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EC number: 701-408-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20th of November 2019 to 20th of February 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Adopted the 17th of July 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the test method is not considered to be suitable for substances that contain silicon.
Buehler test was selected based on that in vitro methods for assessing sensitisation potential are available but cannot yet fully substitute the animal tests. The sensitivity and reliability of the experimental technique is assessed on a regular basis using mercaptobenzothiazole, which is recommended by the OECD 406 and is known to have moderate skin sensitisation properties.
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females nulliparous and non-pregnant: N/a
- Microbiological status of animals, when known: Not specified
- Age at study initiation: Approximately 5-6 weeks
- Weight at study initiation: 343 - 387 grams
- Housing: Semi barrier in an air-conditioned room.
- Diet: Autoclaved hay and Altromin 3122 maintenance diet for guinea pigs, rich in crude fibre, ad libitum .
- Water: Tap water, ad libitum.
- Acclimation period: At least 5 days
- Indication of any skin lesions: None reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): At least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
- IN-LIFE DATES: From: not reported To: 20th of February 2020
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone, extra dry
- Concentration / amount:
- 100%
- Day(s)/duration:
- Occlusive dressing kept in contact with the skin for 6 hours; induction was repeated once a week for three consecutive weeks.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 100%
- Day(s)/duration:
- Occlusive dressing kept in contact with the skin for 6 hours.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS: 5 animals were used. The adequate concentrations for the induction and challenge was determined by a preliminary test with different concentrations. The test item was applied topically at 5 different concentrations (25%; 50%; 75%; 90% or 100%, each diluted with the vehicle acetone) to the flanks of the animals for 6 hours using occlusive dressings. Based on the gained result of this preliminary test, a concentration of 100% for the dermal induction and 100% for the challenge application respectively was used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 exposures
- Exposure period: 3 weeks
- Test groups: Test groups treated with 100% of the test substance.
- Control group: The negative control was a dry gauze patch (since the test item was applied undiluted)
- Site: Flanks
- Frequency of applications: Once a week
- Duration: 6 hours
- Concentrations: 100% test substance
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: 14 days after the last induction
- Exposure period: 6 hours
- Test groups: The right flanks of 20 animals were treated with 0.5 mL of 100% test item in acetone.
- Control group: The left flanks of 10 animals were treated with 0.5 mL of acetone only.
- Site: Both flanks
- Concentrations: 100% test item in acetone.
- Evaluation (hr after challenge): At 24 and 48 hours. - Challenge controls:
- A dry patch was applied to an area of approximately 2.5 x 2.5 cm on the left flank at an untreated site (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours for the negative control.
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive control substance 2-mercaptobenzothiazole (25% in vaseline) was 90%, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2-mercaptobenzothiazole
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Clinical observations:
- 90% of positive control animals showed skin sensitisation
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2-mercaptobenzothiazole
- No. with + reactions:
- 16
- Total no. in group:
- 20
- Clinical observations:
- 80% of positive control animals showed skin sensitisation
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Frequency of Sensitisation in Positive-Control Animals
20 animals used for positive-control group
Group / Time of Observation |
E0 |
E1 |
E2 |
E3 |
O0 |
O1 |
O2 |
O3 |
Sensitised Animals (%) |
C/24 |
10 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
C/48 |
10 |
0 |
0 |
0 |
10 |
0 |
0 |
0 |
0 |
T/24 |
2 |
18 |
0 |
0 |
20 |
0 |
0 |
0 |
90 |
T/48 |
4 |
12 |
4 |
0 |
20 |
0 |
0 |
0 |
80 |
E0–E3 = erythema grade 0–3; O0–O3 = oedema grade 0–3; 0–20 = number of animals T = test group (2-mercaptobenzothiazole: 25% in vaseline); C = control group; 24/ 48 = 24/48 hours after end of challenge treatment
Table 2: Individual Grading of Reactions after Challenge
|
Negative-Control Group |
||||||||
Animal No. |
Conc. % |
24 hoursafter patch removal |
48 hoursafter patch removal |
||||||
Test Item |
Control |
Test Item |
Control |
||||||
E |
O |
E |
O |
E |
O |
E |
O |
||
21 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
23 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
26 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
27 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
28 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
29 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Test Group |
||||||||
Animal No. |
Conc. % |
24 hoursafter patch removal |
48 hoursafter patch removal |
||||||
Test Item |
Control |
Test Item |
Control |
||||||
E |
O |
E |
O |
E |
O |
E |
O |
||
1 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
4 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
7 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
8 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
9 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
11 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
14 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
15 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
16 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
17 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
18 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
19 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
20 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
E = erythema; O = oedema; 0 – 3 = grade
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vivo skin sensitisation study, conducted according to OECD Test Guideline 406 and in compliance with GLP, the test material was concluded to not be sensitising to skin. Positive and negative controls were included and gave the expected results.
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