Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 March 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Remarks:

No detail about test item was provided as purity, stability and solubility in vehicle. GLP-Compliant study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

Dated 12 May 1981

Deviations:

yes

Remarks:

No details on test item chemical analysis

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Directive 79/831 de la C.E.E. -annexe V partie B-

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate

EC Number:

224-618-7

EC Name:

Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate

Cas Number:

4430-18-6

Molecular formula:

C21H15NO6S.Na

IUPAC Name:

sodium 2-[(4-hydroxy-9,10-dioxo-9,10-dihydroanthracen-1-yl)amino]-5-methylbenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

dark blue

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2.4.4908
- Expiration date of the lot/batch: no information
- Purity test date: no information

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
No information

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: in solution at 25% in dionized water

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

OFA strain (IOPS)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Iffra Credo (France)
- Females (if applicable) nulliparous and non-pregnant: Not specified
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: male : 160 to 220g / female : 140 to 180
- Fasting period before study: 17 to 18 hours prior to dosing
- Housing:in group of two or five animals per plastic cage (37.5 x 23.5 x 16.0 cm) with sterilized sawdust litter
- Diet (e.g. ad libitum): Diet including "Souriffarat entretien" food, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: no information

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1.5 deg celsius
- Humidity (%): 55±15% relative humidity
- Air changes (per hr): 10 per hours
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

deionized water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% in solution in vehicle
- Amount of vehicle (if gavage): 75%
- Justification for choice of vehicle:no justification

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg

Doses:

Preliminary study : dose applied : 1000, 2000, 5000 mg/kg

No. of animals per sex per dose:

In preliminary study, 2 animals were used per sex per group
In main study, 5 animals per dose per group were used

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2, 4 hours and thereafter daily until the 14 day period of observation
They were weighed the day before the treatment, the day of treatment, at day 7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Preliminary study:

After treatment, at each dose level, no mortality occured for both group and animals.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

No mortality occured during experimental procedure.

Clinical signs:

other: slight piloerection with slight despondency the two first hours after treatment

Gross pathology:

no anomaly was observed

Any other information on results incl. tables

	Table 1 : Summary of the results
	Administration			Animals		Mortality
Preliminary study	Dose (mg/kg)	Volume (ml/kg)	Concentration (g/100ml)	Weight(g)	Number	1hours	2hours	4hours	Day 1	Day 2	Day 4	Day 7	Day 14	Total (%)
	1000	4	25	Male 203	2	0	0	0	0	0	0	0	0	0
				Female163	2	0	0	0	0	0	0	0	0	0
	2000	10	25	Male 206	2	0	0	0	0	0	0	0	0	0
				Female166	2	0	0	0	0	0	0	0	0	0
	5000	20	25	Male 201	2	0	0	0	0	0	0	0	0	0
				Female160	2	0	0	0	0	0	0	0	0	0
Main Study	0	/	0	Male 155	5	0	0	0	0	0	0	0	0	0
				Female149	5	0	0	0	0	0	0	0	0	0
	5000	20	25	Male 156	5	0	0	0	0	0	0	0	0	0
				Female148	5	0	0	0	0	0	0	0	0	0

 

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental condition of this study, the registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage. The registered substance is not classified as Acute Oral Hazard.

Executive summary:

The GLP-compliant study aims the potential acute toxicity of the test item Acid Violet 43 on Sprague Dawley rats by oral routes (gavage). This study followed Standard Guideline 401 (dated 12 May 1981) and did not provided details test item (no analysis was performed: purity, stability, solubility were not reported).

The registered substance was administered orally on male and female rats (2 for preliminary study and 5 for the main study per sex) per dose group (gavage) at 1000, 2000 and 5000 mg/kg bw in preliminary study and 0 and 5000 mg/kg bw were used for the main study (limit test). The Acid Violet 43 was in suspension in deionized water.

Under the experimental condition of this study, the registered substance induced no mortality at each dose level. The Lethal Dose 50 value was defined as greater than 5000 mg/kg bw on rats by oral gavage. The registered substance is not classified as Acute Oral Hazard according CLP regulation.