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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation
The Primary Irritation Index (PII) of CJ303 was 0 and CJ 303 was categorized as non-irritant (OECD TG404).
Eye irritation
CJ 303 was not any irritant to the eye(OECD TG405).
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:
- From May 9, 2016 to October 19, 2016
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 2.0342 to 2.5128 kg
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12hrs dark / 12hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.5 mL normal saline
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24 ± 1, 48 ± 1, 72 ± 1 hrs
- Number of animals:
- three
- Details on study design:
- - Area of exposure: upper left and lower right dorsal area
- Washing (if done): with distilled water - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 404 test method and Evaluation table for single dermal irritation, the PII for CJ303 was 0 and CJ303 was categorized as non-irritant. Therefore, CJ303 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100143001EN which is based on the SOP for the OECD 404 (SOPP-305) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CJ303 was calculated to be 0. On the basis of the test results given above and according to Evaluation table for single dermal irritation, the response of CJ303 was categorized as non-irritant.
Reference
Table 1. Body weight of the rabbits
Animal ID |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
64 |
Female |
2.0854 |
2.1120 |
65 |
Female |
2.5128 |
2.5532 |
66 |
Female |
2.0342 |
2.0730 |
Table 2. Individual skin reactions
Animal I.D. |
Observation time (hours) |
Grading (erythema / edema) |
|||
Test area |
Control area |
||||
64 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
65 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
66 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 ± 1 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Table 3. Individual animal primary irritation scores
Animal I.D. |
Scoresa |
Primary Irritation Scores (PIS)b |
|
Test area |
Control area |
||
64 |
0 |
0 |
0 |
65 |
0 |
0 |
0 |
66 |
0 |
0 |
0 |
Primary Irritation Index (PII)c= 0 |
|||
a Sum of scores at all time intervals on backside skin in each rabbit and divided the sum by the total number of observation.
b PIS = (scores of test area) – (scores of control area).
c PII = Sum of PIS ÷ number of animals.
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:
- From May 9, 2016 to October 19, 2016
- 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 2.0870-2.1238 kg
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- 1 hours
- Observation period (in vivo):
- 1, 24 ± 1, 48 ± 1, 72 ± 1 hours
- Number of animals or in vitro replicates:
- three
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0 - 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405 test method, CJ303 showed that no irritant to the eye. Therefore, CJ303 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100144001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). There were no test article effects on body weight. Reversiblechemosisanddischargeof conjunctivae with score of 1 were observed within 1 hours after test article application. CJ303 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. Conjunctivachemosisanddischargewith score 1 were determined within 24 hours and fully recovered. On the basis of the test results given above, the response of the test article was not any irritant to the eye.
Reference
Table 1. Body weight of the rabbits
Animal ID |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
58 |
Female |
2.0870 |
2.1260 |
59 |
Female |
2.1238 |
2.1887 |
60 |
Female |
2.0874 |
2.1322 |
Table 2. Individual response of the test rabbits
Animal I.D. |
Timea (hour) |
|
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
58 |
1 |
Testb |
0 |
0 |
0 |
1 |
0 |
0 |
Controlc |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
59 |
1 |
Test |
0 |
0 |
0 |
1 |
1 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
60 |
1 |
Test |
0 |
0 |
0 |
1 |
1 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
a Observation time was started after application of the test article
b Left eye of the test rabbits
c Right eye of the test rabbits
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. All animals were no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CJ303 was calculated to be 0. On the basis of the test results given above and according to the Evaluation table for single dermal irritation, the response of CJ303 was categorized as non-irritant.
Eye irritation
There were no test article effects on body weight. Reversible chemosis and discharge of conjunctivae with score of 1 were observed within 1 hours after test article application.CJ303 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period.Conjunctivachemosisanddischargewith score 1 were determined within 24 hours and fully recovered. On the basis of the test results given above, the response of the test article was not any irritant to the eye.
Justification for classification or non-classification
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