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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
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 secondary source.

Data source

Reference
Reference Type:
secondary source
Title:
SIDS Initial Assessment Report for SILICIC ACID, ETHYL ESTER
Author:
OECD SIDS
Year:
2010
Bibliographic source:
SIDS Initial Assessment Report for SILICIC ACID, ETHYL ESTER, OECD SIDS, last updated 2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Buehler test was performed to assess the dermal sensitization potential of the test chemical
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid, ethyl ester
EC Number:
234-324-0
EC Name:
Silicic acid, ethyl ester
Cas Number:
11099-06-2
Molecular formula:
C2 H6 O.x-Unspecified
IUPAC Name:
Silicic acid, ethyl ester
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Silicic acid, ethyl ester
- IUPAC name: ethoxy(oxo)silanol
- Molecular formula: C2H6O.x-Unspecified
- Molecular weight: 208.328 g/mol
- Smiles notation: [Si](OCC)(OCC)(OCC)OCC
- Substance type: Organic
- Physical state: liquid (clear colourless solution)

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
iNDUCTION I- undiluted
INDUCTION II- undiluted
INDUCTION III- undiluted
Day(s)/duration:
No data available
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: MEH 56 corn oil
Concentration / amount:
50% test chemical in MEH 56 corn oil
Day(s)/duration:
No data available
Adequacy of challenge:
not specified
No. of animals per dose:
Total:30
Test group:20
control :10
Details on study design:
Details on study design
RANGE FINDING TESTS: Pretests were conducted to determine the dose levels used in induction and challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available
- Frequency of applications: No data available
- Duration: No data available
- Concentrations: undiluted

B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: No data available
- Exposure period: No data available
- Test groups:20
- Control group:10
- Site: No data available
- Concentrations: 50% test chemical in MEH 56 corn oil
- Evaluation (hr after challenge):
Challenge controls:
Yes
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Key result
Reading:
other: Challenge
Group:
test chemical
Dose level:
50% test chemical in MEH 56 corn oi
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
Skin irritation was not observed in the control or test chemical-treated animals in Induction Phase III or at challenge. 
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitizing
Conclusions:
In the test chemical treated animals, very light erythema and edema was observed in 2 of 10 treated animals during Induction Phase I, and in 3 of 10 animals in Induction Phase II; no skin irritation was observed in the control animals. Skin irritation was not observed in the control or test chemical-treated animals in Induction Phase III or at challenge. 
Hence, the test chemical was considered to be not sensitizing to skin.
Executive summary:

Buehler test was performed to assess the dermal sensitization potential of the test chemical. The study was performed according to OECD 406 Guidelines.Pretests were conducted to determine the dose levels used in induction and challenge. A group of guinea pigs (strain not specified; 10 control animals and 20 treated animals in each study) were induced twice with undiluted occlusive epicutaneous exposures to the test chemical. They were induced for the third time, and challenged, with an occlusive epicutaneous exposure to 50% test chemical in MEH 56 corn oil.

In the test chemical treated animals, very light erythema and edema was observed in 2 of 10 treated animals during Induction Phase I, and in 3 of 10 animals in Induction Phase II; no skin irritation was observed in the control animals. Skin irritation was not observed in the control or test chemical-treated animals in Induction Phase III or at challenge. 

Hence, the test chemical was considered to be not sensitizing to skin.