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Acute Toxicity: oral

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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:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Principles of method if other than guideline:
Acute Oral Toxicity of test chemical in Wistar Albino Rats.
GLP compliance:
not specified
Test type:
acute toxic class method
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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed at 2000 mg/kg body weight
Clinical signs:
At the dose level of 2000 mg/kg body weight did not produce any clinical signs of toxicity during the entire observation period.
Body weight:
At the dose level of 2000 mg/kg body weight 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

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 test chemical was considered to be >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in wistar albino female rats falls into the “Category Not classified" according to criteria of CLP.
Executive summary:

The acute oral toxicity study was designed and conducted for test chemical in wistar albino female rats according to the OECD Guideline-423. 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 is non-toxic at the tested dose level 2000 mg/kg body weight. According to criteria of CLP, it comes under the “Category Not classified".