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Registration Dossier
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EC number: 218-566-4 | CAS number: 2184-11-4
Endpoint summary
Administrative data
Description of key information
For the skin irritation test, the dorsal part of three New Zealand white rabbits after single dermal application with the test article for 4 hours were observed by experienced veterinarian, and found that there was no irritation response within 72 hours after patch removal. The primary irritation index (PII) of the test article was zero.
For the eye irritation test, the local irritation response of the rabbit eye were evaluated within 72 hours after the application. The result of this study indicated that all the three rabbit did not show any eye irritation response after application of the test article.
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:
- 2014-11-25~2014-11-28
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Duration of treatment / exposure:
- Test article in a dose of 0.5 g were applied topically on backside skin of test animals for 4 hrs.
- Observation period:
- 1, 24, 48 and 72 hrs after patch removal
- Number of animals:
- Three female New Zealand white rabbits
- Irritation parameter:
- erythema score
- Basis:
- animal: 70
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 70
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- erythema score
- Basis:
- animal: 71
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 71
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- erythema score
- Basis:
- animal: 72
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no erythema
- Irritation parameter:
- edema score
- Basis:
- animal: 72
- Time point:
- other: 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: no edema
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: overall at 1, 24, 48 and 72 hrs
- Score:
- 0
- Remarks on result:
- other: non-irritant
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dorsal part of three New Zealand white rabbits after single dermal application with the test article for 4 hours were observed by experienced veterinarian, and found that there was no irritation response within 72 hours after patch removal. The primary irritation index (PII) of the test article was zero.
- Executive summary:
According to OECD Guideline 404 (Acute Dermal Irritation / Corrosion), the test article was considered as non-irritant on the skin of the New Zealand white rabbits. The test results are "non irritating", so that hazard category in CLP is not classified.
Reference
Table 1 : Body weight of the rabbits
Animal I.D. |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
70 |
Female |
2.0206 |
2.1040 |
71 |
Female |
2.0326 |
2.0998 |
72 |
Female |
2.0328 |
2.1106 |
Table 2 : Individual skin reaction
Animal I.D. |
Observation time (hours) |
Grading (erythema/edema) |
|||
Test area |
Control area |
||||
70 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
71 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
1 |
0/0 |
0/0 |
0/0 |
0/0 |
24 |
0/0 |
0/0 |
0/0 |
0/0 |
|
48 |
0/0 |
0/0 |
0/0 |
0/0 |
|
72 |
0/0 |
0/0 |
0/0 |
0/0 |
|
Table 3 : Individual animal primary irritation scores
Animal I.D. |
Scores |
Primary Irritation Scores (PIS) |
|
Test area |
Control area |
||
70 |
0 |
0 |
0 |
71 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
Primary Irritation index (PII) = 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:
- 2014-11-24~2014-11-28
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- A dose of 0.1 g test article was applied to the conjunctival sac of the left eye of each rabbit. After application, the lid were gently held together for about 5~10 seconds. And right eye of each rabbits was served as blank control.
- Observation period (in vivo):
- 1, 24, 48, 72 hours after test article application
- Number of animals or in vitro replicates:
- Three female New Zealand white rabbits
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 67
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 68
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity, Area
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness, Chemosis, Discharge
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Irritation parameter:
- iris score
- Basis:
- animal: 69
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Remarks on result:
- other: test group : left eye ; blank control group : right eye
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The local irritation response of the rabbit eye were evaluated within 72 hours after the application. The result of this study indicated that all the three rabbit did not show any eye irritation response after application of the test article.
- Executive summary:
According to OECD Guideline 405 (Acute Eye Irritation / Corrosion), the test article was considered as non-irritant on the eye of the New Zealand white rabbits. The test results are "not irritating", so that hazard category in CLP is not classified.
Reference
Table 1 : Body weight of the rabbits
Animal I.D. |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
67 |
Female |
2.0708 |
2.1146 |
68 |
Female |
2.0906 |
2.1350 |
69 |
Female |
2.1026 |
2.1906 |
Table 2 : Individual response of the test rabbits
Animal I.D. |
Time (hour) |
|
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
67 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
68 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
69 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on these results, Everdirect SH05 is not classified for eye irriation and skin irritation according to CLP (EC1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
