Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 477-700-1 | CAS number: 883794-93-2
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-12-21 - 1008-02-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate test guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- -
- EC Number:
- 477-700-1
- EC Name:
- -
- Cas Number:
- 883794-93-2
- Molecular formula:
- Hill formula: C18H36N2O6S2Si2 CAS formula: C18H36N2O6S2Si2
- IUPAC Name:
- 1-{3-[(3-{2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecan-1-yl}propyl)disulfanyl]propyl}-2,8,9-trioxa-5-aza-1-silabicyclo[3.3.3]undecane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Lab, Kissleg, Germany
- Weight at study initiation: test group: 359.7±18.9 g and control group: 341.2±18.7 g
- Housing: 2 or 3 animals in Makrolon(r)-cages No.VI
- Diet (e.g. ad libitum): as pellet (3023 /Altromin Inten. Lage, Germany)
- Water (e.g. ad libitum): tap water
- Acclimation period: 13 days before the main experiment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): 8
- Photoperiod (hrs dark / hrs light): 12 h light/dark-cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mixture of sesame oil and acetone (4:1 w/w)
- Concentration / amount:
- induction and challange: 60 % (w/w)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mixture of sesame oil and acetone (4:1 w/w)
- Concentration / amount:
- induction and challange: 60 % (w/w)
- No. of animals per dose:
- test group: 20
control group: 10
pilot experiment: 6 - Details on study design:
- RANGE FINDING TESTS:
induction and challange: During chambers with soaked patches; either with 25%; 60%; or 80% (w/w) test substance preparation in vehicle
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 2 weeks
- Test groups: 1 (20 animals)
- Control group: 1 (6 animals)
- Site: shaved skin on the left flank
- Frequency of applications: day 0; after 7 and 14 days
- Duration: 6 h
- Concentrations: 60 % (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: day 28 of the application period
- Exposure period: 6 h
- Test groups: 1 (20 animals)
- Control group: 1 (6 animals)
- Site: on the shaved untreated right flank
- Concentrations: 60% (w/w)
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole 98% in sesame oil/acetone 4:1 (w/w)
Results and discussion
- Positive control results:
- sensitisation rate: 25%
A total of 5 out of 20 animals were tested positive, 2 thereof showed skin reactions only during 1st reading 24 hours after challeng, 2 animals showed skin reactions only during 2nd reading 48 hours after challenge, and one animal showed skin reactions during both 1st and 2nd reading.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60 % (w/w) test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 60 % (w/w) test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60 % (w/w) test substance in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 60 % (w/w) test substance in corn oil. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 60% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 60% (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 60 % (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 60 % (w/w). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 98%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 98%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 98%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 98%. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: no data.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance has to be regarded as non-sensitising under the applied test conditions when exposed to the skin of experimental animals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
