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EC number: 815-135-8 | CAS number: 1386899-40-6
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Endpoint summary
Administrative data
Description of key information
CR SB37 was classified as positive reaction indicated that induced proliferation of lymphocytes in the lymph nodes (OECD TG442B).
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 15, 2017 to March 06, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
- Species:
- mouse
- Strain:
- other: CBA/CaJNarl
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: National Laboratory Animal Center
- Housing: four animals per cage
- Acclimation period: 7 days
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Photoperiod: 12-hrs dark / 12-hrs light - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 62.5, 125 and 250 mg/mL
- No. of animals per dose:
- Four
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- eugenol (CAS No 97-53-0)
- Positive control results:
- The BrdU labeling index of positive control group was 0.081 ± 0.007 and significantly higher than vehicle control group (ρ < 0.05). The stimulation index (SI) of positive control group was 2.06.
- Parameter:
- SI
- Value:
- 1.51
- Test group / Remarks:
- Low dose group (62.5 mg/ml)
- Parameter:
- SI
- Value:
- 1.68
- Test group / Remarks:
- Medium dose group (125 mg/mL)
- Parameter:
- SI
- Value:
- 2.26
- Test group / Remarks:
- High dose group (250 mg/mL)
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- According to OECD 442B test method that the stimulation index of high dose group (250 mg/mL) was ≥1.6 and statistical difference with the vehicle control group, CR SB37 was classified as positive reaction. Therefore, CR SB37 was classified as category 1B based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-170900010001EN which is based on the SOP for the OECD 442B (SOPP-347) and OECD 442B (OECD, 2010). The study included vehicle control group, positive control group, low dose group (62.5 mg/mL), medium dose group (125 mg/mL) and high dose group (250 mg/mL). Control article or test article were applied on the dorsum of two ears in each mouse of the group on day 1~3. BrdU solution was administered by intraperitoneal injection on day 5. Ear erythema was recorded on day 6, and the posterior ear lymph nodes were collected and prepared in phosphate buffer solution to cellular suspension. The BrdU content of each group was detected by ELISA kit. On day 6, the mice in each group had no erythema on the ear skin and the thickness of the ear in dose group had no significant difference compared with the vehicle control group. The stimulus index of low and medium dose group were 1.51 and 1.68 and the BrdU labeling index was no significant difference compared with vehicle control group. The stimulation index of high dose group was 2.26 and the BrdU labeling was significantly higher than vehicle control group. Therefore, CR SB37 was classified as positive reaction under the test conditions.
Reference
Table 1. Body weight of testing mice
Group |
Animal ID. |
Body Weight (g) |
Body Weight Change (g) |
|
Day 1 |
Day 6 |
|||
Vehicle control group |
01F |
20.5 |
20.6 |
+0.1 |
02F |
20.3 |
20.9 |
+0.6 |
|
03F |
20.5 |
20.7 |
+0.2 |
|
04F |
20.5 |
20.8 |
+0.3 |
|
Positive control group |
05F |
22.0 |
22.1 |
+0.1 |
06F |
20.9 |
21.0 |
+0.1 |
|
07F |
20.0 |
20.1 |
+0.1 |
|
08F |
20.1 |
21.0 |
+0.9 |
|
Low dose group |
09F |
19.6 |
20.0 |
+0.4 |
10F |
21.4 |
22.0 |
+0.6 |
|
11F |
20.6 |
20.6 |
+0.0 |
|
12F |
21.9 |
22.4 |
+0.5 |
|
Medium dose group |
13F |
20.5 |
21.0 |
+0.5 |
14F |
20.6 |
20.8 |
