Dimethyl 2-aminoterephthalate

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

Principles of method if other than guideline:

The test item was tested ony at a dose level of 2000 mg/kg body weight. If no compound-realted mortality is produced in this limit test according to the guidelines no full study has to be carried our.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl 2-aminoterephthalate

EC Number:

226-364-2

EC Name:

Dimethyl 2-aminoterephthalate

Cas Number:

5372-81-6

Molecular formula:

C10H11NO4

IUPAC Name:

1,4-dimethyl 2-aminobenzene-1,4-dicarboxylate

Constituent 2

Reference substance name:

dimethyl-2-aminoterephthalate

IUPAC Name:

dimethyl-2-aminoterephthalate

Details on test material:

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

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, breeding colony
- Age at study initiation: male approx. 7 weeks, female approx. 8 weeks
- Weight at study initiation: male mean 170 g, female mean 174 g
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment
- Housing: in fully air-conditioned rooms in makrolon cages on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 rat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil (Oleum sesami Ph. Eur. III)

Details on oral exposure:

The test item was tested only at a dose level of 2000 mg/kg body weight.
The animals received the compound as a 20 % suspension in sesame oil, the application volume being 10 ml/kg body weight.
The test substance was administered by gavage to fasted animals.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 males and 5 females per dose

Control animals:

no

Details on study design:

The observation period following treatment lasted 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and holidays only once. During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.

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 occured

Clinical signs:

other: Squatting posture and irregular respiration were observed in male and female animals after the application of test item. Furthermore the female animals showed sunken flanks, bristling coat and stilted gait. Beside unspecifc symtoms the female animals sho

Gross pathology:

Autopsy findings:
In one female killed at the end of the observaton period the liver was reduced in size and showed an uneven surface. No macroscopically visible changes were observed in the remaining animals killed at the end of the study.

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 body weight in both male and female animals

Executive summary:

Acute oral toxicity testing of Aminoterephthalsäuredimethylester in the Wistar rat yielded a median lethal dose above 2000 mg/kg body weight in both male and female animals.

After application of 2000 mg/kg b.w. no deaths occurred.

Beside unspecific symptoms the female animals showed impairments of motility and respiration. On day two of the study the male animals were free of symptoms. The clinical signs were reversible on day four of the study in females.

Body weight development was slightly impaired in one female animal during the whole study. Body weight development of the remaining animals was not impaired.

In one female killed at the end of the observation period the liver was reduced in size and showed an uneven surface. No macroscopically visible changes were observed in the remaining animals killed at the end of the study.