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EC number: 429-100-6 | CAS number: 23911-56-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997-02-24 to 1997-02-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-12-29
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 429-100-6
- EC Name:
- -
- Cas Number:
- 23911-56-0
- Molecular formula:
- C11H10O2
- IUPAC Name:
- 1-(3-methyl-1-benzofuran-2-yl)ethan-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.0-2.3 kg
- Housing: The rabbits were caged individually in PPO/HIPS Noryl®) cages (floor area: 2576 cm^2) with perforated floor. The trays under the cages were cleaned 2-3 times a week.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- clipped
- Vehicle:
- other: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: 100%, 25%, 10%, 5% and 1%
VEHICLE
- Amount applied: 0.5 mL
- Concentration: Ethanol 96% and diethylphthalate (DEP) in ratio 1 : 1 (w/w) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- From the beginning of treatment until 72 hours after treatment
- Number of animals:
- 4 rabbits, each was treated with 6 different concentrations of the test item
- Details on study design:
- TEST SITE
- Area of exposure: An area of 10 x 10 cm was clipped and divided into 6 test sites. Each test site was covered with a 2.5 x 2.5 cm gauze patch.
- % coverage: Not specified
- Type of wrap: The gauze patches were secured with 2.5 cm wide adhesive tape and fixed with Scanpor tape (5 cm width). Thereafter Nobifix (6 cm width) was loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: Yes, the treated skin was cleaned with lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
The skin reactions were read 1 hour after the end of treatment. Reading was also made 24, 48 and 72 hours after termination of exposure.
SCORING SYSTEM
- Method of calculation: The scores for erythema and oedema formation for the last 3 readings at 24, 48 and 72 hours for each rabbit were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation for the individual rabbits for each test concentration. The scoring system is described under "Any other information on materials and methods, incl. tables", table 1.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Remarks on result:
- no indication of irritation
- Remarks:
- The results are given for a 100 % test concentration. Also a 25%, 10%, 5% and 1% test concentration showed a score of 0.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Remarks:
- The results are given for a 100 % test concentration. A test concentration of 25% showed an erythema score of 0.33 and 10%, 5% and 1% test concentrations showed a score of 0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not irritating to the skin.
- Executive summary:
The primary skin irritant effect of the test item was investigated in a GLP-compliant study according to the method recommended in OECD Guideline 404. The study was extended to investigate five different concentrations of the test article and a vehicle control on each animal. Four rabbits were exposed to different concentrations of the test article at six skin sites on the back. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. Under the experimental conditions described in this report, the mean score for erythema and oedema in the four rabbits used was as follows:
Test concentration
100%
25%
10%
5%
1%
Vehicle
Erythema
0.3
0
0
0
0
0
Oedema
0
0
0
0
0
0
The test item should thus not be classified as a skin irritant.
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