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EC number: 915-748-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 19 September 2000 to 21 October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- 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:
- Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- EC Number:
- 915-673-4
- Cas Number:
- 211519-85-6
- Molecular formula:
- C18H42O6SxSi2
- IUPAC Name:
- Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- Reference substance name:
- 606-716-5
- EC Number:
- 606-716-5
- IUPAC Name:
- 606-716-5
- Reference substance name:
- Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
- IUPAC Name:
- Reaction mass of 4,4,15,15-tetraethoxy-3,16-dioxa-8,9,10,11-tetrathia-4,15-disilaoctadecane and 4,4,14,14-tetraethoxy-3,15-dioxa-8,9,10-trithia-4,14-disilaheptadecane and 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley [Crl:(HA)BR]
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Labs, Raleigh, NC, USA
- Age at study initiation: young adults
- Weight at study initiation: 291-339 g (males); 285-315 g (females)
- Housing: 1/suspended wire-mesh cage
- Diet: standard ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 67-73° F
- Humidity (%): 34-69
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: 2000-09-19 To: 2000-10-21
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- intradermal induction: 5% in ethanol; 5% in 1:1 FCA:saline
topical induction: neat (100%)
topical challenge: 25% in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- intradermal induction: 5% in ethanol; 5% in 1:1 FCA:saline
topical induction: neat (100%)
topical challenge: 25% in ethanol
- No. of animals per dose:
- test: 10/sex
positive control: 5/sex
negative control: 5/sex - Details on study design:
- RANGE FINDING TESTS:
primary irritation phase: intradermal (2/sex) 1, 3, 5% tested in mineral oil and 1:1 FCA:saline; topical (4/sex) 2.5, 5, 10, 25, 50% in ethanol and 100%
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal-3 paired injections, topical)
- Exposure period: topical 48h
- Test groups: 10/sex
- Control group: positive 5/sex; negative 5/sex
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations:
intradermal: 1:1 FCA saline; 5% TS in ethanol; 5% TS in 1:1 FCA:saline
topical: 100% TS
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 22
- Exposure period: 24h
- Test groups: 10/sex
- Control group: positive 5/sex; negative 5/sex
- Site: flank
- Concentrations: 25% TS in ethanol
- Evaluation (hr after challenge): 24 and 48 h following patch removal - Challenge controls:
- negative control: 25% TS in ethanol
positive control: 10% HCA (alpha-hexylcinnamaldeyde) in acetone - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldeyde
Results and discussion
- Positive control results:
- See table 1.
Based on the incidence index of 100%, the positive control material (HCA) was judged to be a sensitising agent under the conditions of this study.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% TS
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Dermal scores of 1 were reported in the negative control group. Scores >1 in the test group were judged to indicate sensitization.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% TS
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- Dermal scores of 1 were reported in the negative control group. Scores >1 in the test group were judged to indicate sensitization.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- ethanol, 0.3 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- ethanol, 0.3 ml/site
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 10% solution of hexacinnamaldehyde
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 10% hexacinnamaldehyde
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Table 1: Incidence of dermal response to challenge dosing
GROUP |
MATERIAL |
INTERVAL |
DERMAL SCORES* |
NO. ANIMALS |
SENSITIZATION INCIDENCE INDEX** |
SEVERITY INDEX*** |
|||
0 |
1 |
2 |
3 |
||||||
Test |
TS |
24h |
3 |
16 |
1 |
0 |
20 |
1/20=5% |
18/20=0.9 |
48h |
7 |
12 |
1 |
0 |
20 |
14/20=0.7 |
|||
vehicle |
24h |
20 |
0 |
0 |
0 |
20 |
0/20=0% |
0 |
|
48h |
20 |
0 |
0 |
0 |
20 |
0 |
|||
Positive control |
HCA in vehicle |
24h |
0 |
7 |
3 |
0 |
10 |
10/10=100% |
13/10=1.3 |
48h |
3 |
6 |
1 |
0 |
10 |
8/10=0.8 |
|||
vehicle |
24h |
10 |
0 |
0 |
0 |
10 |
0/10=0% |
0 |
|
48h |
10 |
0 |
0 |
0 |
10 |
0 |
|||
Negative control |
TS |
24h |
5 |
5 |
0 |
0 |
10 |
n/a |
5/10=0.5 |
48h |
9 |
1 |
0 |
0 |
10 |
1/10=0.1 |
|||
vehicle |
24h |
10 |
0 |
0 |
0 |
10 |
n/a |
0 |
|
48h |
10 |
0 |
0 |
0 |
10 |
0 |
|||
*Skin reactions were graded:
0 no reaction or very slight dispersed redness. No swelling.
1 slight patchy or confluent erythema
2 moderate and confluent erythema and/or slight swelling
3 severe erythema and/or moderate to severe swelling
** Sensitization incidence index: number of animals with dermal scores greater than those of the negative control group at 24h or 48h, divided by the number of animals tested. Grades of 1 or greater are considered indicative of sensitization in the positive control group
*** Severity index: the sum of test grades divided by the number of animals tested (given for 24h and 48h observations separately)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported guinea-pig maximization test identified a sensitization index of 5%. EU criteria for sensitization by skin contact would require a positive response in at least 30% of the test group.
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