Registration Dossier
Registration Dossier
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EC number: 218-441-4 | CAS number: 2152-64-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP) Opinion on Octamethylcyclotetrasiloxane (D4)
- Author:
- SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP)
- Year:
- 2 005
- Bibliographic source:
- EUROPEAN COMMISSION HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL, SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS (SCCP) SCCP/0893/05, 13 December 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- A Draize test of Octamethylcyclotetrasiloxane (CAS No:556-67-2) was conducted on One male and one female New Zealand White rabbits to assess the degree of irritancy caused by the chemical.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2,2,2,2,4,4,6,6,8,8-octamethyl-1,3,5,7,2,4,6,8-tetraoxatetrasilocane
- Cas Number:
- 556-67-2
- Molecular formula:
- C8H24O4Si4
- IUPAC Name:
- 2,2,2,2,4,4,6,6,8,8-octamethyl-1,3,5,7,2,4,6,8-tetraoxatetrasilocane
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report):Octamethylcyclotetrasiloxane
- Molecular formula: C8H24O4Si4
- Molecular weight: 296.6176 g/mol
- Substance type:Organic
- Physical state: Liquid
-Smiles: C[Si]1(O[Si](O[Si](O[Si](O1)(C)C)(C)C)(C)C)C
- InChI: 1S/C8H24O4Si4/c1-13(2)9-14(3,4)11-16(7,8)12-15(5,6)10-13/h1-8H3
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Octamethylcyclotetrasiloxane
- Molecular formula: C8H24O4Si4
- Molecular weight: 296.6176 g/mol
- Substance type:Organic
- Physical state: Liquid
-Smiles: C[Si]1(O[Si](O[Si](O[Si](O1)(C)C)(C)C)(C)C)C
- InChI: 1S/C8H24O4Si4/c1-13(2)9-14(3,4)11-16(7,8)12-15(5,6)10-13/h1-8H3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Weight at study initiation:3-4 kg bw
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- Amount : 100 µl
concentration applied :100% - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 1, 24, 48, 72 h and 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- TEST SITE
-Area of exposure:conjunctival sac of one eye of each of the two rabbits
REMOVAL OF TEST SUBSTANCE
- Washing (if done):The eyes were not rinsed after treatment
- Time after start of exposure: after 1 hour
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Irritating
- Conclusions:
- The test chemical Octamethylcyclotetrasiloxane (CAS No: 556-67-2) was considered to be not irritating to the skin of New Zealand White rabbits.
- Executive summary:
A Draize test of Octamethylcyclotetrasiloxane (CAS No: 556-67-2) was conducted on One male and one female New Zealand White rabbits to assess the degree of irritancy caused by the chemical.
In this test, 100 µl neat octamethyltetracyclosiloxane was instilled into the conjunctival sac of one eye of each of the two rabbits and the lids were gently held together for about one second. The eyes were not rinsed after treatment. The other eye served as control. Eyes were examined at 1, 24, 48, 72 h and 7 days after application.
Apart from hyperaemic vessels in the conjunctivae of one rabbit eye at one hour after application, which were resolved by 24 hours.
Since the observed effects were cleared within 24 hours, the chemical Octamethylcyclotetrasiloxane (CAS No: 556-67-2) was considered as not irritating to the eye of New Zealand White rabbits.
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