Registration Dossier

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:
2009-04-06 to 2009-08-31
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Orient Bio, Ltd, 142- Sangdaewon-Dong, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do, Korea.
- Age at study initiation: Approx. 2 months
- Weight at study initiation: 2160 g to 2233 g
- Housing: Individually in steel cages, (590 mm width × 460 mm length × 360 mm height)
- Diet: Ad libitum, Purina
- Water: Ad libitum, tap water
- Acclimation period: 8 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C ± 3 °C
- Humidity 55 % ± 10 %
- Air changes: 10~20 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

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
- Volume applied: 0.5 mL
Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
3 male
Details on study design:
TEST SITE
- Area of exposure: The left and right sites (2.5 cm × 2.5 cm) from central backbone were assigned for control and test item treatment resepctively.
- Type of wrap if used: Covered with gauze and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Both the test and control sites were washed gently with distilled water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Primary Irritation Index of Draize. Erythema and Eschar and Oedema measured.

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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Individual observation of skin reaction at 1, 24, 48 and 72 h after the patch removal showed no formation of erythema, eschar and oedema. Therefore the primary irritation index of the test item was calculated to be 0.
Other effects:
There were neither dead animals nor detectable clinical signs in all test animals which could be considered to be due to the test item application. The bodyweights of two animals measured at 24 h were lower than measured at 0 h. All animals showed normal body weight gain at 72 h.

Any other information on results incl. tables

Results of skin reaction

Change

Erythema

Edema

Phases (hours)

1

24

48

72

1

24

48

72

Animal 1

0

0

0

0

0

0

0

0

Animal 2

0

0

0

0

0

0

0

0

Animal 3

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The test substance was assessed for skin irritation according to OECD Guideline 404. The test substance induced no dermal irritation when applied to male New Zealand white rabbits and was therefore considered a non-irritant. In addition, there was no mortality and no treatment-related clinical signs were observed.