+0.2 |
|
15F |
21.7 |
21.9 |
+0.2 |
|
16F |
20.8 |
21.0 |
+0.2 |
|
High dose group |
17F |
20.7 |
20.9 |
+0.2 |
18F |
22.2 |
22.2 |
+0.0 |
|
19F |
20.8 |
21.0 |
+0.2 |
|
20F |
22.7 |
22.9 |
+0.2 |
Table 2.Clinical observation of testing mice
Group |
Animal ID. |
Clinical observation |
|||||
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 5 |
Day 6 |
||
Vehicle control group |
01F |
Na |
N |
N |
N |
N |
N |
02F |
N |
N |
N |
N |
N |
N |
|
03F |
N |
N |
N |
N |
N |
N |
|
04F |
N |
N |
N |
N |
N |
N |
|
Positive control group |
05F |
N |
N |
N |
N |
N |
N |
06F |
N |
N |
N |
N |
N |
N |
|
07F |
N |
N |
N |
N |
N |
N |
|
08F |
N |
N |
N |
N |
N |
N |
|
Low dose group |
09F |
N |
N |
N |
N |
N |
N |
10F |
N |
N |
N |
N |
N |
N |
|
11F |
N |
N |
N |
N |
N |
N |
|
12F |
N |
N |
N |
N |
N |
N |
|
Medium dose group |
13F |
N |
N |
N |
N |
N |
N |
14F |
N |
N |
N |
N |
N |
N |
|
15F |
N |
N |
N |
N |
N |
N |
|
16F |
N |
N |
N |
N |
N |
N |
|
High dose group |
17F |
N |
N |
N |
N |
N |
N |
18F |
N |
N |
N |
N |
N |
N |
|
19F |
N |
N |
N |
N |
N |
N |
|
20F |
N |
N |
N |
N |
N |
N |
aN = normal
Table 3. Ear thickness and skin erythema examination
Group |
Animal ID. |
Ear thickness (mm)a |
Erythema score |
||
Left-ear |
Right-ear |
Left-ear |
Right-ear |
||
Vehicle control group |
01F |
0.25 |
0.25 |
0 |
0 |
02F |
0.25 |
0.25 |
0 |
0 |
|
03F |
0.25 |
0.25 |
0 |
0 |
|
04F |
0.25 |
0.25 |
0 |
0 |
|
Positive control group |
05F |
0.25 |
0.25 |
0 |
0 |
06F |
0.25 |
0.25 |
0 |
0 |
|
07F |
0.25 |
0.25 |
0 |
0 |
|
08F |
0.25 |
0.25 |
0 |
0 |
|
Low dose group |
09F |
0.25 |
0.25 |
0 |
0 |
10F |
0.25 |
0.25 |
0 |
0 |
|
11F |
0.25 |
0.25 |
0 |
0 |
|
12F |
0.25 |
0.25 |
0 |
0 |
|
Medium dose group |
13F |
0.25 |
0.25 |
0 |
0 |
14F |
0.25 |
0.25 |
0 |
0 |
|
15F |
0.25 |
0.25 |
0 |
0 |
|
16F |
0.25 |
0.25 |
0 |
0 |
|
High dose group |
17F |
0.25 |
0.25 |
0 |
0 |
18F |
0.25 |
0.25 |
0 |
0 |
|
19F |
0.25 |
0.25 |
0 |
0 |
|
20F |
0.25 |
0.25 |
0 |
0 |
aEar thickness was examined on day 6.
Table 4. BrdU content analysis
Group |
BrdU labeling index |
Stimulation index (SI) |
Vehicle control group |
0.039 ± 0.010 |
1.00 |
Positive control group |
0.081 ± 0.007* |
2.06 |
Low dose group |
0.059 ± 0.025 |
1.51 |
Medium dose group |
0.066 ± 0.026 |
1.68 |
High dose group |
0.089 ± 0.014* |
2.26 |
* Significant different from vehicle control group (ρ< 0.05).
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The study included vehicle control group, positive control group, low dose group (62.5 mg/mL), medium dose group (125 mg/mL) and high dose group (250 mg/mL). Control article or test article were applied on the dorsum of two ears in each mouse of the group on day 1~3. BrdU solution was administered by intraperitoneal injection on day 5. Ear erythema was recorded on day 6, and the posterior ear lymph nodes were collected and prepared in phosphate buffer solution to cellular suspension. The BrdU content of each group was detected by ELISA kit. On day 6, the mice in each group had no erythema on the ear skin and the thickness of the ear in dose group had no significant difference compared with the vehicle control group. The stimulus index of low and medium dose group were 1.51 and 1.68 and the BrdU labeling index was no significant difference compared with vehicle control group. The stimulation index of high dose group was 2.26 and the BrdU labeling was significantly higher than vehicle control group. Therefore, CR SB37 was classified as positive reaction under the test conditions.
Justification for classification or non-classification
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