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EC number: 270-393-3 | CAS number: 68427-35-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: dermal
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:
- 2 016
- 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
- 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
Constituent 1
- 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
- Source and lot/batch No.of test material:FG/15-16/1865
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
- % coverage: greater than 10% body surface area
- Type of wrap if used: Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, residual test item was removed by using distilled water.
- Time after start of exposure:24-hour
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test item was applied uniformly over clipped dorsal area of rat skin.
- Concentration (if solution): Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.2 ml distilled water - Duration of exposure:
- 24-hour
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 amle, 5 femlae
- Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days (or other?): 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
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No effect on survival, Clinical Signs,Local Signs/Skin Reactions, Body Weight and gross pathology
- 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:
- other: 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 2
- 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 acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when male and female Wistar rats were treated with 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide (CAS No. 68427-35-0) by dermal application over the clipped dorsal area of rat skin.
- Executive summary:
The acute dermal toxicity profile of 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide (CAS No. 68427-35-0) in 10 male and female Wistar rats according to OECD Guideline 402 (Acute Dermal Toxicity) at the concentration of 2000 mg/kg bw. The given test chemical (100% pure) was moistened with 0.2 ml distilled water and applied by single dermal application on intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area. This porous gauze dressing was covered with a non-irritating tape. After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. The skin reactions were assessed.The animals were observed daily for mortality and clinical signs, during the acclimatization period and post dosing till the termination. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1, 14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs/Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were recorded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.No mortality was observed in any animal till the end of the experimental period.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.Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0.The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Therefore, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when male and female Wistar rats were treated with 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide (CAS No. 68427-35-0) by dermal application over the clipped dorsal area of rat skin. Thus, comparing this value with the criteria of CLP regulation, 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazole-5-sulphonamide cannot be classified for acute dermal toxicity.
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