Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

no details to test item, some data concerning animals (breeder, acclimatization period) and enviromental conditions (humidity and air changes 7h) are missing, frequency of observation not given, no details to autopsy result or any individual data

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

EC Number:

276-057-2

EC Name:

Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

Cas Number:

71832-85-4

Molecular formula:

C16H13ClN4O7S.1/2Ca

IUPAC Name:

calcium bis[4-({1-[(2-chlorophenyl)carbamoyl]-2-oxopropyl}diazenyl)-3-nitrobenzenesulfonate]

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: 5-6 weeks
- Weight at study initiation: 113 g male and 131 g female
- Fasting period before study: 18h
- Housing: singly
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: /

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): /
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2 % aqueous solution

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- Amount of vehicle (if gavage): 20 ml/kg bw

MAXIMUM DOSE APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 per sex and dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and autopsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no

Clinical signs:

other: no

Gross pathology:

no findings

Any other information on results incl. tables

No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) in rats is greater than 5 g/kg bw. Therefore, no indication for acute toxicity is indicated.

Executive summary:

The test substance was tested for its acute toxicity potential in the standard acute test method, similar to OECD 401. Five male and female Sprague-Dawley rats were individually housed. The test substance was administered in a carboxymethyl cellulose vehicle as a limit dose of 5000 mg/kg bw. Animals were observed for clinical signs and an autopsy was performed at the end of the 14 day observation period. There were no clinical symptoms observed and no animal died during the study. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. The acute oral median lethal dose (LD50) was greater than 5000 mg/kg body weight and the test substance is not considered acute toxic in rats.