Registration Dossier

Administrative data

Description of key information

Skin irritation negative (OECD 404).  Eye irritation negative (OECD 405)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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
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.
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.

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

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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2009-04-07 to 2009-09-01
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Specific details on test material used for the study:
Batch No.: 20090226
Purity: 99.38%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Orient Bio, Ltd, 143-1 Sangdaewon-Dong, Jungwon-Gu, Seongnam-Si, Gyeonggi-Do, Korea
- Age at study initiation: 2 months
- Weight at study initiation: 1900 to 2079 g; the 3 rabbits selected for the study ranged from 2193 to 2445.
- Housing: During acclimation, quarantine and the test period, rabbits were hosued individually in 3 lines x 4 ros of stainless acges (590 mm w x 460 mm l x 360 mm h).
- Diet (e.g. ad libitum): Pelleted food was obtained from Purina Korea and was available ad libitum
- Water (e.g. ad libitum): Municipal tap water was available ad libitum following uv irradiatio and filtration.
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 - 20 times/h
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle with a light intensity of 150 - 300 lux.

IN-LIFE DATES: From: To:
Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye of each animal remained untreated as a control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hrs (observations at 1 hr, 24 hrs, 48 hrs, 72 hrs after application)
Number of animals or in vitro replicates:
3 male
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There was no positive reponse in any animal at any time point.
Observations performed at 1, 24, 48 and 72 h after the application elucidated no irritative response on cornea, iris or conjunctiva. The acute eye irritation index of the test item was calculated to be 0.
Other effects:
Clinical signs and mortality
There were no deaths or detecable clinical signs in any test animals which coud be attributed to the test item.

Body weight
No treatment-related body weight changes were observed.

Results of eye reaction

Animal No.

 

1

2

3

Cornea opacity

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Iris

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Conjunctiva redness

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Chemosis

1 hour

0

0

0

24 hours

0

0

0

48 hours

0

0

0

72 hours

0

0

0

Interpretation of results:
other: not irritating
Conclusions:
The test substance was assessed for eye irritation in three healthy New Zealand white rabbits. No clinical sings, body weight changes, body weight changes, dead animals or abnormal eye reaction considered to be due to test item were observed. The test item was considered to be non-irritating to eyes.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In an in vivo skin irritation study to OECD guideline 404 and GLP, the substance was found not to be irritating to skin.

Eye irritation

In an in vivo eye irritation study to OECD guideline 405 and GLP, the substance was found not to be irritating to eyes.

Justification for classification or non-classification

Skin irritation/corrosion: Mean scores at 24, 48 & 72 hours for erythema were <2.3 (actual value 0) and for edema were <2.3 (actual value 0).

Serious eye damage/eye irritation: Mean scores at 24, 48 & 72 hours for corneal opacity were <1 (actual value 0), for iris were <1 (actual value 0), for conjunctival redness were <2 (actual value 0) and for chemosis were <1 (actual value 0).

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.2.2 & 3.3.2, this substance should not be classified for the Skin irritation/corrosion and Serious eye damage/eye irritation endpoints.