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EC number: 684-879-1 | CAS number: 848641-69-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Apr - May 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Guidelines for the Testing of Chemical-health effects (2nd edition): 406 Skin Sensitization (China environmental press)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The study was required under Chinese chemical regulation
Test material
- Reference substance name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Cas Number:
- 848641-69-0
- Molecular formula:
- C6H11N2 C4H10O4P
- IUPAC Name:
- 1-Ethyl-3-methylimidazolium Diethyl Phosphate
- Test material form:
- liquid
- Details on test material:
- Batch No 187-9-113-Y
Expiry date: 2021-1-30
Constituent 1
- Specific details on test material used for the study:
- Lot no.: 187-9-113-Y
Purity: >/=98.0%
light yellow liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tianjin Yuda Experimental Animal Breeding Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: no data
- Weight at study initiation:
females: 208 - 230 g; males: 205 - 235 g
- Housing: stainless steel cage (LxWxH: 500 mm x 370 mm x 195 mm)
- Diet (e.g. ad libitum): formula feed for Guines pigs, Jaingsu Xietong Pharmaceutical Bio-enginering Co., Ltd., 35 g/day each animal
- Water (e.g. ad libitum): water from animal water dispenser (regularly analysed), ad libitum
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 - 25.4 °C
- Humidity (%): 39.2 - 71.8 %
- Air changes (per hr): >/= 8
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES:
From: 25.04. To: 30.05.2019
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 mL of pure test substance
- Day(s)/duration:
- On days 0, 7 and 14 for 6 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.2 mL of pure test substance
- Day(s)/duration:
- On day 28 for 6 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Negative control:
5 females, 5 males
Psotive control:
5 females, 5 males
Test substance:
10 females, 10 males - Details on study design:
- RANGE FINDING TESTS:
pre test for skin irritation reaction was performed.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 0, 7 and 14)
- Exposure period: 6 h each
- Test groups: 0.2 mL of pure test substance
- Control group:
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: no treatment during induction phase
- Site: approx. 4-6 cm(2) clipped area on the left flank
- Frequency of applications: once per application time
- Duration: 6 h
- Concentrations: 0.2 mL of pure test substance and 0.2 mL of 25% positive control substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (day 28)
- Day(s) of challenge: 1
- Exposure period: 6 h
- Test groups:
0.2 mL of pure substance
- Control group:
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: 0.2 mL of pure substance
- Site: clipped skin of the right flank
- Concentrations:
test item: 0.2 mL of pure substance
positive control: hexyl cinnamic aldehyde; 0.2 mL of 25% positive control substance
negative control: 0.2 mL of pure substance
- Evaluation (hr after challenge): 24 and 48 h after removal of patches - Positive control substance(s):
- yes
- Remarks:
- 25% hexyl cinnamaldehyde
Results and discussion
- Positive control results:
- In the poisitve control group, 2 female animals and 1 male animal showed erythema after challenge exposure. The sensitisation rate was 30%. Thus, the positive control substance has to be classified as moderate sensitiser.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.2 mL pure test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormal signs observed, no changes in body weight gain
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL pure test item
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no effects observed
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- n.a.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2 mL of 25% positive control item
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2 mL of 25% positive test item
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Clinical observations:
- no effects observed
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Clinical observations:
No abnormal signs related to the test substance were observed in the animals during the test.
Body weights:
The animals in each group were weighed before and after the test. There was no obvious abnormal change in body weight.
Observation and scoring of the skin reaction:
No erythema and edema in skin were found in the negative control and test substance group. The scores of skin reaction were 0. In the positive group, 2 of 5 females and 1 of 5 males showed erythema in the skin (score 1).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitsation rate of the test item group was 0%. Therefore, the substance is considered to be non-sensitising.
- Executive summary:
To investigate the sensitising potential of the test substance a guideline compliant GLP study was performed according to the Bühler method.
A total of 40 guinea pigs were assigned to 3 groups:
- negative control: 5 males and 5 females
- positive control: 5 males and 5 females
- test control: 10 males and 10 females
24 h before the test, the left flank was cleared of hair (closely clipped) about 4 -6 cm2. On days 0, 7 and 14 the trst item was applied on a patch to the clipped skin of the left flank for 6 h for induction. On day 28 the test substance was applied on a patch to the clipped skin of the right flank for 6 h for challenge. 24 h anf 48 h after removal of the patches the skin reactions were scored.
In the positive control group 0.2 mL of 25% hexyl cinnamaldehyde was administered. There animals were treated identically to the test group. In the negative control group, the animals were challenged in the same way like the test group animals.
The results showed that under the conditions of this study, in the positive control group 2 of 5 females and 1 of 5 males developed erythema after the challenge treatment and the sensitisation rate was 30%. No skin reactions were observed in the negative and test substance group and the sensitisation rate was 0%. From the before mentioned results, it can be confirmed that the test system is stable and reliable.
The test substance is concluded to be no skin sensitiser.
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