Registration Dossier
Registration Dossier
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EC number: 245-876-7 | CAS number: 23779-32-0
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP. Since this study is a read-across from CAS 116912-64-2, the reliability downgraded from RL1 to RL2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 116912-64-2
- Cas Number:
- 116912-64-2
- IUPAC Name:
- 116912-64-2
- Reference substance name:
- -
- EC Number:
- 449-160-7
- EC Name:
- -
- IUPAC Name:
- 449-160-7
- Reference substance name:
- Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters
- IUPAC Name:
- Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters
- Details on test material:
- - Name of test material (as cited in study report): A-1160 (methanol stripped)
- Physical state: clear, colourless liquid
- Substance type: Alkoxysilane
- Storage condition of test material: At room temperature in the dark under nitrogen
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Biotechnology and animal breeding division (RCC Ltd.), Fuellinsdorf, Switzerland
- Age at study initiation: approx. 4 weeks
- Weight at study initiation: 294 ± 14 g (control group), 308 ± 16 g (experimental group)
- Housing: 5 animals per metal cage
- Diet: Standard guinea pig diet including ascorbic acid (1000 mg/kg); Charles River breeding and maintenance diet for guinea pigs, Altromin, Lage, Germany, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction: 0.5 ml of undiluted test substance (experimental group); 0.5 ml of water (control group)
Challenge: 0.15 ml of undiluted test substance + 0.15 ml of water (all animals)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Induction: 0.5 ml of undiluted test substance (experimental group); 0.5 ml of water (control group)
Challenge: 0.15 ml of undiluted test substance + 0.15 ml of water (all animals)
- No. of animals per dose:
- Control group: 10 animals
Experimental group: 20 animals - Details on study design:
- RANGE FINDING TESTS:
In a range finding test the application of undiluted test substance to 2 animals did not reveal any erythema or edema findings 24 and 48 h after exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (day 1, 8, and 15)
- Exposure period: 6 h
- Test groups: 0.5 ml undiluted test substance
- Control group: 0.5 ml water
- Site: left side of the scapular region
- Frequency of applications: every 7 days
- Duration: day 1-15
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.15 ml undiluted test substance + 0.15 mL water
- Control group: 0.15 ml undiluted test substance + 0.15 mL water
- Site: right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24, 48 - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
- Remarks:
- The sensitivity of the test system was checked at least every 6 months.
Results and discussion
- Positive control results:
- No positive control was used with this study, but data are available showing that a reliability check is carried out at regular intervals. The positive control substance (Alpha-hexylcinnamic aldehyde) was used for a reliability check, and induced positive reactions in 60% of the animals, thus meeting the reliability criteria for the Buehler test (≥ 15% positive response).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a Buehler Test conducted to GLP and OECD 406 (reliability score 1) ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters was not sensitising to the skin.
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