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EC number: 945-544-8 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 June 2017 to 15 August 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- 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. Please refer to the attached document for further details.
Test material
- Reference substance name:
- bis(trimethoxysilylpropyl)methylphosphonate
- Molecular formula:
- C13H33O9PSi2
- IUPAC Name:
- bis(trimethoxysilylpropyl)methylphosphonate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, under nitrogen
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test substance was dissolved in acetone.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dosing solutions for the primary irritation phase were prepared by dilution of test substance in acetone. All procedures were performed in a glove box under nitrogen. All dose formulations were stirred until uniform.
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Canada
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: young adults
- Weight at study initiation: 615-750 g males and 509-672 g females
- Housing: individually in suspended wire-mesh cages
- Diet (e.g. ad libitum): certified guinea pig diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1-23.2°C
- Humidity (%): 35.4-50.8%
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours, 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:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- single application for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- test group: 10 males and 10 females
negative control group: 5 males and 5 females - Details on study design:
- RANGE FINDING TESTS: Single application of multiple concentrations of the test substance to determine an irritation score. Four guinea pigs per sex were exposed to the different concentrations for 6 hours under occlusive dressing.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: three consecutive weeks
- Test groups: 10 male and 10 female animals
- Control group: 5 male and 5 female animals
- Site: left flank of all test animals
- Frequency of applications: one a week
- Duration: 6 hours
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: two weeks after last induction exposure
- Test groups: 0 male and 10 female animals
- Control group: 5 male and 5 female animals
- Site: right flank of all test animals
- Concentrations: 100%
- Evaluation (hr after challenge): at 24 and 48 hours
- Challenge controls:
- Negative controls
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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%
- 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:
- 100% test substance on untreated area at induction
- 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:
- 100% test substance on untreated area at induction
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: Positive control data were not generated as part of this study.
- Remarks:
- Charles River historical positive control data from a study conducted within 6 months of this test were used to demonstrate the reliability of this test. The positive control group exhibited an incidence index of 0% following challenge exposure. The response requirement for a non-adjuvant positive control group is at least 15%. As a result, a rechallenge was conducted for the positive control group. Following rechallenge, the positive control article, a-hexylcinnamaldehyde (HCA), was a sensitiser when administered as both 10% concentration (20% incidence index) and 20% concentration (80% incidence index), supporting the sensitivity and reliability of the experimental design.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the skin sensitisation study, conducted according to OECD 406 TG and in compliance with GLP, the test substance Reaction Mass of bis(trimethoxysilylpropyl)methylphosphonate and (trimethoxysilylpropyl)methylmethylphosphonate was reported to be not sensitising to skin.
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