2,5-bis(p-toluidino)terephthalic 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: Guideline study (OECD TG 401)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

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-bis(p-toluidino)terephthalic acid

EC Number:

233-651-6

EC Name:

2,5-bis(p-toluidino)terephthalic acid

Cas Number:

10291-28-8

Molecular formula:

C22H20N2O4

IUPAC Name:

2,5-bis[(4-methylphenyl)amino]benzene-1,4-dicarboxylic acid

Details on test material:

- Name of test material (as cited in study report): Toluidinosäure gemahlen
- Substance type: brown particulates
- Storage condition of test material: in the dark at approx. 22°C in a fume cupboard

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding colony
- Age at study initiation: males: approx. 7 weeks; females: approx. 6 weeks
- Weight at study initiation: males mean: 149 g; females mean: 135 g
- Fasting period before study: 16 h
- Housing: in macrolon cages (type 4), in groups of five
- Diet: Altromin 1324 (Altromin-GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at elast 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: starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% (w/v) in suspension

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

Doses:

limit dose: 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animals died within the observation period

Mortality:

- no deaths occured

Clinical signs:

other: - no clinical signs observed

Gross pathology:

- 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:

Single application of 5000 mg test item(Toluidinsäure) per kg bw did not cause lethality in male and female Wistar-rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw.

Executive summary:

Male and female Wistar-rats were subjected to test acute oral toxicity. The test item (Toluidinsäure) was administered by gavage at the limit dose of 5000 mg/kg bw. No animals died under these conditions within the 14 days observation period, thus leading to a LD > 5000 mg/kg bw.