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Toxicological information

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Administrative data

Description of key information

The key study for skin sensitisation reported 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not to be sensitising to guinea pig skin in a guinea pig maximisation test, which was conducted according to OECD TG 406 and in compliance with GLP (Dow Corning Corporation, 1997).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
19 not 20 animals tested
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.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation:
Range-finding: Intradermal: approximately 4 weeks at time of dosing; Topical: 11-12 weeks at time of dosing
Sensitisation study: 5-6 weeks
- Weight at study initiation: males: 347-460 g; females: 312-412 g
- Housing: individually in suspended stainless steel cages with wire mesh bottoms
- Diet (e.g. ad libitum): Agway Prolab Purina Guinea Pig Diet and Certified guinea pig diet no. 5026. ad libitum
- Water (e.g. ad libitum): water provided by watering system
- Acclimation period:
Range-finding animals: 22 or 57 days
Sensitisation animals: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24°C
- Humidity (%): 17-62%
- Air changes (per hr): 12.2-22.1
- Photoperiod (hrs dark / hrs light): 12/12
Route:
intradermal and epicutaneous
Vehicle:
other: mineral oil
Concentration / amount:
Range-finding:
Intradermal: 0.1 ml 5% v/v
Topical: 0.1 ml 25, 50, 75, 100% v/v
Intradermal induction:
5% v/v
Topical induction:
100% v/v
Challenge:
100% v/v
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: mineral oil
Concentration / amount:
Range-finding:
Intradermal: 0.1 ml 5% v/v
Topical: 0.1 ml 25, 50, 75, 100% v/v
Intradermal induction:
5% v/v
Topical induction:
100% v/v
Challenge:
100% v/v
No. of animals per dose:
Range-finding: 4 males, 4 females
Sensitisation study: 20 males, 20 females
Irritation controls: challenge: 15 males, 15 females
Details on study design:
RANGE FINDING TESTS: Based on the preliminary intradermal and topical applications, a 5% suspension was found to be the optimal concentration for the intradermal induction, undiluted (100%) for the topical induction, and undiluted (100% for the challenge).

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: Day 1 and Day 8
- Test groups: The area that had received the intradermal injections was preteated with 10% SLS in petrolatum (0.1 g/g (10w/v)) on day 7 to induce dermal irritation. The hair was re-clipped on day 8. Approximately 0.2 ml of the test solution was applied topically to the test site.
On day 8 neat test substance was applied topically over the six injection sites of each test substance treated animal.
- Control group: Approximately 0.2 ml of the controls were applied topically to the test site.
- Site: area over shoulder region
- Duration: 48 hours

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Test groups: 0.1 ml of the test substance was applied to the clipped right flank.
- Control group: 0.1 ml of the positive or irritation control was applied to the clipped right and left flanks.
- Site: right and left flank
- Evaluation (hr after challenge): 24 and 48 hours following removal of the patches.
Positive control substance(s):
yes
Remarks:
Hexylcinnamic aldehyde (HCA)
Positive control results:
One positive control animal was found dead on day 26. Postmortem examination revealed tan areas in the liver.
At sites treated with 100% HCA, 8/10 animals exhibited clear dermal responses at Challenge to a non-irritating concentration. 1/10 animals exhibited clear dermal response at the sites treated with 50% HCA. The Incidence Index of Sensitisation to 100% HCA was 80% and the Severity Indices at 24 and 48 hours were 1.1 and 0.8 respectively, compared to indices of 0.2 and 0.1 respectively in the irritation control animals.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100%
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:
100%
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:
other: irritation control (mineral oil)
Dose level:
100%
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:
other: irritation control (mineral oil)
Dose level:
100%
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:
100%
No. with + reactions:
8
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:
100%
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
50%
No. with + reactions:
1
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
other: irritation control (HCA)
Dose level:
100%
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:
other: irritation control (HCA)
Dose level:
100%
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:
other: irritation control (HCA)
Dose level:
50%
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:
other: irritation control (HCA)
Dose level:
50%
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:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
19
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
other: irritation control (1,2-bis-(Triethoxysilyl)-ethane)
Dose level:
100%
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:
other: irritation control (1,2-bis-(Triethoxysilyl)-ethane)
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
4,4,7,7-Tetraethoxy-3,8-dioxa-4,7-disiladecane is reported to not be sensitising to guinea pig skin in a GPMT study, which was conducted according to OECD TG 406 and in compliance with GLP.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The key study for skin sensitisation reports 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane not to be sensitising to guinea pig skin in a guinea pig maximisation test, which was conducted according to OECD TG 406 and in compliance with GLP (Dow Corning Corporation, 1997). Both the induction and challenge used a 100% concentration, which was administered to guinea pig skin. No dermal reactions were evident in any of the test animals (0/19), and the positive and negative controls had appropriate reactions.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information for 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane, no classification is required for skin sensitisation in accordance with Regulation (EC) No. 1272/2008.