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EC number: 283-829-2 | CAS number: 84731-70-4
Endpoint summary
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
- 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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. - 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.
Reference
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 |
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.
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