1,4-bis(p-tolylamino)anthraquinone

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:

guideline study

Justification for type of information:

data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

Determination of the acute oral toxicity of the test substance in rats over a period of 14 observation days.

GLP compliance:

no

Remarks:

pre-dates GLP-regulation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(p-tolylamino)anthraquinone

EC Number:

204-909-5

EC Name:

1,4-bis(p-tolylamino)anthraquinone

Cas Number:

128-80-3

Molecular formula:

C28H22N2O2

IUPAC Name:

1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone

Test material form:

solid

Details on test material:

- Name of test material (IUPAC name): 1,4-Bis(p-tolylamino)anthraquinone
- Common name: C.I. Solvent Green 3
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Smiles notation: c12c(c(Nc3ccc(cc3)C)ccc1Nc1ccc(cc1)C)C(=O)c1c(C2=O)cccc1
- InChl: 1S/C28H22N2O2/c1-17-7-11-19(12-8-17)29-23-15-16-24(30-20-13-9-18(2)10-14-20)26-25(23)27(31)21-5-3-4-6-22(21)28(26)32/h3-16,29-30H,1-2H3
- Substance type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Identity: 1,4-bis(p-tolylamino)anthraquinone(BAG)
OTHER SPECIFICS: Safety precautions: Routine hygienic procedure was sufficient to assure personnel health and safety.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KLEINTIERFARM MADOERIN AG.; 4414 FUELLINSDORF/SWITZERLAND
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: Males: 150-212 g; Females: 151-191 g
- Fasting period before study: Overnight
- Housing: The animals were caged in groups of five in Macrolon cages type 3 with wire mesh tops and standardized granulated soft wood bedding.
- Identification: By cage number and individual colour spots.
- Diet (e.g. ad libitum): Pelleted standard Kliba 24/343/1 rat maintenance diet,ad libitum.
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 degC
- Humidity (%): 55 +/-10 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours/day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 10-25 %
- Amount of vehicle (if gavage): 10-20 ml
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg

Doses:

Group 1: 1000 mg/kg bw
Group 2: 5000 mg/kg bw

No. of animals per sex per dose:

5 males , 5 females per group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Frequency of weighing: 1/week
- Necropsy of survivors performed: yes
- Other examinations performed:
- Mortality: Five times during the day and daily thereafter.
- Body weight: Body weights were recorded at the day of administration and days 7 and 14 after the administration.

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed

Mortality:

Mortality was not observed.

Clinical signs:

other: 1000 mg/kg: Dyspnea, curved body position, diarrhoea and ruffeld fur. 5000 mg/kg: Sedation, dyspnea, exophthalmos, curved body position, diarrhoea and ruffeld fur. All animals had recovered within 7 observation days.

Gross pathology:

No macroscopical organ changes were observed.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 value was considered to be >5000 mg//kg bw, when male and female Wistar rats were treated with the given test chemical via oral: gavage route.

Executive summary:

The acute oral toxicity study was conducted by using the given test chemical as per OECD Guideline 401 (Acute Oral Toxicity) in male and female Wistar rats at doses from 1000 and 5000 mg/kg bw.

The given test chemical was dissolved in polyethylene glycol (10-25%) and administered as 20 ml/kg via oral gavage route. Animals were observed for mortality five times during the day and daily thereafter. Body weights were recorded at the day of administration and days 7 and 14 after the administration. Necropsy of survivors was performed.

No mortality was observed at 5000 mg/kg bw in treated animals. Clinical signs were observed such as, Dyspnea, curved body position, diarrhoea and ruffeld fur at 1000 mg/kg and Sedation, dyspnea, exophthalmos, curved body position, diarrhoea and ruffeld fur at 5000 mg/kg. All animals had recovered within 7 observation days. Normal development in body weight was observed. No macroscopical organ changes were observed.

Therefore, the acute oral LD50 value was considered to be >5000 mg//kg bw, when male and female Wistar rats were treated with the given test chemical via oral: gavage route.