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Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
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:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Dermal toxicity of 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide (CAS No. 68427-35-0) after single dose application by dermal route in rats and an observation period of 14 days.
GLP compliance:
yes
Test type:
other: Acute dermal Toxicity
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide
EC Number:
270-393-3
EC Name:
2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide
Cas Number:
68427-35-0
Molecular formula:
C20H19N3O5S
IUPAC Name:
2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-1,3-benzoxazole-5-sulfonamide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material : 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide
- Molecular formula : C20H19N3O5S
- Molecular weight :413.452 g/mole
- Substance type: Organic
- Physical state:Powder
- Source and lot/batch No.of test material:FG/15-16/1865
Specific details on test material used for the study:
- Name of test material : 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide
- Molecular formula : C20H19N3O5S
- Molecular weight :413.452 g/mole
- Substance type: Organic
- Physical state:Powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: In-House Bred at sa-FORD, Animal Facility (CPCSEA Registration No. 1256/bc/09/CPCSEA)
- Age at study initiation: No data available
- Weight at study initiation: Male:Minimum: 240 g and Maximum: 280 g , Female:Minimum: 222 g and Maximum: 239 g
- Fasting period before study:No data available
- Housing: Animals were housed three per polycarbonate cage of size 37 [cm] x 21 [cm], height 20 [cm] and identified by toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number experimental start date, dosing date and completion date.
- Diet (e.g. ad libitum): conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No: 040316., ad libitum
- Water (e.g. ad libitum): Aqua guard filtered tap water, ad libitum
- Acclimation period:7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.80 °C - Maximum: 22.80 °C
- Humidity (%):Minimum: 47.10% - Maximum: 68.60%
- Air changes (per hr):12 hour light and 12 hour dark
- Photoperiod (hrs dark / hrs light):More than 12 changes per hour

IN-LIFE DATES: From: April 19, 2016
To:May 03, 2016

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: the fur of dorsal area of the trunk of rats was clipped by using clipper.
- % coverage: greater than 10% body surface area
- Type of wrap if used: a porous gauze dressing and non-irritating tape

Details on exposure:
VEHICLE
- Concentration in vehicle: 2000 mg/kgbw
- Amount of vehicle (if gavage): 0.2 ml
- Justification for choice of vehicle:No data available
- Lot/batch no. (if required):No data available
- Purity:No data available

MAXIMUM DOSE VOLUME APPLIED:2000 mg/kgbw
Duration of exposure:
24 hour
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5 male, 5 female
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 day observation period
- Frequency of observations and weighing: at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing) and once a day during the 14 day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Yes
Statistics:
No statistical analysis was performed since the study was terminated with limit test

Results and discussion

Preliminary study:
no data available
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 limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
Clinical signs:
No systemic signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period
No local signs of toxicity (e.g.: Abrasion, Alopecia, Erythema, Oedema, Scale Formation etc.) were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period
Body weight:
Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0
Gross pathology:
The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality
Other findings:
No data available

Any other information on results incl. tables

Individual Animal Mortality Record

       Animal No.

Sex

Days of Observation (0 to 14)

Morning Observations

Evening Observations

01

Male

No mortality and morbidity

No mortality and morbidity

02

No mortality and morbidity

No mortality and morbidity

03

No mortality and morbidity

No mortality and morbidity

04

No mortality and morbidity

No mortality and morbidity

05

No mortality and morbidity

No mortality and morbidity

06

Female

No mortality and morbidity

No mortality and morbidity

07

No mortality and morbidity

No mortality and morbidity

08

No mortality and morbidity

No mortality and morbidity

09

No mortality and morbidity

No mortality and morbidity

10

No mortality and morbidity

No mortality and morbidity

Summary of Animal Body Weight (g) and Body Weight Changes (%)

Sex

Body Weight (gram)

Body Weight Changes (%)

Day 0

Day 7

Day 14

Day 0-7

Day 0-14

Male

Mean

261.60

273.00

298.40

4.33

14.09

SD

16.68

19.20

20.03

1.35

3.60

n

5

5

5

5

5

Female

Mean

229.60

232.40

246.00

1.21

7.14

SD

7.13

8.02

8.92

0.70

1.45

n

5

5

5

5

5

Gross Necropsy Observation

Animal No.

Sex

Gross Observation

External

Internal

01

Male

No abnormality detected

No abnormality detected

02

No abnormality detected

No abnormality detected

03

No abnormality detected

No abnormality detected

04

No abnormality detected

No abnormality detected

05

No abnormality detected

No abnormality detected

06

Female

No abnormality detected

No abnormality detected

07

No abnormality detected

No abnormality detected

08

No abnormality detected

No abnormality detected

09

No abnormality detected

No abnormality detected

10

No abnormality detected

No abnormality detected

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
The LD50 value was considered to be > 2000 mg/kg bw when Wistar male and female rats were treated with 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide.
Executive summary:

In a acute dermal toxicity study, Wistar male and female rats treated with 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide in the concentration of 2000 mg/kg bw orally by gavage as per OECD 402 and observed for 14 days. No effect on survival, clinical sign and  Local Signs/Skin Reactions were observed in treated male and female rats. Gain in body weight were observed on day 7 and 14, as compared to day 0 body weight, weighed prior to dosing in 2000 mg/kg bw treated male and female rats. In addition, No external and internal gross pathological abnormalities were observed in 2000 mg/kg bw treated male and female rats. Therefore, LD50 value was > 2000 mg/kg body weight when Wistar male and female rats treated with 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide orally by gavage.

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