Registration Dossier

Administrative data

Endpoint:
long-term toxicity to birds
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
Please see the cross-referenced supporting information to justify the waiving of terrestrial toxicity data.
Further discussion on the ecotoxicity of silicic acid producers can be found in the attached report “PFA, 2013x Analogue report Ecotoxicity of (poly)silicic acid producers_20130516”.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Bioaccumulation: aquatic/sediment: Low potential for bioaccumulation

Testing is waived in accordance with Column 2 of REACH Annex IX. Direct or indirect exposure of aquatic organisms to the registered substance is very limited due to the instability of the substance in water. The substance hydrolyses very rapidly to monosilicic acid [Si(OH)4], hydrochloric acid and hydrogen.

Silicic acid condenses at concentrations above approximately 100-150 mg/L as SiO2 to give insoluble amorphous polysilicic acid. These hydrolysis products are inorganic substances which enter natural biogeochemical cycles.

Silicic acidis the bioavailable form of silica that can be absorbed by certain organisms in the environment. In these organisms, silicic acid, precipitated as insoluble amorphous silica, plays a structural and defensive role. In animals, silica is a trace nutrient.

Reason / purpose for cross-reference:
data waiving: supporting information
Reference

There are no in vivo or in vitro data on the toxicokinetics of trichlorosilane.

The following summary has therefore been prepared based on the physicochemical properties of the substance itself and its hydrolysis products. The main input variable for computer-based toxicokinetic prediction models is log Kow which is not relevant for inorganic substances such as trichlorolsilane.

Trichlorosilane is a moisture-sensitive, volatile liquid that hydrolyses very rapidly in contact with water (half-life approximately 5 seconds at pH 7), generating HCl and silicic acid; hydrogen gas is a further by-product of the hydrolysis reaction. At concentrations above about 100 -150 mg/l (measured as SiO2 equivalents), condensation products of monosilicic acid can also form. At concentrations >100 -150 mg/l of SiO2, monomeric monosilicic acid condenses into insoluble colloidal particles of polysilicic acid (silica sol) or a highly cross-linked network (silica gel). These forms of polysilicic acid are equivalent to synthetic amorphous silica. Most, if not all, hydrolysis will have occurred before absorption into the body, therefore relevant systemic exposure is limited to the hydrolysis products.

Human exposure can occur via the inhalation or dermal routes. Relevant inhalation exposure would be to the hydrolysis products (hydrolysis would occur rapidly when inhaled, even if a mixture of parent and hydrolysis products were present in air). The substance would also hydrolyse rapidly in contact with moist skin. The resulting HCl hydrolysis product would be severely irritating or corrosive.

Potential systemic exposure to hydrochloric acid is not discussed.

Absorption

Oral

Significant oral exposure is not expected for this corrosive substance.

However, oral exposure to humans via the environment may be relevant for the hydrolysis product, silicic acid and then silica. When oral exposure takes place, it is necessary to assume that except for the most extreme of insoluble substances, that uptake through intestinal walls into the blood takes place. Uptake from intestines can be assumed to be possible for all substances that have appreciable solubility in water or lipid. Other mechanisms by which substances can be absorbed in the gastrointestinal tract include the passage of small water-soluble molecules (molecular weight up to around 200) through aqueous pores or carriage of such molecules across membranes with the bulk passage of water (Renwick, 1993).

As silica is water soluble (approximately 100 - 150 mg SiO2/l with condensation occurring at higher concentrations) and has a molecular weight of approximately 60.08 g/mol it meets both of these criteria, so should oral exposure occur it is reasonable to assume systemic exposure will occur also. Gastrointestinal absorption of insoluble silica will be insignificant as compared to the absorption of the soluble species (Carlisle, 1986).

Dermal

Trichlorosilane hydrolyses rapidly on the skin, thus producing silicic acid and HCl. The molecular weights of the hydrolysis products favour absorption across the skin. However, silica is water soluble (approximately 100 - 150 mg SiO2/l with condensation occurring at higher concentrations), which suggests that it is too hydrophilic to cross the lipid rich stratum corneum.  Since the other hydrolysis product, HCl is corrosive to the skin, damage to the skin might increase penetration. Absorption of the insoluble condensation products is not expected.

Available dermal studies did not show evidence of systemic availability, as effects (such as those on body weights) are generally thought to be secondary to corrosion of the skin.

Inhalation

Inhalation exposure would be to the hydrolysis products as trichlorosilane would hydrolyse rapidly when inhaled, even if a mixture of parent and hydrolysis products were present in air. Once hydrolysis has occurred, significant uptake would be expected into the systemic circulation, as the silicic acid hydrolysis product is highly soluble (approximately 100 - 150 mg SiO2/l with condensation occurring at higher concentrations). Due to the hydrophilic nature of silicic acid, it is likely that some will be retained within the mucous of the lungs and thus absorption will be limited. Condensation to silica might lead to some precipitate being retained in the lining of the respiratory tract, although this cannot be confirmed from results of the only reliable experimental animal study available.

