Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May - June 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: Yellow powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch number of test material: KL384
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under storage conditions: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: suspended in distilled water
- Final dilution of a dissolved solid, stock liquid or gel: 20 % concentration in distilled water

FORM AS APPLIED IN THE TEST (if different from that of starting material) : suspended in distilled water. The test substance was prepared on the day of dosing.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: approximately 4 to 7 weeks
- Weight at study initiation: males: 102.8 g (mean); females: 96.2 g (mean)
- Fasting period before study: Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
- Housing: up to 5 rats of the same sex per cage
- Diet: standard laboratory rodent diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
- Microbiological status when known : not specified
- Method of randomisation in assigning animals to test and control groups: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 56
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: not specified

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bodyweight.

Doses:

2 g/kg bodyweight

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: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. The bodyweight of each rat was recorded on Days 1 (prior to dosing), 2,3,4, 8 and 15.
- Necropsy of survivors performed: All animals were subjected to a macroscopic examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of all tissues was recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality and no signs of specific toxicity observed

Mortality:

none

Clinical signs:

- Piloerection was observed in all rats within five minutes of dosing and throughout the remainder of day 1
- Yellow discolouration of the faeces was evident for all animals on day 2 only

Body weight:

All rats achieved anticipated bodyweight gains throughout the study.

Gross pathology:

No macroscopic abnormalities were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute lethal oral dose to rats was found to be greater than 2.0 g/kg bodyweight.

Executive summary:

A group of ten fasted rats (five males and five females) was given a single dose by gavage of the test substance, formulated in distilled water, at a dose level of 2.0 g/kg bodyweight. All animals were killed and examined macroscopically on Day 15, the end of the observation period.

There were no deaths. Clinical signs of reaction to treatment were limited to piloerection, recovery was complete by Day 2. However, a yellow discolouration of the faeces was evident for all animals on Day 2 only. All rats achieved the anticipated bodyweight gains throughout the study. No abnormalities were recorded at the macroscopic examination on Day 15.

The acute lethal oral dose to rats was found to be greater than 2.0 g/kg bodyweight.