Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
1994
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

Constituent 1
Chemical structure
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
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.

Categories Display