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EC number: 216-706-9 | CAS number: 1646-26-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 - 15 Nov 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Five different test substance concentrations and the vehicle were tested on each animal.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- Five different test substance concentrations and the vehicle were tested on each animal.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 29 Dec 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Danish Accreditation Fund (DANAK); National Board of Health, Medicines Division, Denmark
Test material
- Reference substance name:
- Benzofuran-2-yl methyl ketone
- EC Number:
- 216-706-9
- EC Name:
- Benzofuran-2-yl methyl ketone
- Cas Number:
- 1646-26-0
- Molecular formula:
- C10H8O2
- IUPAC Name:
- benzofuran-2-yl methyl ketone
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Albino Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: MØllegaard Breeding and Research Centre, Lille Skensved, Denmark
- Weight at study initiation: 2.1 - 2.2 kg
- Housing: individually in PPO/HIPS (Noryl ®) cages (floor area: 2576 cm²) with perforated floor
- Diet: pelleted complete rabbit diet (Altromin 2123), ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5, 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:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: ethanol 96% and diethyl phthalate (DEP) 1:1
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentrations: 1, 5, 10, 25 and 100%
VEHICLE
- Amount(s) applied: 0.5 mL
- Concentration: 50% ethanol (96%) and 50% diethyl phthalate (DEP) - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals:
- 4 females
- Details on study design:
- TEST SITE
- Area of exposure: 10 x 10 cm on the dorsal area of the trunk divided into six test sites: two anterior located test sites, two centrally located test sites and two posterior located test sites
- Type of wrap if used: 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 (if done): After removal of the tape and patches, the treated skin was cleaned with lukewarm water.
- Time after start of exposure: 4 hrs
OBSERVATION TIME POINTS
reading time points: 1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: according to the method described by Draize (Draize et al., 1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance concentrations: 1, 5, 10, 25 and 100%
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance concentration: 100%
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: test substance concentrations: 1 and 5%
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: test substance concentrations: 10 and 25%
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance concentrations: 1, 5, 10, 25 and 100%
- Irritant / corrosive response data:
- Very slight erythema was observed after 24 h in one rabbit at the test sites exposed to the vehicle and the test substance at concentrations of 1, 5, 10 and 25%, and in the same rabbit after 48 h at the test sites exposed to 10% and 25% test substance concentrations. All effects were fully reversible within 72 h after dosing. No effects occurred the test site exposed to 100%.
Any other information on results incl. tables
Table 1. Results of skin irritation study.
|
|
Erythema Score at hours |
Edema Score |
|||||||||
Rabbit no. |
Test substance concentration [%] |
1 |
24 |
48 |
72 |
mean (24/48/72 h) |
1 |
24 |
48 |
72 |
mean (24/48/72 h) |
|
1 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Vehicle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
2 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Vehicle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
3 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
||
10 |
0 |
1 |
1 |
0 |
0.67 |
0 |
0 |
0 |
0 |
0 |
||
5 |
0 |
1 |
1 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
||
1 |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
||
Vehicle |
0 |
1 |
0 |
0 |
0.33 |
0 |
0 |
0 |
0 |
0 |
||
4 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Vehicle |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.
- Executive summary:
The primary skin irritant effect was investigated according to OECD Guideline 404, "Acute Dermal Irritation/Corrosion", 1992 and GLP. 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. 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 were as follows: 0.0, 0.2, 0.2, 0.1, 0.1, 0.1 (100%, 25%, 10%, 5%, 1% and vehicle) and 0.0, 0.0, 0.0, 0.0, 0.0, 0.0 (100%, 25%, 10%, 5%, 1% and vehicle), respectively.
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