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EC number: 947-402-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
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:
- other: OECD 402
- Principles of method if other than guideline:
- To determine the dermal reaction profile of test chemical in Wistar rats
- GLP compliance:
- 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 (as cited in study report): 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide- Molecular formula : C20H19N3O5S- Molecular weight : 413.452 g/mol.- Smiles :n1c2cc(S(N)(=O)=O)ccc2oc1c1cc2ccc(N(CC)CC)cc2oc1=O- InChI : 1S/C20H19N3O5S/c1-3-23(4-2)13-6-5-12-9-15(20(24)28-18(12)10-13)19-22-16-11-14(29(21,25)26)7-8-17(16)27-19/h5-11H,3-4H2,1-2H3,(H2,21,25,26)- Substance type: Organic- Physical state: Solid- Analytical purity: 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Sex:Male and Female- Source: In-House Bred at sa-FORD, Animal Facility- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant- 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 (Prior to Treatment)- Housing:Three animals were housed per polycarbonate cage of size 37 [cm] x 21 [cm], height 20 [cm].- Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 32/2016- Diet (e.g. ad libitum): All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No: 040316.- Water (e.g. ad libitum): Aqua guard filtered tap water was provided ad libitum via drinking bottles. - Acclimation period:All animals were acclimatized to the test conditions for 7 days prior to test item application.- Identification: During Acclimatization, animals were marked temporary by permanent marker, on their tails. After acclimatization, the animals were marked 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.- Randomization: Animals were selected manually. No computer generated randomization program was used- Room Sanitation: The experimental room floor and work tops were swept and mopped with disinfectant solution every day. Cages and water bottle: All the cages and water bottles were changed at least twice every week. ENVIRONMENTAL CONDITIONS - Temperature (°C): Minimum: 19.80 °C ; Maximum: 22.80 °C - Humidity (%): Minimum: 47.10%; Maximum: 68.60% - Air changes (per hr): More than 12 changes per hour - Photoperiod (hrs dark / hrs light): 12 hour light and 12 hour dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- limit dose of 2000mg/kg moistened with 0.2 ml distilled water
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 5 male and 5 female rats
- Details on study design:
- TEST SITE - Area of exposure: dorsal area - % coverage: no data available - Type of wrap if used: This porous gauze dressing was covered with a non-irritating tape REMOVAL OF TEST SUBSTANCE - Washing (if done):yes - Time after start of exposure: After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water. OBSERVATION TIME POINTS(indicate if minutes, hours or days) : All animals were observed for dermal irritation and signs of toxicity at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1 14SCORING SYSTEM: - Method of calculation: no data available
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 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
- Other effects:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation 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.No systemic signs of toxicity were observed at limit dose of 2000 mg/kg body weight of test item during the experimental period.
Any other information on results incl. tables
Individual Animal Clinical Signs, Symptoms and Local Signs/Skin Reactions
Dose:2000 mg/kg body weight
Animal No. | Sex | Hour(s) - Day 0 | Day | |||||||||
1 | 2 | 3 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | ||
01 | Male | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
02 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
03 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
04 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
05 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
06 | Female | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
07 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
08 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
09 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
10 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
Animal No. | Sex | Day | ||||||
8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
01 | Male | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
02 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
03 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
04 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
05 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
06 | Female | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
07 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
08 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
09 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
10 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
Key: 1 = Normal
Individual Animal Body Weight (g) andBody Weight Changes(%)
Dose:2000 mg/ kg bodyweight
Animal No. | Sex | Dose (mg)* | Body Weight (gram) | Body Weight Change (%) | |||
Day 0 | Day 7 | Day 14 | Day 0-7 | Day 0-14 | |||
01 | Male | 480 | 240 | 250 | 269 | 4.17 | 12.08 |
02 | 546 | 273 | 291 | 322 | 6.59 | 17.95 | |
03 | 532 | 266 | 275 | 296 | 3.38 | 11.28 | |
04 | 560 | 280 | 292 | 311 | 4.29 | 11.07 | |
05 | 498 | 249 | 257 | 294 | 3.21 | 18.07 | |
06 | Female | 470 | 235 | 239 | 253 | 1.70 | 7.66 |
07 | 478 | 239 | 243 | 258 | 1.67 | 7.95 | |
08 | 444 | 222 | 226 | 241 | 1.80 | 8.56 | |
09 | 450 | 225 | 226 | 240 | 0.44 | 6.67 | |
10 | 454 | 227 | 228 | 238 | 0.44 | 4.85 | |
Key:* =Based on the day 0 body weight
Individual Animal Mortality Record
Dose:2000 mg/kg body weight
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 | |
Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
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 | |
Keys:SD= Standard deviation, n = Number of animals
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- 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.Since no dermal reactions were observed throughout the experiment,the test chemical can be considered to be not irritating to skin.
- Executive summary:
A study was designed and conducted to determine the dermal reaction profile of test chemical in Wistar rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures. Ten rats (5 male and 5 female) were used for conducting dermal irritation /corrosion study. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. The overall irritation score of the substance was obtained to be 0 and no erythema and edema (skin irritation) were observed at the end of 14 days observation period after patch removal. Hence, it was concluded that the test substance was non-Irritating to the skin of rats under the experimental conditions tested.
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