Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
CJ307 is not classified based on the sensitization result in guinea pigs (OECD TG406).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 05, 2016 to November 11, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The structure of the read-across substance, EC:300-504-3, is the same as the test substance. Therefore, the human toxicity and environmental toxicity is the same. The only difference is the test substance containing lithium. However, the low level of lithium will not change the classification.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.
- Specific details on test material used for the study:
- Evercion SR61, Reactive red 3-1, EC: 300-504-3
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 330.4-500.0g
- Housing: Every five animals were housed in a stainless steel cage
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.1 mL and 0.5 mL of 10% Evercion SR61 for intradermal and epicutaneous, respectively
- Day(s)/duration:
- Day1 and Day7 for intradermal and epicutaneous, respectively
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 mL of 10% Evercion SR61
- Day(s)/duration:
- Day23
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- For control group: five
For test group: ten - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
- Positive control results:
- The latest results showed that positive control animals had shown skin reactions of 1-2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 100%.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL of 10% Evercion SR61
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL of 10% Evercion SR61
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 406 test method and “Scoring system of Kligman”, the sensitization rate of Evercion SR61 was 0% and Evercion SR61 caused weak sensitization in guinea pigs. Therefore, Evercion SR61 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100095001EN which is based on the SOP for the OECD 406 (SOPP-339) and OECD 406 (OECD, 1992). The results of this OECD 406 test forEvercion SR61show that test reliability criteria was met.
A 10% Evercion SR61 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization.The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 10% Evercion SR61.The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 0% treated animals showed sensitization to the Evercion SR61. Under the conditions of this study, Evercion SR61 did not caused any sensitization in guinea pigs.
Reference
Table 1. The body weight of the guinea pigs
Group |
Sex |
Animal ID. |
Animal Weight (g) |
Weight Change (g) |
|
Day 1 |
Day 26 |
||||
Control group |
Male |
26 |
379.6 |
468.0 |
+88.4 |
27 |
388.3 |
483.2 |
+94.9 |
||
28 |
404.0 |
525.0 |
+121.0 |
||
29 |
330.4 |
446.0 |
+115.6 |
||
30 |
415.8 |
508.6 |
+92.8 |
||
Test group |
Male |
31 |
408.2 |
504.2 |
+96.0 |
32 |
398.2 |
491.2 |
+93.0 |
||
33 |
381.0 |
484.6 |
+103.6 |
||
34 |
435.6 |
540.4 |
+104.8 |
||
35 |
452.0 |
556.2 |
+104.2 |
||
36 |
500.0 |
582.2 |
+82.2 |
||
37 |
413.8 |
486.2 |
+72.4 |
||
38 |
393.0 |
489.2 |
+96.2 |
||
39 |
490.6 |
587.4 |
+96.8 |
||
40 |
334.6 |
449.6 |
+115.0 |
||
Table 2. Individual skin reaction of guinea pigs
Group |
Sex |
Animal ID. |
Grade of skin reactiona |
Percent of Animals Sensitized |
Sensitizing Capacityb |
|
24 ± 1 hrs |
48 ± 1 hrs |
|||||
Control group |
Male |
26 |
0 |
0 |
0 |
Weak |
27 |
0 |
0 |
||||
28 |
0 |
0 |
||||
29 |
0 |
0 |
||||
30 |
0 |
0 |
||||
Test group |
Male |
31 |
0 |
0 |
0 |
Weak |
32 |
0 |
0 |
||||
33 |
0 |
0 |
||||
34 |
0 |
0 |
||||
35 |
0 |
0 |
||||
36 |
0 |
0 |
||||
37 |
0 |
0 |
||||
38 |
0 |
0 |
||||
39 |
0 |
0 |
||||
40 |
0 |
0 |
||||
a The skin reaction was grading according to “Magnusson and Kligman scale”.
b The sensitizing capacity of the test article was classified according to the “Scoring system of Kligman”
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization
CJ307 is not classified as skin sensitizer. The result is read-across from Evercion SR61 due to the similar structure. The test detail of Evercion SR61 is described below.
A 10% Evercion SR61 was used for intradermal injection and occlusively patched, to ten test guinea pigs to induce sensitization. The normal saline was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 10% Evercion SR61. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. At the end of study, body weight increase was observed in all animals. During 48 hours after challenge exposure, 0% treated animals showed sensitization to the Evercion SR61. Under the conditions of this study, Evercion SR61 did not caused any sensitization in guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
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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