Dimethyl 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:

2000

Report date:

2000

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:

Dimethyl 2-nitroterephthalate

EC Number:

226-134-1

EC Name:

Dimethyl 2-nitroterephthalate

Cas Number:

5292-45-5

Molecular formula:

C10H9NO6

IUPAC Name:

dimethyl 2-nitroterephthalate

Details on test material:

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

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr.27, 33178 Borchen; SPF breeding colony
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: males mean 196 +/-9 grams; females mean 189 +/-9 grams
- Fasting period before study: 16 hours
- Housing: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff R/M-H (V 1534) ad libitum
- Water: tap water in plastci bottles, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod: Lighting time 12 hours daily

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% suspension
- Amount of vehicle: 10 ml/ kg bw

Doses:

2000 mg/ kg bw

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: twice every day, on weekends and public holidays only once.
- Frequency of weighing: day 1, 8, 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths during the study

Clinical signs:

other: No symptoms were observed after administration of 2000 mg/kg bw, except one male animal showed from day 6 up to end of the observation period uncoordinated gait, extreme ataxia and blood-coloured encrusted eyelid-margins. Most likely these clinical signs

Gross pathology:

The animals killed at the end of the observation period showed no macrocopically 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 (male and female rat): > 2000 mg/kg bw.

Executive summary:

Acute oral toxicity testing of Nitro-DMT according to OECD TG 401 in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals. After administration of 2000 mg/kg body weight no mortality occurred. Symptoms were not observed, except one male animal which showed from day 6 up to the end of the observation period uncoordinated gait, extreme ataxia and bloodcolored encrusted eyelid margins. Most likely these clinical signs were not caused by the substance. Development of body weight was not impaired. All animals were killed at the end of the observation period. They showed no macroscopically visible changes.