Calcium bis[4-[[1-[[(2-methylphenyl)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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

similarities to OECD guideline 401

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-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate]

EC Number:

235-558-6

EC Name:

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

Cas Number:

12286-66-7

Molecular formula:

C17H16N4O7S.1/2Ca

IUPAC Name:

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

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

other: CFE (RAC, SPF) strain

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: /
- Age at study initiation: /
- Weight at study initiation: 126 - 139 g
- Fasting period before study: /
- Housing: groups of 5 in macrolon cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): /
- Photoperiod (hrs dark / hrs light): 14h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % in tap water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25%
- total volume: 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10.000 mg/kg bw

Doses:

5000 and 10000 mg/kg bw

No. of animals per sex per dose:

5000 mg/kg bw : 5 per sex and dose
10000 mg/kg bw : 3 males and 2 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 8d
- Frequency of observations and weighing: /
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

no martality

Clinical signs:

other: no clinical symptoms

Other findings:

yellow stained feces

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 was established to be > 10000 mg/kg bw.

Executive summary:

To evaluate the acute oral toxicity, single doses of 5000 and 10.000 mg/kg bw of the test article in 0.5 % carboxymethyl cellulose were administrated to groups of male and female rats (CFE (RAC, SPF) strain) by oral gavage. Following dosing, the animals were observed for 8d. There were no deaths observed after treatment with the test article. Clinical signs of toxicity or changes in body weight gain were not observed. Gross necropsy was without any findings.