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EC number: 815-135-8 | CAS number: 1386899-40-6
Endpoint summary
Administrative data
Description of key information
Skin irritation
The Primary Irritation Index (PII) of CR SB37 was 0 and CR SB37 was categorized as non-irritant (OECD TG404).
Eye irritation
CR SB37 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 October 3, 2017 to March 6, 2018
- 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: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one rabbit per 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 physiological saline
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24,48 and 72 hours
- 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:
- 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
- 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 CR SB37 was 0 and CR SB37 was categorized as non-irritant. Therefore, CR SB37 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-170900008002EN 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 CR SB37 was calculated to be 0. On the basis of the test results given above and according toEvaluation table for single dermal irritation, the response of CR SB37 was categorized as non-irritant.
Reference
Table 1. The body weight of the rabbits during the study period
Animal ID |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
180 |
Male |
2.86 |
2.90 |
181 |
Male |
3.12 |
3.13 |
182 |
Male |
2.85 |
2.92 |
Table 2. The results of rabbit skin irritation response
Animal I.D. |
Observation time (hours) |
Skin grading (erythema / edema) |
|||
Test area |
Control area |
||||
180 |
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 |
|
181 |
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 |
|
182 |
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. Primary irritation scores of rabbit skin irritation test
Animal I.D. |
Irritation scoresa |
Primary Irritation Scores (PIS)b |
|
Test area |
Control area |
||
180 |
0 |
0 |
0 |
181 |
0 |
0 |
0 |
182 |
0 |
0 |
0 |
Primary Irritation Index (PII)c= 0 |
|||
a Irritation scores were the sum of each rabbit irritation values at three time points and then divided 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 October 03, 2017 to March 06, 2018
- 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: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one animal per 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, 48 and 72 hours
- Number of animals or in vitro replicates:
- Three
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405 test method, CR SB37 showed that no irritant to the eye. Therefore, CR SB37 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-170900009002EN 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. CR SB37 was given by a single ocular application at 0.1 g amount toNZW male rabbits and followed by ocular examination within 72 hours. Three rabbits did not show any eye irritation response after application of CR SB37 and irritation responses were 0. On the basis of the test results given above, the response of CR SB37 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 |
||
177 |
Male |
3.02 |
3.10 |
178 |
Male |
2.89 |
2.93 |
179 |
Male |
2.70 |
2.80 |
Table 2. Eye response of the eye irritation test
Animal I.D. |
Timea (hour) |
Group |
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
177 |
1 |
Testb |
0 |
0 |
0 |
0 |
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 |
||
178 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
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 |
||
179 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
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)
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 was no formation of erythema, eschar or edema on the test area within 72 hours after patch removal. The Primary Irritation Index for CR SB37 was calculated to be 0. On the basis of the test results given above and according toEvaluation table for single dermal irritation, the response of CR SB37 was categorized as non-irritant.
Eye irritation
There were no test article effects on body weight. CR SB37 was given by a single ocular application at 0.1 g amount toNZW male rabbits and followed by ocular examination within 72 hours. Three rabbits did not show any eye irritation response after application of CR SB37 and irritation responses were 0. On the basis of the test results given above, the response of CR SB37 was not any irritant to the eye.
Justification for classification or non-classification
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.
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