Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

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

There are no data available on the reproductive/developmental effects of Burnt Oil Shale or its main toxicologically relevant component crystalline silica via oral, dermal or inhalation exposures in animals and humans. For crystalline silica, this is in agreement with the notion of an insignificant bioavailability of these insoluble particles following exposure by either route, which is supported by the available data on the toxicokinetic behaviour of crystalline silica (see Chapter 7.1).

Inhalation is the most relevant route of human exposure for Burnt Oil Shale and crystalline silica. The whole body of available information on respirable crystalline silica indicates that potential toxic effects will mainly be restricted to the lung as target organ. Moreover, the numerous epidemiological studies conducted to address the toxicity of respirable crystalline silica in occupational settings provide no indications for potential adverse effects on reproduction/development (IARC, 1997; IPCS, 2000; NIOSH, 2000).

For amorphous silica, no reproductive/developmental effects were observed in a study carried out with female rats orally exposed at 500 mg/kg bw/day via the diet for 6 months. During this period, the animals were mated twice and allowed to breed. No effects were observed in the two litters as well (Lewinson et al., 1994). In other studies, a higher oral NOEL value (1600 mg/kg bw/day) for maternal and developmental toxicity has been reported for rat, mouse, hamster and rabbit mice (OECD SIDS, 2004).


Short description of key information:
There are no available data on the reproductive effects of Burnt Oil Shale or its main toxicologically relevant component crystalline silica in laboratory animals. There are no reports suggesting or indicating such effects in humans.

Effects on developmental toxicity

Description of key information
There are no available data on the developmental/teratogenic effects of Burnt Oil Shale or its main toxicologically relevant component crystalline silica in laboratory animals. There are no reports suggesting or indicating such effects in humans.
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

There are no data available on the reproductive/developmental effects of Burnt Oil Shale or its main toxicologically relevant component crystalline silica via oral, dermal or inhalation exposures in animals and humans. For crystalline silica, this is in agreement with the notion of an insignificant bioavailability of these insoluble particles following exposure by either route, which is supported by the available data on the toxicokinetic behaviour of crystalline silica (see Chapter 7.1).

Inhalation is the most relevant route of human exposure for Burnt Oil Shale and crystalline silica. The whole body of available information on respirable crystalline silica indicates that potential toxic effects will mainly be restricted to the lung as target organ. Moreover, the numerous epidemiological studies conducted to address the toxicity of respirable crystalline silica in occupational settings provide no indications for potential adverse effects on reproduction/development (IARC, 1997; IPCS, 2000; NIOSH, 2000).

For amorphous silica, no reproductive/developmental effects were observed in a study carried out with female rats orally exposed at 500 mg/kg bw/day via the diet for 6 months. During this period, the animals were mated twice and allowed to breed. No effects were observed in the two litters as well (Lewinson et al., 1994). In other studies, a higher oral NOEL value (1600 mg/kg bw/day) for maternal and developmental toxicity has been reported for rat, mouse, hamster and rabbit mice (OECD SIDS, 2004).

Justification for classification or non-classification

In conclusion, considering the physicochemical properties of Burnt Oil Shale, the toxicokinetic behaviour and toxicity of crystalline silica after inhalation as the relevant route of human exposure, and the indications from data on amorphous silica, no reproductive or developmental effects of Burnt Oil Shale is expected. Therefore Burnt Oil Shale has not to be classified for reproductive or developmental toxicity.