4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic 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 of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. – 15790-07-5) in Wistar Albino Rats.

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

EC Number:

239-888-1

EC Name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Cas Number:

15790-07-5

Molecular formula:

C16H9AlN2O7S2

IUPAC Name:

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex

Details on test material:

Name - Aluminium, 6-hydroxy-5-{(4-sulfophenyl) azo}-2-Naphthalenesulfonic acid complex
InChI - 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)
26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
Smiles - c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
Mol. formula: C16H9AlN2O7S2
Molecular Weight - 432.368 g/mole

Specific details on test material used for the study:

Name - Aluminium, 6-hydroxy-5-{(4-sulfophenyl) azo}-2-Naphthalenesulfonic acid complex
InChI - 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)
26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
Smiles - c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
Mol. formula: C16H9AlN2O7S2
Molecular Weight - 432.368 g/mole
Characteristics : Orange yellow powder
Source: Unique Chemicals & Allied Products

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute for Industrial Research & Toxicology
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 9 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: Fasted overnight prior to treatment
- Housing:Groups of three animals of similar sex in polypropylene cages with stainless steel grill top, facilities for food and water bottle, and bedding of clean paddy husk.
- Diet (e.g. ad libitum): Pelleted feed
- Water (e.g. ad libitum):Aqua Guard filter water was kept in PVC bottles, ad libitum
- Acclimation period:One week in experimental room after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature between 22-25°C
- Humidity (%): relative humidity 40-60%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.

IN-LIFE DATES: From:18/03/2013 To:28/04/2013

Administration / exposure

Route of administration:

other: oral cannula

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2000 mg/ml
- Amount of vehicle (if gavage):10 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:2000 mg/kg

Doses:

2000 mg/kg

No. of animals per sex per dose:

Three (3 females)/step

Control animals:

yes

Remarks:

Group I: Dist. water, 10ml/kg body wt.

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment).Rats were observed for mortality at the time interval of 30 minutes, 1hr, 2hr, 4 hr, and 6hr time interval on the day of test compound administration and thereafter twice a day for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: 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 organ which showed gross pathological change during necropsy subjected for histopathological study.

Statistics:

No data

Results and discussion

Preliminary study:

No data

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality observed

Effect levels 2

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at 2000 mg/kg body weight

Clinical signs:

other: At the dose level of 2000 mg/kg body weight did not produce any clinical signs of toxicity during the entire observation period.

Gross pathology:

No significant gross pathological changes related to compound toxicity were observed.

Other findings:

Skin and hair coat was observed wet.

Any other information on results incl. tables

TABLE – 2

SUMMARY OF BODY WEIGHT (GM)

Group	Day 0	Day 7	% Gain/loss	Day 14	% Gain/loss
Group-I distilled water 10ml/kg	201.4	208.9	3.72	214.4	6.45
Group-II 2000 mg/kg b. wt	203.7	210.2	3.19	216.9	6.48
Group-III 2000 mg/kg b. wt	200.2	209.2	4.49	215.7	7.74

TABLE – 3

CLINICAL SIGNS AND MORTALITY

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

                                                                                                  

                 FEMALE RATS

Parameters	Incidence of clinical signs observed after dosing																			Mortality
	Day 0					DAY
	Min	Hour
	30	1	2	4	6	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	0	0	0	0/3
Clinical Signs	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

0         =   No clinical sign (Normal)

+         =   Clinical Sign

TABLE – 3 (Contd.)

CLINICAL SIGNS AND MORTALITY

Group: II Dose: 2000 mg/kg b. wt.

 

FEMALE RATS

Parameters	Incidence of clinical signs observed after dosing																			Mortality
	Day 0					DAY
	Min	Hour
	30	1	2	4	6	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	0	0	0	0/3
Clinical Signs	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 0           =   Normal

+            =    Mild

++           =   Moderate

+++         =   High

 ++++     =   Severe

TABLE – 3 (Contd.)

CLINICAL SIGNS AND MORTALITY

Group: III   Dose: 2000 mg/kg b.wt

                                            

FEMALE RATS

Parameters	Incidence of clinical signs observed after dosing																			Mortality
	Day 0					DAY
	Min	Hour
	30	1	2	4	6	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	0	0	0	0/3
Clinical Signs	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

0            =   Normal

+            =    Mild

++           =   Moderate

+++         =   High

 ++++     =   Severe

TABLE – 4

SUMMARY OF NECROPSY FINDINGS

S. No.	Fate	Wistar albino rats
		Dose (mg/kg b. wt)
		Distilled water (10 ml/kg)	2000	2000
1	Terminal sacrifice	3/3	3/3	3/3
2	Found Dead	0/3	0/3	0/3
3	Abnormalities detected	NAD	NAD	NAD

NAD - No abnormality recorded

TABLE - 5

INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS

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

                                                                                                                    

FEMALE RATS

 

Animal ID	Fate	Time	Gross Findings
201303-1	TS	Day 15	NAD
201303-2	TS	Day 15	NAD
201303-3	TS	Day 15	NAD

 

Day 0 is the day of dose administration.

TS- Terminal Sacrifice

NAD- No abnormality Detected

 

TABLE – 5 Contd……..

INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS

Group: II  Dose: 2000 mg/kg b.wt.                  

FEMALE RATS 

Animal ID	Fate	Time	Gross Findings
201303-4	TS	Day 15	NAD
201303-5	TS	Day 15	NAD
201303-6	TS	Day 15	NAD

Day 0 is the day of dose administration.

TS- Terminal Sacrifice

NAD- No abnormality Detected

FD- Found Dead

TABLE – 5 contd……….

INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS

Group: III Dose: 2000 mg/kg b.wt.      

                                                     

                                                           FEMALE RATS  

Animal ID	Fate	Time	Gross Findings
201303-7	TS	Day 15	NAD
201303-8	TS	Day 15	NAD
201303-9	TS	Day 15	NAD

 

Day 0 is the day of dose administration.

TS- Terminal Sacrifice

NAD- No abnormality Detected

FD- Found Dead

 

 

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute oral LD50 of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when administered via oral route in wistar albino female rats falls into the “Category Unclassified" according to criteria of CLP.

Executive summary:

The study now reported was designed and conducted to determine the acute oral toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino female rats. The study was conducted under the OECD Guideline-423 for testing of chemicals.The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition and divided into test compound and vehicle control group each having three animals. Initially, the test compound was mixed with distilled water and administered orally at the dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats. However; vehicle control group treated with distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first 4 hours of test compound administration. Thereafter, all the animals were observed periodically at 1 hour interval for 24 hrs and twice daily for a period of 14 days. The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality at the dose level of 2000 mg/kg body weight during the entire observation period. Animals did not produce any clinical signs of toxicity during the entire observation period. Animals showed normal gain in body weight on day 7th and 14th as compared to control group. No significant gross pathological changes related to compound toxicity were observed. Skin and hair coat was observed wet. It was concluded that the test compound Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) is non-toxic at the tested dose level 2000 mg/kg body weight. According to criteria of CLP, it comes under the “Category Unclassified".