3-nitro-p-toluic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed OECD study with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-nitro-p-toluic acid

EC Number:

202-549-3

EC Name:

3-nitro-p-toluic acid

Cas Number:

96-98-0

Molecular formula:

C8H7NO4

IUPAC Name:

4-methyl-3-nitrobenzoic acid

Details on test material:

Purity: 99.5 %

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Wistar rat I Hoe: WISKf (SPF71)
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation:males: 178 - 185 g; females: 168 - 179 g
- Fasting period before study: 16 hours
- Housing: in fully air-conditioned rooms in makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet; (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): 50+-20
- Photoperiod:12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2% potatoe starch in deionised water

Details on oral exposure:

The animals received the compound as a 20 % suspension in 2 % starch mucilage (potatoe starch in deionised water), the application volume being
10 ml/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day and weighing: day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no

Clinical signs:

other: No symptoms were observed after application of 2000 mg/kg body weight.

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the substance is greater than 2000 mg/kg bw; therefore no classification is required.

Executive summary:

Acute oral toxicity testing of Nitro-p-tolylsaure in the Wistar rat was tested according OECD guideline 401 only at a dose level of 2000 mg/kg body weight.

The animals received the compound as a 20 % suspension in 2 % starch mucilage (potatoe starch in deionised water), the application volume being 10 ml/kg body weight.

After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred.