-LIFE DATES: From: To: May 16, 2006 to May 31, 2006

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Batch No: 2364-1005
- Expiry date: October 31, 2006
- Storage: At room temperature

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

PREPARATION OF THE TEST SUBSTANCE: For treatment the test substance was applied in a concentration of 200 mg/mL in Distilled water. Formulations were prepared just before the administration and stirred with a magnetic stirrer up to end of the treatment.

Justification of the dose:

Starting dose was selected on the basis of available data of similar compounds. The LD50 value was expected to be above 2,000 mg/kg bw. A limit test was performed at 2,000 mg/kg bw dose.

Three female animals were treated with a dose level of 2,000 mg/kg bw of test substance in the first step. All animals survived; so three further animals were dosed at 2,000 mg/kg bw dose level next day, as the second step. No mortality occurred in either step, therefore the test was finished meeting the stopping criteria of guidelines.

Doses:

2,000 mg/kg bw

No. of animals per sex per dose:

3 females/group

Control animals:

not specified

Details on study design:

Procedure

-A single oral administration - followed by a 14 d observation period - was performed by gavage.
-On the day before each treatment the animals were fasted. The food but not water was withheld during an overnight period.
-Animals were weighed just before the treatment. The test substance was administered by oral gavage in the morning hours. The food was given back 3 h after the treatment. A constant treatment volume of 10 mL/kg bw was applied.

OBSERVATIONS

Clinical Observations

Careful clinical observation was made 15 and 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day for 14 d thereafter.
Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern as well. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.

Body Weight Measurement

The body weight was recorded on Day 0 (shortly before the treatment), then on Days 7 and 14 with a precision of 1g.

NECROPSY

Gross necropsy was performed in each experimental animal terminally. Animals were sacrificed by exsanguination under pentobarbital anaesthesia. After the examination of the external appearance the cranial, thoracic and the abdominal cavities were opened, the organs and the tissues were observed. Abnormalities were recorded on post mortem data sheets.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Test substance caused no mortality in female CRL:(WI) BR rats after a single oral (by gavage) administration of 2,000 mg/kg bw.

Clinical signs:

other: No animals showed clinical symptom on the day of the treatment and the following 14 d observation period in either groups. The physical condition and behaviour of animals were considered normal during the whole experiment.

Gross pathology:

No macroscopic alterations related to the toxic effect of test substance were found at necropsy. The pinprick-sized haemorrhages (3/3 and 3/3) observed in the lungs were due to the termination procedures and exsanguination. Hydrometra due to the sexual cycle of animals is a common observation in experimental rats (0/3, 2/3).

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

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 female CRL:(WI) BR rats according to OECD Guideline 423, EPA OPPTS 870.1100 and EU Method B.1tris, in compliance with GLP.

Groups of three female rats received a single oral (gavage) dose of 2,000 mg/kg bw in a first and second step respectively. A concentration of 200 mg/mL of test substance was prepared with distilled water and administered by gavage at a volume of 10 mL/kg bw.

 

No mortality occurred, no clinical symptoms were found, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy.

 

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