5-nitroisophthalic acid

Endpoint summary

Description of key information

The acute oral toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The LD50 value was >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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)

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.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Data is Klimish rating 1 and from study report

Additional information

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.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.