Registration Dossier

Administrative data

Description of key information

it can be concluded that the substance will not have any toxicity effect in any of the route of exposure that is oral, dermal and inhalation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats
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.
Route of administration:
oral: drinking water
Vehicle:
water
Remarks:
distilled water
Doses:
DOSE FORMULATION :
Dose preparation of the test article was done freshly, few minutes prior to dosing. Test substance CAS No. 85-73-4 was dissolved in distilled water to obtain final concentration of 200mg/ml
No. of animals per sex per dose:
Three female rats were used per step for each dose level.
Control animals:
yes
Sex:
female
Dose descriptor:
LD50
Effect level:
5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: non toxic in wistar albino rats

The acute oral toxicity study of 85-73-4 was conducted in wistar albino rats. The study was conducted with the compliance of 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.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All the Wistar albino rats which were treated with the test compound 85-73-4 observed normal without any mortality and clinical signs of toxicity. Furthermore, No clinical signs and mortality were observed in vehicle control group.
Executive summary:

Finally, it is concluded that the test compound,following the guideline OECD-423 is non toxic to wistar albino rats. According toGlobally Harmonised Classification System for Chemical Substances,it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50cutoff is 5000 mg/kg b.wt.

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
K1 level data

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Test material information:
Composition 1
Species:
rat
Strain:
Wistar
Sex:
male/female
Type of coverage:
open
Vehicle:
water
Duration of exposure:
14 days
Doses:
2000 mg/kg b.wt.
No. of animals per sex per dose:
No. of animals per dose group : 10 (5male & 5 female)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Ten healthy wistar albino rats of both sex (ranging b.wt 200±20 gm) selected for study after acclimatization. Approximate 10 percent back skin of total body surface area was prepared 24 hrs prior to application of test compound. The test compound CAS No. 85-73-4was applied dermally at the dose level of 2000 mg/kg b.wt to each animal. The treated animals were observed for clinical signs of intoxication and mortality at different time interval for a period of 14 days. The body weight of each rat was observed on day 0 (pre treatment), 7thand 14th(post treatment). The necropsy was performed on all animals which was died during the study or were sacrificed at termination of the study.

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

SUMMARY OF RESULTS

Mortality:There was no incidence of mortality recorded after administration of test compound 85-73-4 at the dose level of 2000 mg/kg b.wt.

Clinical signs:The test compound CAS No. 85-73-4did not elicit any clinical signs of toxicity during the entire observation period. No skin reaction was observed after 24thhrs. of patch removal.

Body weight:The body weight of each animal recorded on day 0, 7thand 14thshowed normal increase in weight was recorded.

Conclusion:Result obtained from present investigation can be concluded that the test compound CAS No. 85-73-4is acutely non toxic at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats when applied by dermal route.The acute dermal LD50of test compound CAS No. 85-73-4found to be more than 2000mg/kg b.wt. (> 2000 mg/kg b.wt.).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
K1 level data

Additional information

Acute Oral toxicity :

Finally, it is concluded that the test compound,following the guideline OECD-423 is non toxic to wistar albino rats. According toGlobally Harmonised Classification System for Chemical Substances,it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50cutoff is 5000 mg/kg b.wt.

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

Acute dermal toxicity :

SUMMARY OF RESULTS

Mortality:There was no incidence of mortality recorded after administration of test compound 85-73-4 at the dose level of 2000 mg/kg b.wt.

Clinical signs:The test compound CAS No. 85-73-4did not elicit any clinical signs of toxicity during the entire observation period. No skin reaction was observed after 24thhrs. of patch removal.

Body weight:The body weight of each animal recorded on day 0, 7thand 14thshowed normal increase in weight was recorded.

Conclusion:Result obtained from present investigation can be concluded that the test compound CAS No. 85-73-4is acutely non toxic at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats when applied by dermal route.The acute dermal LD50of test compound CAS No. 85-73-4found to be more than 2000mg/kg b.wt. (> 2000 mg/kg b.wt.).

Justification for selection of acute toxicity – oral endpoint

Finally, it is concluded that the test compound,following the guideline OECD-423 is non toxic to wistar albino rats. According toGlobally Harmonised Classification System for Chemical Substances,it comes under the Globally Harmonized Classification (GHC) Category-5 (>2000-5000) and LD50cutoff is 5000 mg/kg b.wt.

Justification for selection of acute toxicity – inhalation endpoint

In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of phthalylsulfathiazole is very low ( 0.00000000000000283 Pa at 25 deg C). Hence exposure to humans is unlikely given the very low vapour pressure; thereby justifying the data waiver using the exposure consideration.

Justification for selection of acute toxicity – dermal endpoint

Result obtained from present investigation can be concluded that the test compound CAS No. 85-73-4is acutely non toxic at the tested dose level of 2000 mg/kg b.wt in Wistar albino rats when applied by dermal route.The acute dermal LD50of test compound CAS No. 85-73-4found to be more than 2000mg/kg b.wt. (> 2000 mg/kg b.wt.).

Justification for classification or non-classification

All the end point study indicate that the substance will not have any toxicity effect in any of the route of exposure that is oral, dermal and inhalation.