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Toxicological information

Acute Toxicity: dermal

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Animals did not produce any clinical signs of intoxication throughout the period of observation.
Body weight:
Animals showed normal gain in body weight on day 7th and 14th as compared to control group.
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".