5-nitroisophthalic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Standard acute method

Principles of method if other than guideline:

Estimate of the potential acute hazard after single administration (Determination of LD50)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-nitroisophthalic acid

EC Number:

210-568-3

EC Name:

5-nitroisophthalic acid

Cas Number:

618-88-2

Molecular formula:

C8H5NO6

IUPAC Name:

5-nitroisophthalic acid

Test material form:

solid

Details on test material:

IUPAC name: 5-Nitrobenzene-1,3-dicarboxylic acid
Mol. formula: C8H5NO6
Molecular Weight: 211.128 gm/mol
Smiles: OC(=O)c1cc(cc(c1)[N+](=O)[O-])C(=O)O
InChI: InChI=1S/C8H5NO6/c10-7(11)4-1-5(8(12)13)3-6(2-4)9(14)15/h1-3H,(H,10,11)(H,12,13)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Fasting period before study: The animals were given no feed 16hrs before administrationBut water was available ad libitum
Housing: The animals were housed in fully air-conditioned rooms.
Stainless steel wire mesh cages. Type DK-III
- Weight at study initiation:Male:182 gm
Females: 177 gm
- Diet (e.g. ad libitum): KLIBA-LABORDIAET. FA. KLINGENTALMUEHLE AG
CH-4303 KAISERAUGST. SWITZERLAND
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-40°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12H/12H (6.00-18.00 hours/18.00-6.00 hours)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50(w/v)
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: The test substance was soluble in water

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

Total 10 animals
5 males
5 Females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: RECORDING OF SIGNS AND SYMPTOMS SEVERAL TIMES ON THE DAY OF ADMINISTRATION, AT LEAST ONCE EACH WORKDAY. CHECK FOR MORIBUND AND DEAD ANIMALS TWICE EACH WORKDAY AND ONCE ON HOLIDAYS.
- Necropsy of survivors performed: yes
- Clinical signs including body weight : Not specified
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
WITHDRAWAL OF FOOD 16 HOURS BEPORE SACRIFICE WITH C02; THEN NECROPSY WITH GROSS PATHOLOGICAL EXAMINATION.
NECROPSY OF ALL ANIMALS THAT DIE AS EARLY AS POSSIBLE.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed at 5000 mg/kg bw dose level

Mortality:

No mortality observed at a dose of 5000 mg/kg bw.

Clinical signs:

other: No clinical signs observed.

Gross pathology:

No abnormilities observed

Other findings:

No abnormilities observed

Any other information on results incl. tables

Table: Body weight data

	Day	Body weight (grams)
Male	Beginning of the test	182
	Day 7	225
	Day 13	282
Female	Beginning of the test	177
	Day 7	205
	Day 13	219

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The LD50 of the test chemical was observed to be >5000 mg/kg bw when administered to male and female Wistar Rats via oral gavage route.

Executive summary:

Acute oral toxicity test was conducted on rats (strain - wistar) to observe the effect of test substance. The test substance was administered as single dose of 5000 mg/kg via gavage to 5 male animals and 5 female animals. The observations were made after 14 days of the administration. Slight increase in body weight was observed after the 14 days. No abnormalities were observed in any of the test animals (male/ female) and no mortalities were detected. Hence based on the available information, the LD50 of the test chemical was observed to be >5000 mg/kg bw. Therefore the test chemical cannot be classified according to GHS classification.