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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report which meets basic scientific principles. The animals were tested for skin and eye irritation at the same time; only 2 animals were used, simultaneously; few details in study report.
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted in Apr 2002
Deviations:
yes
Remarks:
animals were tested for skin and eye irritation ; only 2 animals were exposed; few details in study report.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): [trade name given]
- Physical state: white crystalline powder
- Analytical purity: 100%
- Lot/batch No.: 10SC8156928-2-2

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Age at study initiation: 21 weeks
- Weight at study initiation: 3.18 - 3.20 kg (range)
- Housing: the animals were individually housed in aluminium suspended cages with stainless steel mesh in the front and floor, w450 x d550 x h350 mm (Yamato Scientific Co., Ltd., Tokyo, Japan). Cages were exchanged with washed, sterile cages every 2 weeks.
- Diet: app. 120 g/day pellet diet for rabbits, LCR-4 (Oriental Yeast Co., Ltd., Japan)
- Water: tap water via automated water supply equipment (Labo Engineering Co.Ltd., Japan.), ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 ± 20
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as the control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance was moistened with 0.4 mL of distilled water
Duration of treatment / exposure:
4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals:
2 males
Details on study design:
TEST SITE
- Area of exposure: dorsal area

REMOVAL OF TEST SUBSTANCE
- Washing (if done): absorbent cotton with water was used to wipe the application site and remove the test substance
- Time after start of exposure: 4 h

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of 2 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No erythema or edema was observed in any rabbit at any reading time point. All the scores were 0.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU