Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no oral, inhalation or dermal reproductive toxicity studies available for dichloro(diphenyl)silane. Data waivers are in place for this endpoint (see attachment to data waiver for toxicity to reproduction).

Limited data are available regarding the reproduction and development of animals following oral, dermal or inhalation exposure to hydrogen chloride or hydrochloric acid, however, protons and chloride ions both exist as normal constituents of body fluid in animals, hence low concentrations of hydrogen chloride appear not to cause adverse effects in animals. Therefore hydrochloric acid would not contribute to any reproductive toxicity (fertility or developmental) effects at the dose levels tested.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Effect on fertility via oral route:
Dichloro(diphenyl)silane (CAS 80-10-4) is a highly moisture-sensitive liquid that hydrolyses rapidly in contact with water (measured half-life of 6 to 10 seconds at pH 4, 7 and 9 at 1.5°C) to diphenylsilanediol and hydrogen chloride (HCl). As the substance is corrosive, risk management measures are in place at industrial sites to prevent the potential for human exposure to dichloro(diphenyl)silane. Due to the corrosive nature of the substance it is considered not to be either ethical or scientifically justified to perform repeated dose toxicity testing with dichloro(diphenyl)silane by any route of exposure. As an example, following repeated oral dosing, the corrosive nature of the product could affect the lining of the stomach, giving rise to hyperplasia and a subsequent reduced food intake. This would make the interpretation of any systemic findings difficult.

A 7-day dose-range-finding (DRF) study with trichloro(propyl)silane (CAS 141-57-1) is in progress, with an expected completion date of 30thJune 2017. A decision on whether a 28-day DRF study with trichloro(propyl)silane is scientifically justified will be based on the extent of corrosion observed in the on-going 7-day study. This stepwise approach is being used to investigate the corrosive effects of trichloro(propyl)silane, which is representative of other registered chlorosilanes, following repeated oral gavage administration to rats. The results of the 7-day DRF (and possibly the 28-day DRF) study with trichloro(propyl)silane and consideration of HCl release will form the basis of the justification for testing/not testing this and other chlorosilanes, in full higher tier studies

Effect on fertility via inhalation route:
A guideline-compliant repeated-dose inhalation study should elicit systemic toxicity at the highest test concentration. Since the local corrosive effects of dichloro(diphenyl)silane would be significant, it is unlikely that any systemic effects would be seen at dose levels made sufficiently low (< 10 ppm) to prevent the known corrosive effects and/or distress in the test species.

Effect on fertility via dermal route:
In accordance with Section 2 of REACH Annex XI testing for reproductive toxicity (required in Section 8.7.3) will be omitted because it is technically not feasible.
The known corrosive effects of Dichloro(diphenyl)silane mean that testing via all routes at suitable dose levels would lead to severe local effects and significant distress in the test species.

Effects on developmental toxicity

Description of key information

There are no oral, inhalation or dermal developmental toxicity studies available for dichloro(methyl)(phenyl)silane. Data waivers are in place for this endpoint (see attachment to data waiver for developmental toxicity).

Limited data are available regarding the reproduction and development of animals following oral, dermal or inhalation exposure to hydrogen chloride or hydrochloric acid, however, protons and chloride ions both exist as normal constituents of body fluid in animals, hence low concentrations of hydrogen chloride appear not to cause adverse effects in animals. Therefore hydrochloric acid would not contribute to any reproductive toxicity (fertility or developmental) effects at the dose levels tested.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Effect on developmental toxicity: via oral route:
Dichloro(diphenyl)silane (CAS 80-10-4) is a highly moisture-sensitive liquid that hydrolyses rapidly in contact with water (measured half-life of 6 to 10 seconds at pH 4, 7 and 9 at 1.5°C) to diphenylsilanediol and hydrogen chloride (HCl). As the substance is corrosive, risk management measures are in place at industrial sites to prevent the potential for human exposure to dichloro(diphenyl)silane. Due to the corrosive nature of the substance it is considered not to be either ethical or scientifically justified to perform repeated dose toxicity testing with dichloro(diphenyl)silane by any route of exposure. As an example, following repeated oral dosing, the corrosive nature of the product could affect the lining of the stomach, giving rise to hyperplasia and a subsequent reduced food intake. This would make the interpretation of any systemic findings difficult.

A 7-day dose-range-finding (DRF) study with trichloro(propyl)silane (CAS 141-57-1) is in progress, with an expected completion date of 30thJune 2017. A decision on whether a 28-day DRF study with trichloro(propyl)silane is scientifically justified will be based on the extent of corrosion observed in the on-going 7-day study. This stepwise approach is being used to investigate the corrosive effects of trichloro(propyl)silane, which is representative of other registered chlorosilanes, following repeated oral gavage administration to rats. The results of the 7-day DRF (and possibly the 28-day DRF) study with trichloro(propyl)silane and consideration of HCl release will form the basis of the justification for testing/not testing this and other chlorosilanes, in full higher tier studies

Effect on developmental toxicity: via inhalation route:
A guideline-compliant repeated-dose inhalation study should elicit systemic toxicity at the highest test concentration. Since the local corrosive effects of dichloro(diphenyl)silane would be significant, it is unlikely that any systemic effects would be seen at dose levels made sufficiently low (< 10 ppm) to prevent the known corrosive effects and/or distress in the test species.

Effect on developmental toxicity: via dermal route:
In accordance with Section 2 of REACH Annex XI testing for developmental toxicity (required in Section 8.7.2) will be omitted because it is technically not feasible.
The known corrosive effects of Dichloro(diphenyl)silane mean that testing via all routes at suitable dose levels would lead to severe local effects and significant distress in the test species.

Justification for classification or non-classification

In the absence of appropriate measured data, the substance is not classified for reproductive or developmental toxicity.