Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- Name: Thiazol Blau
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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./ |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
at the beginning |
at the end |
|||||
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./ |
Body weight (g) |
1 h |
24 h |
48 h |
72 h |
|
at the beginning |
at the end |
|||||
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.
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