Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February from 3rd to 24th, 2005

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing guidelines and performed according to GLP. Nevertheless, only the summary of the test report is available, thus many details are missing.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 17 December 2001

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-490-1

EC Name:

Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-60-1

Molecular formula:

C36H21CrN8O11S.2Na

IUPAC Name:

disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)-

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Fasted females.

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

Test material was administered orally as a suspension in distilled water.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 female rats per dose

Details on study design:

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

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: A dark brown-coloured liquid discharge from the anus was noted in five animals during the day of dosing. One animal appeared normal throughout the study and the remaining animals appeared normal one day after dosing.

Any other information on results incl. tables

Individual Clinical Observations and Mortality Data

Dose level mg/kg bw	Animal number and sex	Effects Noted After Dosing (h)				Effects Noted During Period After dosing (Days)
		1/2	1	2	4**	1**	2	3	4	5	6	7	8	9	10	11	12	13	14
2000	1-0 female	0	0	D*	D*	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	1-1 female	0	0	D*	D*	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	1-2 female	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	2-0 female	0	0	D*	D*	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	2-1 female	0	0	D*	D*	0	0	0	0	0	0	0	0	0	0	0	0	0	0
2000	2-2 female	0	0	0	D*	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0 = No signs of systemic toxicity

D* = Dark brown-coloured liquid discharge from the anus

** = Bedding stained dark brown

Individual Bodyweights and Weekly Bodyweight Changes

Dose level mg/kg bw	Animal number and sex	Bodyweight (g) at Day			Bodyweight Gain (g) During Week
		0	7	14	1	2
2000	1-0 female	196	228	236	32	8
2000	1-1 female	206	242	267	36	25
2000	1-2 female	218	256	273	38	17
2000	2-0 female	203	229	240	26	11
2000	2-1 female	205	246	262	41	16
2000	2-2 female	211	231	240	20	9

Individual Necropsy Findings

Dose level mg/kg bw	Animal number and sex	Time of Death	Macroscopic Observations
2000	1-0 female	Killed Day 14	No abnormalities detected
2000	1-1 female	Killed Day 14	No abnormalities detected
2000	1-2 female	Killed Day 14	No abnormalities detected
2000	2-0 female	Killed Day 14	No abnormalities detected
2000	2-1 female	Killed Day 14	No abnormalities detected
2000	2-2 female	Killed Day 14	No abnormalities detected

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information according to the CLP Regulation (EC 1272/2008) Criteria used for interpretation of results: EU

Conclusions:

LD50 greater than 2500 mg/kg bw.

Executive summary:

Method

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - 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. 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.

Results

There were no deaths. A dark brown-coloured liquid discharge from the anus was noted in five animals during the day of dosing. One animal appeared normal throughout the study and the remaining animals appeared normal one day after dosing.

Individual body weights and weekly bodyweight changes were normal and individual necropsy revealed no abnormalities.

Conclusion

The acute oral median lethal dose (LD50) of the test material, in the female Sprague-Dawley CD strain rat, was estimated as being greater than 2500 mg/kg bodyweight.