2-[(o-nitrophenyl)azo]-p-cresol

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: GLP-Guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-[(o-nitrophenyl)azo]-p-cresol

EC Number:

215-863-0

EC Name:

2-[(o-nitrophenyl)azo]-p-cresol

Cas Number:

1435-71-8

Molecular formula:

C13H11N3O3

IUPAC Name:

4-methyl-2-[(2-nitrophenyl)diazenyl]phenol

Details on test material:

- Identification: TKA 40136
- Product name: Monoazo 3113
- Physical state: Red-brownish solid
- Analytical purity: > 95%
- Lot/batch No.: Pa 369
- Expiration date of the lot/batch: November 01, 1997
- Stability under storage conditions: Stable
- Stability in vehicle (1% aq. carboxymethyl cellulose): not known
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: mean(males): 287 g; mean(females): 205 g (within +/- 20% of the sex mean)
- Fasting period before study: Food was withheld overnight prior to dosing until approximately 3-4 hours after administration of the test substance.
- Housing: Group housing of 5 animals per sex per cage
- Diet: Free access to standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (e.g. ad libitum): Free access to tap-water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% aqueous carboxymethyl cellulose

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: The vehicle was selected based on a pretest performed at Notox.


MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg


DOSAGE PREPARATION (if unusual): The formulation (w/w) was prepared immediately prior to dosing. Homogeneity was accomplished to a visually acceptable level.

Doses:

2000 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 observations and weighing: Mortality/Viability were reported twice daily, body weight on days 1 (pre-administration), 8 and 15, and clinical signs at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs of toxicity were observed in any animal.

Gross pathology:

No abnormalities were found in the animals at macroscopic post mortem examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is considered not acute toxic via oral application.