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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20.09.2010 – 27.09.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Expiration: 03/2011
Storage condition of test material: at the room temperature in tightly closed container

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
male/female
Details on test animals and environmental conditions:
- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152; with certificate of good health condition
- Age at study initiation: not specified
- Weight at study initiation: 2.6 - 3.2 kg
- Housing: individually in cages without bedding in conventional animal room
- Diet: ad libitum (standard granulated diet for rabbits TM-MAK1; producer Ing.Mrkvička)
- Water: ad libitum
- Acclimation period: at least 5 days
no signs of diseases were observed at clinical check-in, in acclimatization period and before the start of experiment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 – 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 /12

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
Only animals with healthy intact skin were used.
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48, 72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 6x6 cm
- Type of wrap if used: gauze patch, foil and cellulose cotton and held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining sample was washed with water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours after patch removal

SCORING SYSTEM: see Any other information ...

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1/24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1/24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no evidence of a corrosive effect on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, 2-(3',5'-Dichloro-2'-hydroxyphenyl)-4-quinazolinone, was tested for acute dermal irritation/corrosion.
Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at the 1, 24, 48 and 72 hours after exposure.
No symptoms of irritation were observed on the skin.
No symptoms of systemic toxicity were observed in the animals during the test period.
No skin irritation was caused by 4-hour exposure to 2-(3',5'-Dichloro-2'-hydroxyphenyl)-4-quinazolinone.
Executive summary:

The test substance, 2-(3',5'-Dichloro-2'-hydroxyphenyl)-4-quinazolinone, was tested in the study for acute dermal irritation/corrosion. Rabbits (New Zealand Albino breed) were used for the test.

Test was performed according to Method B.4 - Acute Toxicity: Dermal Irritation/Corrosion, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.

Three rabbits were exposed to 0.5 g of test substance, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and observations were made at 1, 24, 48 and 72 hours after exposure.

At first the test substance was applied on the skin of one rabbit (test animal No. 1).

Rabbit No. 1 was investigated 3 minutes, 1 hour and 4 hours after application of the test substance.

No symptoms of irritation were observed on the skin.

In confirmatory test, two others rabbits (rabbit No. 2 and No. 3) were used with 4-hour exposition period. No evidence of a corrosive effect or symptoms of irritation were observed on the skin.

No skin irritation was caused by 4-hour exposure to 2-(3',5'-Dichloro-2'-hydroxyphenyl)-4-quinazolinone. No other signs of intoxication were observed.