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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 209-136-7 | CAS number: 556-67-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23.07.1984 to 27.08.1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA 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:
- Octamethylcyclotetrasiloxane
- EC Number:
- 209-136-7
- EC Name:
- Octamethylcyclotetrasiloxane
- Cas Number:
- 556-67-2
- Molecular formula:
- C8H24O4Si4
- IUPAC Name:
- 2,2,4,4,6,6,8,8-octamethyl-1,3,5,7,2,4,6,8-tetroxatetrasilocane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: no data; albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co KG, D-4799 Borchen
- Age at study initiation: No data (may have been missed in translation)
- Weight at study initiation: 425-555 g
- Housing: Groups of 3, 4 or 5 in Makrolon Type IV cages
- Diet (e.g. ad libitum): 8 kg/week for 120 animals
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 45%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 23.07.1984 To: 27.08.1984
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 100 and 1%
Challenge: 100 and 10%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction: 100 and 1%
Challenge: 100 and 10%
- No. of animals per dose:
- 20 test group
10 negative control - Details on study design:
- RANGE FINDING TESTS: Four formulations per animal (12.5, 25, 50 and 100%) were occlusively applied to the shaved flank skin (24 hours, each area approximately 2.5x2.5 cm). No further details could be translated.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two
- Exposure period: 48 hours
- Test groups: 1% intradermally (100% in 2nd induction epicutaneously) D4 in paraffin oil, 1% (100% in 2nd induction) D4 in FCA (50% in paraffin oil)
- Control group: FCA alone, paraffin oil alone, and paraffin oil with FCA
- Site: Flank
- Frequency of applications: Weekly
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: 24 hours
- Test and control groups: 100 and 10 % D4 in paraffin oil
- Site: Flank
- Concentrations: 100 and 10%
- Evaluation (hr after challenge): 48, 72 and 96 - Challenge controls:
- FCA in vehicle and vehicle alone.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- There was no positive control in this study.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10% or 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- other: There was no positive control in this study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea-pig maximisation test (GMPT) conducted to OECD 406 and GLP (reliability score 1), D4 was not sensitising to the skin.
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.