As with dermal exposure, damage to membranes caused by the corrosive nature of the hydrochloric acid hydrolysis product might enhance the uptake. In the available acute inhalation toxicity studies, the only adverse effects appeared to be secondary to corrosive effects of the test substance.

Distribution

All absorbed material is likely to be in the form of the hydrolysis products, HCl and silicic acid, which rapidly precipitates to insoluble silica (SiO2) when the concentration is sufficiently high. Silicic acid is a small molecule, and therefore has potential to be widely distributed, but its hydrophilic nature  will limit its diffusion across membranes (including the blood-brain and blood-testes barriers) and its accumulation in fatty tissues. Human blood contains 1 mg SiO2/l of monosilicic acid (Iler RK, 1979).  Hydrogen and chloride ions will enter the body’s natural homeostatic processes.

Metabolism

Trichlorosilane is rapidly hydrolysed to HCl and silicic acid, which rapidly precipitates to insoluble silica (SiO2) when the concentration is sufficiently high. Most if not all of this will have occurred before absorption into the body. Silicic acid is not metabolised, but forms a precipitate, as previously described. Silicon is an essential trace element participating in the normal metabolism of higher animals. It is required in bone, cartilage and connective tissue formation as well as participating in other important metabolic processes. The silicon is present almost entirely as free soluble monosilicic acid (Carlisle, 1986). Genetic toxicity tests in vitro showed no observable differences in effects with and without metabolic activation.

Excretion

A determinant of the extent of urinary excretion is the soluble fraction in blood. Given the hydrophilic nature of the hydrolysis product, silicic acid, the soluble fraction of silicic acid in blood is extremely high suggesting it is likely to be effectively eliminated via the kidneys in urine and accumulation is very unlikely.

Following oral ingestion precipitated silica will be eliminated in faeces. The low molecular weight and high water solubility of silicic acid suggest that it is likely to be rapidly eliminated via the kidneys in urine. There is therefore no evidence to suggest that this substance will accumulate in the body.

References

Renwick A. G. (1993) Data-derived safety factors for the evaluation of food additives and environmental contaminants. Fd. Addit. Contam. 10: 275-305.

Iler, Ralph K. (1979) The Chemistry of Silica: Solubility, Polymerization, Colloid and Surface Properties and Biochemistry of Silica, Wiley, p. 13.

Carlisle EM. Silicon as an essential trace element in animal nutrition. Ciba Found Symp. 1986;121:123-39.

Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.9 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL derivation method:
other: Assessment based on the IOEL for hydrochloric acid (8 mg/m3 (8 h TWA) in Commission Directive 2000/39/EC).
Overall assessment factor (AF):
1
Dose descriptor:
other: IOEL
AF for dose response relationship:
1
Justification:
Not required as assessment based on OEL.
AF for differences in duration of exposure:
1
Justification:
Not required as assessment based on OEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as assessment based on OEL.
AF for other interspecies differences:
1
Justification:
Not required as assessment based on OEL.
AF for intraspecies differences:
1
Justification:
Not required as assessment based on OEL.
AF for the quality of the whole database:
1
Justification:
Not required as assessment based on OEL.
AF for remaining uncertainties:
1
Justification:
Not required as assessment based on OEL.
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18.6 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL derivation method:
other: based on 15-minute STEL for HCl
Overall assessment factor (AF):
1
AF for dose response relationship:
1
Justification:
Based on 15-minute STEL for HCl
AF for interspecies differences (allometric scaling):
1
Justification:
Based on 15-minute STEL for HCl
AF for other interspecies differences:
1
Justification:
Based on 15-minute STEL for HCl
AF for intraspecies differences:
1
Justification:
Based on 15-minute STEL for HCl
AF for the quality of the whole database:
1
Justification:
Based on 15-minute STEL for HCl
Justification:
Based on 15-minute STEL for HCl
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Hazard assessment conclusion:
high hazard (no threshold derived)
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified
Hazard assessment conclusion:
no hazard identified

There are no consumer uses of trichlorosilane, therefore it is not possible for the local effects caused by the hydrolysis product, HCl, to occur. In the case of exposure via the environment, trichlorosilane does not exist due to rapid hydrolysis to HCl and monosilicic acid. Exposure of the general population could potentially be to condensed monosilicic acid, polysilicic acid (SAS), for which a 90-day oral repeated dose, reproductive and developmental toxicity studies are available to show that adverse systemic effects are not expected. Hence, the overall conclusion 'no hazard identified' for the general population for all routes and durations of exposure. It is also of note that monosilicic acid and polysilicic acid are naturally occurring substances which are ubiquitous in the environment.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion