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Administrative data

Description of key information

The key skin irritation/corrosion study (Dow Corning 1980) involved the repeated application of the neat test material (under semi-occluded conditions) to the abraded and intact skin of one rabbit for 10 days (excluding weekends). This study does not conform to the standard guideline (OECD 404), and did not follow GLP, but would be anticipated to present conditions that were more stringent than the standard guideline. This study reported only slight redness following this treatment but gave no details of graded skin reactions. The neat test material was judged to be non-irritant.
The key eye irritation/corrosion study (Dow Corning 1980) was conducted broadly in accordance with the standard guideline (OECD 405) but without retaining one untreated eye as control, using a smaller number of animals than recommended and without GLP compliance. No irritation was observed but no details of graded ocular reactions were given. The neat test material was judged to be non-irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

The key study for skin and eye irritation (DCC, 1980)

indicates that D3 is not irritant to skin or eyes. However, the study has recently been re-assessed and is not considered to be of high enough quality to be assigned Reliability 1 or 2, as many criteria of current test guidelines are not met.

This is the only available study covering these endpoints. No suitable read-across data are available. Therefore, the opinion of the ECHA is sought on the best way forward; further testing may be necessary.

Justification for classification or non-classification

The available data do not support classification for skin or eye irritation or corrosion (Regulation (EC) No 1272/2008; Directive 67/548/EEC).