Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 to 19 June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to OECD 404 and GLP guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Thiazol Blau

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Species and strain: New Zealand White rabbit
- Source: Sándor Ferenc, 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: 9 weeks old
- Weight at study initiation: 2509-2748 g
- Housing: single
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.6-21.7
- Humidity (%): 33-69
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 16 to 19 June 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
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
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: plastic wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): body temperature water
- Time after start of exposure: 4 hours


SCORING SYSTEM:
Erythema and eschar formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exp.) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1,2,3
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
At observation one hour after patch removal, very slight erythema (score 1) was found in all animals.
At 24, 48 and 72 hours after patch removal, there were no signs of skin irritation observed.
As no local or systemic clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.
The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00, 0.00, and 0.00, respectively.
Other effects:
No effects on mortality, clinical signs or body weight

Any other information on results incl. tables

SCORING OF ERYTHEMA FORMATION

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00836/ M

2748

2787

1

0

0

0

00832/ M

2509

2801

1

0

0

0

00840/ M

2582

2759

1

0

0

0

TOTAL

-

-

3

0

0

0

 

SCORING OF EDEMA FORMATION

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00836/ M

2748

2787

0

0

0

0

00832/ M

2509

2801

0

0

0

0

00840/ M

2582

2759

0

0

0

0

TOTAL

-

-

0

0

0

0

 M = male; d = day; h = hour

 


 

MEAN VALUES OF SKIN IRRITATION SCORES

(24, 48, 72 hours reading)

Animal Number

Sex

Erythema

Oedema

00836

male

0.00

0.00

00832

male

0.00

0.00

00840

male

0.00

0.00

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to Directive 2001/59/EC and Regulation (EC) No 1272/2008, Thiazol Blau does not require classification as a skin irritant.
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Thiazol Blau does not require classification as a skin irritant.
Executive summary:

An acute skin irritation study of the test itemThiazol Blauwas performed in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 404, 2002).

An amountof 0.5 g of the solid test item was applied neat to the skin of the experimental animals. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skinand an adhesive clear plastic patch was applied. The trunk was wrapped in clear semi-occlusive plastic film with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water of body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

Mortality

There was no mortality or systemic clinical change related toThiazol Blauadministration.

General Daily Examination

There was no effect of treatment on body weight.

Examination of Skin-Irritancy

At observation one hour after patch removal, very slight erythema (score 1) was found at the application site in all animals.

At 24, 48 and 72 hours after patch removal, there were no signs of skin irritation observed.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema and oedema were 0.00 at all time points.

As no systemic or local clinical signs were observed at 72 hours after patch removal, the study was terminated after the 72-hour observation.

 

According to Directive 2001/59/EC andRegulation (EC) No 1272/2008,Thiazol Blaudoes not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals,Thiazol Blaudoes not require classification as a skin irritant.