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EC number: 213-650-7
CAS number: 998-30-1
Table 1. Incidence of dermal response – Challenge phase
Number of animals
5% Triethoxysilane in cottonseed oil
100% cotton seed oil
5% Triethoxysilane in cotton seed oil
0.1% DNCB in 80% Ethanol
Table 2. Incidence of dermal response – rechallenge phase.
1% Triethoxysilane in cotton seed oil
Challenge phase result:
The 5% concentration of Triethoxysilane induced six moderate and
fourteen mild reactions at 24 hours post-challenge in the test group.
Thirteen mild reactions were noted for the same animals at 48 hours.
Vehicle (cotton seed oil) control sites on the test group animals had
nineteen and eleven mild reactions at 24 and 48 hours, respectively.
For the negative control-I group animals, the 5% Triethoxysilane
concentration induced five moderate and five mild reactions at 24 hours
post-challenge. At 48 hours, eight mild reactions at the test material
dosed sites were noted. Vehicle dosed sites had eight and three mild
reactions reported at 24 and 48 hours, respectively.
In the positive control group, three severe (grade 3) reactions and
seven moderate reactions were observed at 24 hours at the DNCB dosed
sites. At 48 hours, six severe, four moderate reactions and five eschar
formations were noted. The positive control group guinea pigs had seven
and one mild reactions at 24 and 48 hours, respectively, for vehicle (80
% ethanol) treated sites.
The 1 % concentration of Triethoxysilane induced five moderate and
fifteen mild reactions for test group animals at 24 hours. Two moderate
and sixteen mild reactions were noted for the same animals at 48 hours.
Vehicle (cotton seed oil) control sites for the test group animals had
twenty and fourteen mild reactions at 24 and 48 hours, respectively.
The negative control-II group guinea pigs had three moderate and six
mild reactions for test material dosed at 24 hours. At 48 hours, eight
mild reactions at the test material dosed sites were observed. Vehicle
(cotton seed oil) dosed sites had nine and seven mild reactions at 24
and 48 hours, respectively. The sensitisation index
was calculated to be 0 % (0/20) for the test group following challenge
and rechallenge dosing. The sensitisation index was 100% (10/10) for the
Signs of irritation were noted during the induction. The macroscopic and
histopathological examinations did not reveal any lesion of delayed
hypersensitivity in the 20 treated animals. No noticeable cutaneous
abnormality was noted in the 20 guinea pigs examined in the control
Studies were chosen as key when the
available study was of relevance and of sufficient quality for
classification, labelling and for risk assessment.Other available data
are included as supporting studies.
In a key guinea pig maximisation test
conducted in compliance with GLP and according to OECD TG 406,
triethoxysilane was found to be a non-sensitiser (DCC 1995f). The
sensitisation index was calculated to be 0% for the test group following
challenge and rechallenge. However, challenge
and re-challenge with the test substance caused the same grade of
irritation in both the test group and the control group. A
non-irritating challenge concentration as required by the guideline OECD
406 was not identified. Based on the results of the study the authors
concluded that triethoxysilane has no sensitising potential, due to the
fact that no difference in irritation was observed among the groups.
A group of ten male and female guinea
pigs was dosed with multiple intradermal injections on day 0 following a
topical application on day 7 in order to investigate sensitisation
potential of triethoxysilane. The
topical induction consisted of a 48 hour occluded dermal exposure to 50
% triethoxysilane. Fourteen days after topical induction, challenge
dosing for detection of sensitisation was performed. For challenge
dosing, an essentially non-irritating concentration (5%) of the test
material was applied under occlusion for 24 hours. One week after
challenge dosing, test groups animals were rechallenged and the initial
challenge results were confirmed. The positive control vehicle, 80%
ethanol, was demonstrated to be essentially non-irritating under the
conditions of this study.
A key skin sensitisation study is also
available on the structural analogue substance triethoxy(methyl)silane
(CAS: 2031-67-6). Both of these substances hydrolyse to produce
structurally similar silanol hydrolysis products, methylsilanetriol and
silantriol, and are therefore deemed to be sufficient for read-across.
In a guinea pig maximisation test conducted
in compliance with GLP and according to OECD TG 406, the structural
analogue substance triethoxy(methyl)silane was found to be a
non-sensitiser. The sensitisation index was calculated to be 0% for the
test group following challenge. A group of ten male and ten female
guinea pigs was dosed with multiple intradermal injections on day 0
following a topical application on day 7 to induce a possible sensitised
state for evaluation for delayed contact hypersensitivity.
The topical induction consisted of a 48 hour
occluded dermal exposure to 0.5 ml of the test substance in a 50% (v/v)
solution in sterile codex liquid paraffin. Eleven days after topical
induction, challenge dosing for detection of sensitisation was
performed. For challenge dosing, an essentially non-irritating
concentration (10% (v/v)) of the test material was applied under
occlusion for 24 hours. The test material vehicle, sterile codex liquid
paraffin, was also found to be non-sensitising under the conditions of
this study (Hazelton France, 1992). The results of both experiments are
in agreement with the lack of skin sensitisation potential of the
The available data on skin sensitisation of
the registered substance and the structural analogue substance
triethoxy(methyl)silane (CAS: 2031 -67 -6) do not meet the criteria for
classification according to Regulation 1272/2008 or EU Directive
67/548/EEC, and are therefore conclusive but not sufficient for
classification of the registered substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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