4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute Dermal 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:

other: not specified

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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute for Industrial Research & Toxicology, Ghaziabad
- Females (if applicable) nulliparous and non-pregnant: No
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 200±20g
- Fasting period before study: No data
- Housing:Groups of 2 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): Fresh and clean water filered through 'Aqua Guard on line water filter', was kept in glass bottles, ad libitum
- Acclimation period: The healthy Wistar albino rats selected for study accliatized to standard laboratory condition for period of one week under close veterinary supervision.

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

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: back skin of total body surface area
- % coverage: 10%
- Type of wrap if used: The test compound held in contact with an impervious dressing secured in place with an adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the site of application was cleaned with lukewarm water wiping the test compound.
- Time after start of exposure: 24 Hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

Total = 20
Group I - 2000 mg/kg - 10 (5 male and Female)
Group II - 2000 mg/kg - 10 (5 male and Female)

Control animals:

not specified

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 30 minutes time interval for first 6 hous on the day of test compund and therafter twice a day for 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: The treated animals were closely observed for clinical signs of in toxication, 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 with the purpose of recording any symptoms of ill-health 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed

Mortality:

No mortality was observed at 2000 mg/kg bw

Clinical signs:

other: Animals did not produce any clinical signs of intoxication throughout the period of observation.

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	Animal ID	Day 0	Day 7	% Gain/loss	Day 14	% Gain/loss
Group-I 2000 mg/kg b. wt	201303-1	203.5	208.7	2.56	215.5	5.90
	201303-2	202.6	209.3	3.30	215.8	6.51
	201303-3	201.8	207.9	3.02	214.0	6.05
	201303-4	204.2	210.4	3.04	217.2	8.13
	201303-5	201.5	209.6	4.01	217.9	8.13
	201303-6	201.6	208.3	3.32	216.8	7.54
	201303-7	200.9	207.5	3.28	213.3	6.17
	201303-8	200.2	207.1	3.45	216.5	8.14
	201303-9	199.5	206.3	3.40	210.2	5.36
	201303-10	201.7	209.6	3.92	217.7	7.93
Group-III 2000 mg/kg b. wt	201303-11	199.8	207.3	3.75	214.3	7.25
	201303-12	201.5	208.8	3.62	213.1	5.75
	201303-13	198.8	206.5	3.87	214.6	7.95
	201303-14	200	206.6	3.30	213.9	6.95
	201303-15	203.5	209.2	2.80	216.4	6.34
	201303-16	203.2	211.4	4.03	217.3	6.93
	201303-17	201.3	208.4	3.52	216.7	7.65
	201303-18	202.3	210.1	3.36	216.2	7.37
	201303-19	200	206.6	3.30	214.2	7.10
	201303-20	204.1	210.6	3.19	217.5	6.57

TABLE – 3

CLINICAL SIGNS AND MORTALITY

Group: I Limit Test Dose: 2000 mg/kg body weight                                                                                        

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	0/10	0
Clinical Signs - Local	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Redness	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pain	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Swelling	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Systemic signs	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 

-  = Observed after 24 hrs

0   =   No clinical sign (Normal)

+            =    Mild

++           =   Moderate

+++         =   High

 ++++     =   Severe

TABLE – 3 Contd….

CLINICAL SIGNS AND MORTALITY

Group: II Confirmatory Test Dose: 2000 mg/kg body weight

                                                                                                                                 

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	0/10	0
Clinical Signs - Local	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Redness	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pain	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Swelling	-	-	-	-	-	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Systemic signs	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

 

- = Observed after 24 hrs

0         =   No clinical sign (Normal)

+            =    Mild

++           =   Moderate

+++         =   High

 ++++     =   Severe

TABLE – 4

SUMMARY OF NECROPSY FINDINGS

S. No.	Fate	Wistar albino rats
		Dose (mg/kg b. wt)
		2000 (Limit Test)	2000 (Confirmatory Test)
1	Terminal sacrifice	10/10	10/10
2	Found Dead	0/10	0/10
3	Abnormalities detected	0/10	0/10

TABLE - 5

INDIVIDUAL ANIMAL FATE & NECROPSY FINDINGS

Group: I (Limit Test) Dose: 2000 mg/kg bw
Animal ID	Fate	Time	Gross Findings
201303-1	TS	Day 15	NAD
201303-2	TS	Day 15	NAD
201303-3	TS	Day 15	NAD
201303-4	TS	Day 15	NAD
201303-5	TS	Day 15	NAD
201303-6	TS	Day 15	NAD
201303-7	TS	Day 15	NAD
201303-8	TS	Day 15	NAD
201303-9	TS	Day 15	NAD
201303-10	TS	Day 15	NAD
Group: I (Limit Test)Dose: 2000 mg/kg bw
201303-11	TS	Day 15	NAD
201303-12	TS	Day 15	NAD
201303-13	TS	Day 15	NAD
201303-14	TS	Day 15	NAD
201303-15	TS	Day 15	NAD
201303-16	TS	Day 15	NAD
201303-17	TS	Day 15	NAD
201303-18	TS	Day 15	NAD
201303-19	TS	Day 15	NAD
201303-20	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 dermal 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 applied by dermal route in wistar albino 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 dermal toxicity profile of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) in wistar albino rats. The study was conducted under the OECD Guideline-402 for testing of chemicals. In limit test, healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization. Approximate 10% back skin of total body surface area was prepared 24 hrs prior to application of test compound. Test drug was applied dermally at the dose of 2000 mg/kg bw for each animal. The treated animals were observed for clinical signs of intoxication. The body weight of all the animals was observed weekly on day 0 (pre treatment), 7th and 14th (post treatment). The Necropsy was performed on all at the termination of the study. After 72 hrs, a confirmatory test was conducted in same species of animals to confirm the limit test of the test compound. Rats were observed for mortality at 30 minutes time interval for first 6 hous on the day of test compund and therafter twice a day for 14 days. All the rats were observed at least twice daily with the purpose of recording any symptoms of ill-health or behavioral changes. The organ which showed gross pathological change during necropsy subjected for histopathological study. No mortality was observed at 2000 mg/kg bw. Animals did not produce any clinical signs of intoxication throughout the period of observation.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. Therefore, it was concluded that the test compoundAluminium, 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".