7-acetamido-4-hydroxynaphthalene-2-sulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

Acute oral toxicity study of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in Wistar albino rats

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

EC Number:

254-879-2

EC Name:

3-acetamido-5-amino-4-hydroxybenzenesulphonic acid

Cas Number:

40306-75-0

Molecular formula:

C8H10N2O5S

IUPAC Name:

3-acetamido-5-amino-4-hydroxybenzenesulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole
- InChI: 1S/C8H10N2O5S/c1-4(11)10-7-3-5(16(13,14)15)2-6(9)8(7)12/h2-3,12H,9H2,1H3,(H,10,11)(H,13,14,15)
- Substance Type: Organic
- Physical State: Solid

Specific details on test material used for the study:

- Name of test material : 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid
- Molecular formula : C8H10N2O5S
- Molecular weight : 246.24 g/mole

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Age : 7 to 9 weeks
Sex : Female, nulliparous and non pregnant. It has been observed that females are generally more sensitive than males to toxic effects
Body weight range : 200±20g
Identification : By cage tag and corresponding colour body marking
Acclimatization : One week in experimental room after veterinary examination.
Randomization : After acclimation and veterinary examination randomly selected in groups of three females.
Nutritional conditions : Fasted overnight prior to treatment. Food was offered three hours after dosing.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-25 °C
- Humidity (%): 40-60 %
- Air changes (per hr): 10-15 air change per hour
- Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark

IN-LIFE DATES: From: 22/10/2012
To:24/11/2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0 and 2000 mg/kg bw
- Amount of vehicle (if gavage):10 ml/kg
- Justification for choice of vehicle:distilled water
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):3-acetamido-5-amino-4-hydroxybenzenesulphonic acid was dissolved in distilled water to obtain final concentration of 200 mg/lm.

Doses:

0 and 2000 mg/kg bw

No. of animals per sex per dose:

Total: 9
0 mg/kg bw: 3 female
2000 mg/kg bw: 3 female (Group II)
2000 mg/kg bw: 3 female (Group III)

Control animals:

yes

Details on study design:

The test compound was administered by oral route by using of oral cannula at the dose volume of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication, first 4 hours and every 1 hrs interval for 24 hrs after dosing and thereafter twice a day for 14 days. All the rats were observed at least twice daily to observe any clinical signs or behavioral changes. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Mortality:

Wistar albino rats treated with the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not produce any mortality throughout the period of observation.

Clinical signs:

other: The test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid did not show any clinical signs of toxicity at the tested dose level of 2000 mg/kg b.wt throughout the period of observation.

Gross pathology:

Skin and hair coat was observed wet, all external orifices were normal and no gross pathological changes were observed in treated rat.

Any other information on results incl. tables

Clinical sign and Mortality

Group I (Vehicle control)                                                                                             Dose: 10 ml/kg b.wt

Parameters	Incidence of clinical signs observed after dosing															Mortality
	Day 0		Day
	Min	Hour
	30	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Total*
Mortality (total)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/3
Clinical sign	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0 = No clinical sign (Normal)

+ = Clinical sign

 

 Clinical sign and Mortality

Group II                                                                                                            Dose: 2000 mg/kg b.wt

Parameters	Incidence of clinical signs observed after dosing															Mortality
	Day 0		Day
	Min	Hour
	30	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Total*
Mortality (total)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/3
Clinical sign	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0 = Normal

+ = Mild

++ = Moderate

+++ = High

++++ = Severe

Clinical sign and Mortality

Group III                                                                                                            Dose: 2000 mg/kg b.wt

Parameters	Incidence of clinical signs observed after dosing															Mortality
	Day 0		Day
	Min	Hour
	30	1	2	3	4	5	6	7	8	9	10	11	12	13	14	Total*
Mortality (total)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0/3
Clinical sign	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

0 = Normal

+ = Mild

++ = Moderate

+++ = High

++++ = Severe

 

 

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

From the result obtained from present investigation it can be concluded that the test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid is acutely non toxic upto the tested dose level of 2000 mg/kg b.wt in wistar albino rats when applied by oral route.
The acute oral LD50 cutoff of test compound 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid found to be more than 5000 mg/kg b.wt.

Executive summary:

In acute oral toxicity study, Wistar female rat were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in the concentration of 0 (Group I) and 2000 mg/kg bw (Group II and III) in distilled water orally by gavage. No mortality and any clinical signs of toxicity were observed in treated rat at 2000 mg/kg bw. Normal gain in body weight and Skin and hair coat was observed wet, all external orifices were normal and no gross pathological changes were observed in treated rat. Therefore, LD50 cutoff was considered to be 5000 mg/kg bw when Wistar female rat were treated with 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid orally.