Trisodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 20th, 2001 to 29th January, 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guidelines. Some details about testing procedures and test conditions are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 22 March 1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

not specified

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Acid Violet 090

IUPAC Name:

Acid Violet 090

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley Crl:CD (SD) IGS BR rat (SPL Standard Test Method 512.08).
Fasted before treatment.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

The test material was administered orally as a suspension in distilled water.

Doses:

2000 mg/kg bodyweight

No. of animals per sex per dose:

Three fasted females followed by a group of three fasted males.

Details on study design:

Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted.

Gross pathology:

No abnormalities detected.

Any other information on results incl. tables

Individual Bodyweights and weekly Bodyweight changes

Animal Number and Sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
	0	7	14	1	2
1-0 Female	218	250	265	32	15
1-1 Female	241	275	302	34	27
1-2 Female	212	230	235	18	5
2-0 Male	239	312	363	73	51
2-1 Male	224	301	350	77	49
2-2 Male	221	291	344	70	53

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

LD50 rat > 2000 mg/kg bw

Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley. The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity (Oral - Acute Toxic Class Method).

A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths. Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities.

Conclusion

LD50 rat > 2000 mg/kg bw