Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)

EC Number:

280-676-3

EC Name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)

Cas Number:

83733-23-7

Molecular formula:

C29H18CrN7O11S.2Na

IUPAC Name:

disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)][2-[(2-hydroxybenzylidene)amino]-4-nitrophenolato(2-)-N2,O1,O2]chromate(2-)

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

TNO/W74

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann (Borchen)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: 150 - 200g
- Fasting period before study: 16h before up to 4h after application
- Housing: in groups of 5 in Makrolon type III cages
- Diet (e.g. ad libitum): Altromin (R) 1324 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: several days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 10%
- Photoperiod (hrs dark / hrs light): 12h/12h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

administered at a constant application volume of 30 mL/kg bw

Doses:

1000, 2000, 2500, 3100, 3500 and 5000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day of application: multiple observations; during 14 days observation: twice per working day, once on weekend and holiday; weekly weighing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Statistics:

Probit analysis

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

2 570 mg/kg bw

Based on:

test mat.

95% CL:

> 2 260 - < 2 830

Mortality:

From 2000 mg/kg bw on, death occured on day 2 (in the highests doese group from day 1) with mortality rates from 10 to 100%.

Clinical signs:

In dose 2000 to 4000 mg/kg bw: nausea, diarrhoea, abdominal position, staggering gait and poor general condition.
Signs occured from 2 hours after application to 4 days after application.

Body weight:

Slightly affected in all dose groups

Any other information on results incl. tables

	Dose [mg/kg bw]	1000	2000	2500	3100	3500	4000
Number of animals	dead	0	1	5	8	9	10
	with symptoms	0	10	10	10	10	10
	treated	10	10	10	10	10	10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 (oral, gavage) for female wistar rats was determined to be 2570 mg/kg bw under the conditions of the test. The substance is not classifiable according to CLP criteria.