2,5-dianilinoterephthalic acid

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:

1989

Report date:

1989

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:

2,5-dianilinoterephthalic acid

EC Number:

233-302-8

EC Name:

2,5-dianilinoterephthalic acid

Cas Number:

10109-95-2

Molecular formula:

C20H16N2O4

IUPAC Name:

2,5-bis(phenylamino)benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Anilosäure, Dianiloterephthalsäure, 2,5-Dianiloterephthalsäure

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, breeding colony
- Age at study initiation: male ca 7 weeks, femala ca. 8 weeks
- Weight at study initiation: male 187 g - 193 g, female 173 g - 184 g
- Fasting period before study: approximately 16 hours before treatment until 3-4 h post treatment
- Housing: in groups of five in Makrolon R cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil (Ph. Eur. III)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Purity: Oleum Sesami Ph. Eur. III

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: 15 days starting with treatment day 1
- Frequency of observations and weighing:
mortality/viability: twice daily during test days 1-15.
clinical signs: twice daily during test days 1-15
body weights: on days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

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

Clinical signs:

other: no clinical signs

Gross pathology:

No abnormal macroscopic findings at scheduled necropsy.

Other findings:

no other findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

LD50, male: >2000 mg/kg bw
LD50, female: >2000 mg/kg bw

Executive summary:

The test substance did not cause any mortality or clinical signs or abnormal necropsy findings after single oral gavage administration to male and female rats at 2000 mg/kg bw in an OECD guideline and GLP compliant study. The LD50 (male/female rat) was above 2000 mg/kg body weight.