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Registration Dossier
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EC number: 200-899-1 | CAS number: 75-76-3
Endpoint summary
Administrative data
Description of key information
In the key in vivo (non-LLNA) skin sensitisation study, conducted in accordance with OECD Test Guideline 406 (Buehler method) and in compliance with GLP, tetramethylsilane (CAS No. 75 -76 -3, EC No. 200-899 -1) was not sensitising in the guinea pig (Hüls, 1998e, reliability score 1).
As per the ECHA Endpoint Specific guidance (Chapter R.7a, version 6, July 2017), existing data of good quality that were generated before 10 May 2017, or for which the study was initiated before 10 May 2017, can be used to address the skin sensitisation endpoint. Reliable data were available from the OECD 406 Test Guideline study for tetramethylsilane and therefore additional in vitro testing for this endpoint is not required.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.11.1997 to 25.06.1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler 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:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmnH
- Age at study initiation: 'young'
- Weight at study initiation: <500 g
- Housing: Maximum five animals in conventional Type IV Makrolon cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: Preliminary study: from: 18.11.1997 to 21.11.1997. Main study: from: 26.05.1998 to 25.06.1998 - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction and challenge phases: undiluted test substance.
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction and challenge phases: undiluted test substance.
- No. of animals per dose:
- 20 test animals, 10 control.
- Details on study design:
- RANGE FINDING TESTS: 0.3cm3 of each of the test substance concentrations 5, 25, 50% (in corn oil) and undiluted test substance were applied to patches of surgical gauze. These were placed on the clipped flanks of each of three animals. The patches were covered with occlusive plaster and left in place for six hours. Each animal recieved two patches on each flank. After removal of the patch, residual test substance was cleared away using corn oil The dermal reactions were assessed 30 and 54 hours after the start of treatment. In the 4th week of the test, three guinea-pigs,kept under the same conditions, but without treatment, were used to re-determine the maximum non-irritant concentration for the challenge treatment. This additional determination was conducted because it was suspected that the sensitivity of the skin changed as the weight of the animals increased. In this test, the concentration administered and the experimental conditions were the same as those of the preliminary test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Left flank
- Frequency of applications: Weekly
- Duration: 28 days from first induction to challenge exposure
- Concentrations: Undiluted test substance
B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Day 28
- Exposure period: Six hours
- Test groups: Undiluted test substance
- Control group: Corn oil only
- Site: Right flank
- Concentrations: Undiluted test substance
- Evaluation (hr after challenge): 24 and 48 hours after removal of patches. - Challenge controls:
- Corn oil
- Positive control substance(s):
- yes
- Remarks:
- α-cinnamaldehyde. The most recent reliability check was performed in November/December 1997
- Positive control results:
- No positive control.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- undiluted test substance
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- undiluted corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- negative control
- Dose level:
- undiluted corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No significant treatment-related observations.
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- Sensitivity of the test species to positive controls was checked between 24/11/1997 and 24/12/1997 using α-hexylcinnamaldehyde and the Buehler Method; 50% of the test group showed evidence of delayed contact hypersensitivity.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a well conducted skin sensitisation study conducted to OECD 406 (Buehler method) and GLP (reliability score 1) tetramethylsilane was not sensitising to the skin of guinea-pigs.
- Executive summary:
In a well conducted skin sensitisation study conducted to OECD 406 (Buehler method) and GLP (reliability score 1) tetramethylsilane was not sensitising to the skin of guinea-pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the key sensitisation test, conducted according to OECD Test Guideline 406 and in compliance with GLP (Hüls, 1998, reliability score 1), female guinea pigs (20 test item and 10 controls) and 3 animals in an accompanying group were exposed to 100% of the test item under occlusive conditions for 6 hours. Thirty and fifty hours after challenge treatment, all skin reactions were observed and recorded according to the Magnusson and Kligman grading scale for evaluation of challenge patch test reaction. The undiluted test substance did not cause any skin irritations in a preliminary study. The 100% test compound was used for the induction period.
During the test, no systemic effects and no impairment of body weight gain due to the test substance were observed in the test and control animals. Thirty hours after all three inductions the dermal treatment with the test substance did not cause any skin reactions in the test animals. The control animals treated with the vehicle during the induction periods also showed no signs of skin irritation 30 hours post application. The challenge treatment with the undiluted test compound did not cause any cutaneous reactions on the posterior right flank of any animal in the test and control groups 30 and 54 hours after administration. The vehicle-laden patch did not lead to skin reactions in any animal of the test and control groups. Therefore, the test substance was considered not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on a reliable in vivo study, tetramethylsilane is not classified as a skin sensitiser according to Regulation (EC) No 1272/2008.
There are no data to suggest that tetramethylsilane is a respiratory sensitiser.
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