Registration Dossier
Registration Dossier
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EC number: 207-735-8 | CAS number: 491-36-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1994-01-10 to 1994-01-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quinazolin-4(1H)-one
- EC Number:
- 207-735-8
- EC Name:
- Quinazolin-4(1H)-one
- Cas Number:
- 491-36-1
- Molecular formula:
- C8H6N2O
- IUPAC Name:
- 4-Hydroxyquinazoline
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- Lot No.: Batch 9
Purity: Not specified
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler; Offenbach / Main, Frg
- Age at study initiation: young adult animals
- Weight at study initiation: 3.15-3.49 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2, no bedding in the cages; sawdust in the waste trays
- Diet (e.g. ad libitum): about 130 g per animal per day
- Water (e.g. ad libitum): about 250 mL tap water per animal per day
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light):12 h/12 h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Untreated skin sites of the same animal - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- - Weight determination: shortly before application of the test substance.
- Route of application: the test substance was applied in a single dose to the intact untreated skin. The test patch was secured in position with a semiocclusive dressing. The test substance was removed at the end of the exposure period with Lutrol(R) and Lutrol(R)/water (1:1)
- Application volume: The test patch (2 .5 cm x 2 .5 cm) was covered with a dose of 0 .5 g of the semi-solid test substance and has been moistened with aqua bidest.
- Application site: upper third of the back or flanks
- Readings: 1 h, 24 h, 48 h and 72 h after removal of the patch .
- General observations: A check was made twice each workday and once on Saturdays, Sundays and on public holidays for general observations and for any dead or moribund animals.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- No skin reaction could be observed in all animals
Any other information on results incl. tables
Animal No. |
Time after application
|
Erythema
|
Edema |
|
1 |
1 hour |
0 |
0 |
|
24 hours |
0 |
0 |
|
|
48 hours |
0 |
0 |
|
|
72 hours |
0 |
0 |
|
|
2 |
1 hour |
0 |
0 |
|
24 hours |
0 |
0 |
|
|
48 hours |
0 |
0 |
|
|
72 hours |
0 |
0 |
|
|
3 |
1 hour |
0 |
0 |
|
24 hours |
0 |
0 |
|
|
48 hours |
0 |
0 |
|
|
72 hours |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item does not give indication of an irritant property to the skin.
- Executive summary:
The potential of test item to cause acute dermal irritation or corrosion was assessed by a single topical application of 0.5 g of the test substance to the intact skin of 3 white Vienna rabbits for 4 hours under semiocclusive dressing based on OECD404.
As no skin reaction could be observed in all animals, the study was terminated 72 hours after removal of the patches.
Under the test conditions chosen and considering the described findings the test item does not give indication of an irritant property to the skin.
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