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EC number: 216-467-0 | CAS number: 1591-02-2
Endpoint summary
Administrative data
Description of key information
The assessment of skin irritation was conducted according to OECD TG 439 using both the EpiSkin and the EpiDerm protocols, which both concluded the test material to be not irritating to skin in vitro (BSL Bioservice, 2015b; 2015c).
The assessment of eye irritation was conducted according to OECD TG 437. The study determined the test item to be negative for eye irritation potential (BSL Bioservice, 2015d).
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation assessment was carried out in vitro according to OECD TG 439, using both the EpiSkin and EpiDerm protocols to ensure the validity of the result regarding the assessment of silicon based substances.
In the in vitro Human Skin Model Test (EPISKIN-SM™) conducted to OECD TG 439 and GLP, the mean relative tissue viability (% negative control) was >50% (88.4%) after 15 minutes treatment and 42 hours post incubation for dibutoxy(dimethyl)silane (BSL Bioservice, 2015b). According to the criteria upon which the interpretation is based, the result is negative for skin irritation. The mean absolute OD550 of the three negative control tissues was 0.6 and ≤ 1.5. The mean relative tissue viability (% negative control) of the positive control was 40% (15.7%). The maximum standard deviation of viability of replicate tissues of all dose groups was <18% (5.4% - 6.4%).The controls confirm the validity of the study.
A second in vitro study assessing skin irritation was also carried out, to confirm the validity of the irritation outcome of the first study using the EpiSkin method. In the in vitro Human Skin Model Test (EpiDermTM) conducted to OECD TG 439 and GLP, the mean relative tissue viability (% negative control) was >50% (116.5%) after 60 minutes of treatment and 42 hours post incubation for dibutoxy(dimethyl)silane (BSL Bioservice 2015c). According to the criteria upon which the interpretation is based, the
result is negative for skin irritation. The mean relative tissue viability (% negative control) was >50% (116.5%) after 60 minutes of treatment and 42 hours of post incubation. The mean absolute OD550 of the three negative control tissues was ≥0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was 20% (4.6%). The maximum standard deviation of viability of replicate tissues of all dose groups was <18% (0-5% - 12.0%).The controls confirm the validity of the study.
The in vitro Bovine Corneal Opacity and Permeability Assay (BCOP) for dibutoxy(dimethyl)silane was conducted according to OECD TG 437 and GLP (BSL Bioservice, 2015d). The study reports the mean in vitro irritation score (IVIS) of 2.51, derived from opacity and permeability values, following 10 min of exposure and 2 hours of post incubation. The result is negative for eye irritation potential, according to the current criteria for interpretation, where IVIS ≤3 = Non-corrosive (No category).
The in vitro eye irritation score obtained with the positive control fell within two standard deviations of the current historical mean and therefore the assay is considered to be valid. The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control (within two standard deviations of the current historical mean).
Justification for selection of skin irritation / corrosion endpoint:
The study was conducted according to OECD TG 439 and in compliance with GLP.
Justification for classification or non-classification
Based on the available in vitro data, no classification is required for skin or eye irritation in accordance with Regulation (EC) No. 1272/2008.
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