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EC number: 213-650-7
CAS number: 998-30-1
Skin irritation (OECD TG 404): Irritating Eye irritation (OCED TG 405): Irritating
Table 1. Results of skin
Mean value24 +48 + 72 h
Mean value24 +48 + 72 h,all animals
E: erythema, O: oedema (according to Draize Score)
Table 1. Ocular Irritation
No. with ocular reactions/ No. treated
0.1 ml/ right eye, unwashed
0.1 ml/ right eye, washed
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.
A key skin irritation study, conducted
in compliance with GLP and according to OECD TG 404, showed that
triethoxysilane induced moderate to slight erythema on two and one
rabbits, respectively. All rabbits had very slight oedema. Desquamation
was present in all rabbits by day 5. Dermal irritation subsided by day
14 in one animal. Desquamation persisted through day 14 in two rabbits.
Very slight erythema was present on day 14 in one animal. The primary
irritation index was calculated to be 3.1. Triethoxysilane produced
moderate dermal irritation under the conditions of this study and very
slight erythema which persisted until termination in a single animal
A limited report on skin irritation
was also available, which was not conducted according to guideline or in
compliance with GLP (reliability score 4). The application of the
undiluted test material on rabbit skin resulted in trace irritation
(Wacker, 1978). Furthermore, in the previously discussed acute dermal
toxicity study with triethoxysilane, severe erythema, moderate to severe
edema, fissuring, eschar and exfoliation was observed in all animals. In
addition, six rabbits had evident corrosive dermal effects, in addition
to a single occurrence of blanching. Desquamation was present on all
animals by day 5 and persisted throughout the remainder of the study.
There were no other dermal findings. Severe erythema and slight to
moderate edema persisted until study termination (day 14) in four
rabbits. Erythema was reduced to slight and very slight for five and one
animal, respectively, and edema had decreased to slight or very slight
for nine rabbits by study termination (DCC, 1995c). The results of all
three studies are in agreement and give evidence for the skin irritation
potential of triethoxysilane.
The key study for eye irritation which
was conducted in compliance with GLP and according to OECD TG 405,
showed that triethoxysilane induced moderate ocular irritation and
corneal and conjunctival irritation in the right eye of all animals and
positive iridal reactions for three and two, unwashed and washed rabbits
respectively. Iridial irritation had completely subsided by day 14 or
earlier for the unwashed group and by day 4 for the washed group.
Corneal irritation completely subsided by day 21 or earlier for all
washed animals and by day 14 or earlier for two of the unwashed animals.
Minor, reversible conjunctival redness persisted through day 21 for one
washed eye. Corneal opacity and minor conjunctival redness persisted
through day 28 (study termination) for one unwashed animal (DCC, 1995e).
Furthermore, a limited report of an eye irritation study without
guideline or GLP compliance (reliability score 4) on triethoxysilane,
reported severe corneal injury, with iritis, from 0.005 ml undiluted per
eye and from 0.5 ml per eye of a 15 % dilution in dimethyl phthalate
(DMP); minor corneal injury on 5 eyes from a 5 % dilution in DMP
(Wacker, 1978). The results of both experiments are in agreement and
give evidence for an eye irritation potential of triethoxysilane.
Justification for selection of skin irritation / corrosion
The key study was selected for assessment.
Justification for selection of eye irritation endpoint:
The key study was selected for assessment.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: corrosive
Based on the available study for skin
irritation, triethoxysilane needs to be classified as R38 ‘’Irritating
to skin’’ according to the criteria of EU Directive 67/548/EEC, and Skin
Irritant Category 2 under Regulation 1272/2008.
Based on the available study for eye
irritation, triethoxysilane needs to be classified as R41 ‘’Risk of
serious damage to eyes’’ according to the criteria of EU Directive
67/548/EEC, and Eye Irritant Category 1 under Regulation 1272/2008.
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