Methyl hydrogen 2-nitroterephthalate

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:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Methyl hydrogen 2-nitroterephthalate

EC Number:

252-360-5

EC Name:

Methyl hydrogen 2-nitroterephthalate

Cas Number:

35092-89-8

Molecular formula:

C9H7NO6

IUPAC Name:

4-(methoxycarbonyl)-3-nitrobenzoic acid

Details on test material:

- Name of test material (as cited in study report): Nitro-MMT

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, SPF breeding colony
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation: average: males: 178 g; females 165 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; 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
- Lighting time: 12 hours/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

application volume : 10 ml/kg body weight


VEHICLE
- Concentration in vehicle: 20% suspension in sesame oil
- Amount of vehicle (if gavage): 10 ml/kg body weight


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Symptoms were recorded twice every day, on weekends and holidays only once. Animals were weighed weekly.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured at the dose level of 2000 mg/kg bw

Clinical signs:

other: After application: decreased spontaneous activity, squatting posture, irregular respiration as well as bristing coat, stilted and uncoordinated gait. The animals were free of clinicla signs on day three of the study and thereafter

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: expert judgment

Conclusions:

LD50: > 2000 mg/kg bw

Executive summary:

Acute oral toxicity testing of Nitro-MMT in 5 male and 5 female Wistar rats according to OECD 401 (limit test) yielded a median lethal dose above 2000 mg/kg bw.

After application of 2000 mg/kg bw no deaths occured.

Beside unspecific symptoms the animals showed impaiments of motility and respiration. The animals were free of clnical signs on day three of the study and thereafter.

Development of body weight was not impaired.

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