Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

EC Number:

233-357-8

EC Name:

Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

Cas Number:

10127-27-2

Molecular formula:

C16H11CrN5O8S.Na

IUPAC Name:

sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Tif. RAI

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ciba-Geigy breeding colony, SPF-breed
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: 160 to 180 g
- Fasting period before study: during one night before starting the treatment
- Housing: Macrolon cages type 3, 5 animals per cage
- Diet: NAFA rat diet, Gossau SG, ad libitum
- Water. water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 1°C
- Humidity: ca 50 %

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 30 % suspension

Doses:

4640, 6000 and 7750 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 700 mg/kg bw

Based on:

test mat.

Mortality:

one male animal of the high dose group died within 24 h

Clinical signs:

other: within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, exophthalmus, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. The surviving animals had recovered within 7 to 8 days

Gross pathology:

No gross organ changes were seen in dead and killed animals at scheduled necropsy.

Any other information on results incl. tables

Table 1: individual results

[mg/kg bw]
			1 hour		24 hours		48 hours		7 days		14 days
	m	f	m	f	m	f	m	f	m	f	m	f
4640	5	5	0	0	0	0	0	0	0	0	0	0
6000	5	5	0	0	0	0	0	0	0	0	0	0
7750	5	5	0	0	1	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Regulation (EC) 1272/2008

Conclusions:

4640, 6000 and 7750 mg test item per kg bw were administered in male and female rats. During the 14 days observation period 1 male died, resulting in a LD50 > 7750 mg/kg bw.

Executive summary:

Male and female rats were subjected to test acute oral toxicity according to a protocol similar to OECD TG 401. The test item was administered at dose levels of 4640, 6000 and 7750 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period one male died and there were no ab normalities found in necropsy, thus leading to an LD50 > 7750 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.