Fumes, silica

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A scientific review by authorative international body.

Principles of method if other than guideline:

OECD evaluated the available test data on synthetic amorphous silica.

GLP compliance:

no

Remarks:

Review - both yes and no

Species:

rabbit

Irritation parameter:

erythema score

Time point:

other: 24 hours

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: hydrophilic precipitated silica; slight erythemas in 4/6 animals

Irritant / corrosive response data:

The studies with synthetic amorphous shoved that silica were not irritating to the skin of a rabbit.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

OECD (2004) includes eight skin irritation studies, of which three were regarded as critical studies for SIDS endpoint. These three studies were conducted with hydrophilic pyrogenic or precipitated silica. None of the studies showed skin irritating effects.

Executive summary:

In OECD (2004), hydrophilic pyrogenic or precipitated silica were tested by exposing rabbits to 0.19 g or 0.5 g of dry or moistened test item under occlusive conditions for 4 or 24 hours. These synthetic amorphous silica were not irritating to skin under experimental conditions. However, these compounds may produce skin dryness following prolonged and repeated exposure.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A scientific review by authorative international body

Principles of method if other than guideline:

OECD evaluated the available test data on synthetic amorphous silica.

GLP compliance:

no

Remarks:

review: - both yes and no

Species:

rabbit

Irritation parameter:

conjunctivae score

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: hydrophilic precipitated silica; redness 2 after 1h, and 2 and 1 after 24 h; very slight chemosis and discharge after 1h

Irritation parameter:

conjunctivae score

Time point:

other: no data

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: hydrophilic precipitated silica

Irritant / corrosive response data:

The studies with synthetic amorphous silica did not cause eye irritation on rabbit.

Non of the studies in the review was showing eye irritation.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

OECD (2004) includes six eye irritation studies with synthetic amorphous silica, of which two were regarded as critical studies for SIDS endpoint. These two studies were conducted with hydrophilic precipitated silica. None of the studies showed eye irritating effects on rabbit.

Executive summary:

In OECD (2004), all synthetic amorphous silica products tested as a powder (0.1 g) have shown no or only weak and transient irritating effects on the conjunctivae of the eyes of rabbits with the iris and cornea not affected at all. In conclusion, synthetic amorphous silica are not irritating to eyes under experimental conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
In OECD (2004), hydrophilic pyrogenic or precipitated silica were tested by exposing rabbits to 0.19 g or 0.5 g of dry or moistened test item under occlusive conditions for 4 or 24 hours. These synthetic amorphous silica were not irritating to skin under experimental conditions. However, these compounds may produce skin dryness following prolonged and repeated exposure

Justification for selection of eye irritation endpoint:
In OECD (2004), all synthetic amorphous silica products tested as a powder (0.1 g) have shown no or only weak and transient irritating effects on the conjunctivae of the eyes of rabbits with the iris and cornea not affected at all. In conclusion, synthetic amorphous silica are not irritating to eyes under experimental conditions.

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