Registration Dossier
Registration Dossier
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EC number: 454-190-9 | CAS number: 324763-51-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Remarks:
- Research Institute for Organic Syntheses
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The available test is available since 2003 and is adequate for hazard assessment
Test material
- Details on test material:
- - Physical state: solid (white powder)
- Analytical purity: 99.1%
- Lot/batch No.: CHAD 0207
- Storage condition of test material: in the dark, at laboratory conditions
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Breeding station AnLab, Praha
- Age at study initiation: young adult
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimally 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Vaselinum album and Olive oil raffinatum
- Concentration / amount:
- a) Induction - Intradermal injections
:
20 % test item in olive oil
b) Induction - Topical application : 50% test item in vaseline
c) Challenge- Topical application: 0.5% test item in vaseline
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaselinum album and Olive oil raffinatum
- Concentration / amount:
- a) Induction - Intradermal injections
:
20 % test item in olive oil
b) Induction - Topical application : 50% test item in vaseline
c) Challenge- Topical application: 0.5% test item in vaseline
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Details on study design:
- RANGE FINDING TESTS:
Induction - Intradermal injections
- 0.1 ml 20 % test item in olive oil: discrete erythema= suitable
Induction - Topical application
- 50 % test item in vaseline: erythema = suitable
- 20 % test item in vaseline: no visible change = unsuitable
Challenge - Topical application
- 5 % test item in vaseline: very discrete erythema = unsuitable
- 1% test item in vaseline: no visible change = suitable
- 0.5 % test item in vaseline: no visible change = suitable
Note: before the topical induction it is necessary to apply sodium lauryl suphate in vaseline in order to induce a local irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal induction, 1 topical application
- Exposure period: topical application: 48 hours
- Test groups: 1
- Control group: 1
- Site: shoulder region
- Frequency of applications: three pairs of intradermal induction, one topical application
- Duration: 19 days
- Concentrations: intradermal injection: 0.1 ml 20% test item in olive oil; topical application: 50% = 2.5g test substance and 2.5g vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flanks
- Concentrations: 0.5% = 0.05g test substance and 9.95g vaseline
- Evaluation (hr after challenge): 48 hours and 72 hours from start of application
OTHER:
Time schedule of observations:
Clinical signs: daily
Mortality/viability: daily
Body weight: day 0 and 24
Skin reaction: 24, 48 and 72 hours after intradermal injection
48, 72 and 96 hours after induction
48 and 72 hours after Challenge - Challenge controls:
- 1. 1:1 mixture (v/v) FCA/olive oil
2. olive oil
3. a 50% (v/v) formulation of olive oil in a 1:1 mixture (v/v) FCA/olive oil - Positive control substance(s):
- yes
- Remarks:
- Benzocaine (ethyl p-aminobenzoate)
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0.5%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Guinea pig maximization test
The body weight of animals increased throughout the study and it was not affected by the test substance.
Body weight in grams - mean values ± SD
| number of animals | start of study | end of study | increment | |
| Exposed group | 10 | 348.48 ± 44.31 | 480.61 ± 60.62 | 132.15 |
| Control group | 5 | 355.96 ± 51.32 | 497.64 ± 96.38 | 141.68 |
Clinical observation: In the course of experiment the animals did not show clinical symptoms of intoxication. At the end of experiment, the animals were killed by ether anaesthesia.
Evaluation of skin reactions after challenge:
Exposed group at 48 hours after the challenge: The evaluation of skin reactions in the exposed group carried out at 48 hours after the start of the challenge phase of study did not show any changes in skin of exposed flank of all animals. The other flank of the animals applied with the vaseline only did not show any skin reactions in all the 10 animals.
Exposed group at 72 hours after the challenge: The evaluation of skin reactions in the exposed group carried out at 72 hours after the start of challenge phase of study did not show any changes in skin of the exposed flank of all animals. The other flank did not show any changes in skin of all the 10 animals.
Control group at 48 and 72 hours after the challenge: The evaluation of skin reactions in the control group carried out at 48 and 72 hours after the start of the challenge phase of study did not show any changes in skin of animals in both flanks.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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