Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Principles of method if other than guideline:

Groups of four Sprague-Dawley rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered by gavage. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.

GLP compliance:

no

Remarks:

pre GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 017

IUPAC Name:

Acid Yellow 017

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: from 150 to 227 grams.
- Housing: following oral administration of the test material, the rats were housed individually in suspended, wire-mesh cages.
- Fasting period before study: 16 hours period immediately prior to oral intubation.
- Diet: standard laboratory diet, ad libitum.
- Water: ad libitum.
- Acclimation period: all animals were kept under observation for five days prior to experimental use, during which period they were checked for general physical health and suitability as test animals.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle.
The test material was administered as a 50. 0 percent (w/v) aqueous suspension.

Doses:

4600, 6800, 10200, 15400 mg/kg

No. of animals per sex per dose:

2 males and 2 females

Details on study design:

- Duration of observation period following administration: 14 days.
- Observations and weighing: initial and final body weights as well as all mortalities and/or reactions displayed were recorded.
- Necropsy of survivors performed: necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.

Statistics:

At the end of the observation period, the acute oral median lethal dose (LD50) of each test material was calculated using the techniques of Weil, Thompson, and Thompson and Weil.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

10 200 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Standard Deviation of LD50 = ± 1200 mg/kg

Mortality:

No death occurred at 4600 and 6800 mg/kg. At 10200 2 oput of 4 rats died, while at 15400 mg/kg no rat survived.

Clinical signs:

other: Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.

Gross pathology:

Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.

Any other information on results incl. tables

Mortality and Body Weight Data

Dose (mg/kg)	Animal N. and sex	Individual body weight (g)		Number Dead/Number Tested	Percent Dead
		Test day N.
		0	14
4600	1M	184	242	0/4	0
	2M	160	244
	3F	174	194
	4F	172	177
6800	5M	182	250	0/4	0
	6M	177	250
	7F	158	192
	8F	158	167
10200	9M	178	(6-22 hrs)	2/4	50
	10M	205	268
	11F	156	(6-22 hrs)
	12F	150	178
15400	13M	160	(6-22 hrs)	4/4	100
	14M	189	(6-22 hrs)
	15F	163	(6-22 hrs)
	16F	184	(6-22 hrs)

Summary of Reactions

Dose (mg/kg)	Reaction	Time of onset after dose administration	Duration of reaction
4600	Hypoactivity	1 hour	2 days
	Ruffed fur	6 - 2 2 hours	1 day
6800	Hypoactivity	1 hour	3 days
	Ruffed fur	5 hours	3 days
	Muscular weakness	5 hours	1 day
10200	Hypoactivity	1 hour	3 days
	Ruffed fur	1 hour	3 days
	Muscular weakness	3 hours	2 days
15400	Hypoactivity	1 hour	Until death
	Ruffed fur	1 hour	Until death
	Muscular weakness	1 hour	Until death
	Prostration	5 hours	Until death

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

LD50: 10200 mg/Kg bw.

Executive summary:

Method

Young albino rats of the Sprague-Dawley strain were used in order to assess the cute toxicity potential by otral route of the test item. Selected groups of four rats (two males and two females) were intubated with the sample at selected close levels, i.e. 4600, 6800, 10200, 15400 mg/kg. All doses were administered directly into the stomachs of the rats using a hypodermic syringe equipped with a ball-tipped intubating needle. Following oral administration of the test material, the rats were observed for the succeeding 14 days. Initial and final body weights as well as all mortalities and/or reactions displayed were recorded. A necropsy was conducted on any animal which died during the study as well as on all animals sacrificed at the end of the 14 days.

Results

No death occurred at 4600 and 6800 mg/kg; at 10200 mg/kg 2 out of 4 rats died, while at 15400 mg/kg no rat survived.

Hypoactivity and ruffed fur were observed at 4600 mg/kg; hypoactivity, ruffed fur and muscular weakness at the two middle doses. At the highest tested dose hypoactivity, ruffed fur, muscular weakness and prostration were observed.

Necropsy of the animals that died revealed gastroenteritis. No gross pathologic alterations were noted among the animals sacrificed at the end of the 14-day observation period.