Registration Dossier

Administrative data

Description of key information

The key skin irritation/corrosion study (ASTA Medica AG, 1996), conducted in accordance with OECD 404 with minor deviations found the test material to be slightly irritating to rabbit skin.  In a study conducted in accordance with the guideline (WIL, 2000), a similar test substance which contained a higher proportion of an S3 isomer  was found to be non-irritant.  

The key eye irritation/corrosion study (ASTA Medica, 1996), conducted in accordance with the standard guideline found the test material to be not irritating to the eyes of rabbits. In a study conducted in accordance with the guideline (WIL, 2000), a similar test substance which contained a higher proportion of an S3 isomer  was found 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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The key study for skin irritation, conducted in accordance with OECD 404 and GLP but using an occlusive dressing, found the test material to be slightly irritating (PII 1.5) based on readings at 1, 24, 48 and 72 h (ASTA Medica 1996). This result would be judged to be not irritating according to EU criteria. It is possible that the use of a semi-occlusive dressing might reduce irritation.

A supporting study was also available for skin irritation, conducted according to an appropriate OECD test guideline, and in compliance with GLP (WIL 2000). The test material was similar to the registered substance but contained a higher proportion of an S3 isomer. The test material was found to be not irritating to the skin of rabbits.

The key study for eye irritation, conducted in accordance with the standard guideline and GLP found the test material to be not irritating to the eyes of rabbits (ASTA Medica 1996).

A supporting study was also available for eye irritation, conducted according to an appropriate OECD test guideline, and in compliance with GLP (WIL 2000).The test material was similar to the registered substance but contained a higher proportion of an S3 isomer.

The substance in the read across studies with Low purity S2 contained approximately 65% of the registered substance. The other constituents are the structurally similar S1 and S3. Due to their structural similarity and similar physicochemical properties, the read-across substances are considered to be representative of the registered substance. See discussion in the reproductive toxicity section endpoint summary (Section 7.8, CSR section 5.9) for a more detailed justification for read-across approach.



Justification for classification or non-classification

Based on the available data, 4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane does not require classification for irritation according to Regulation (EC) 1272/2008.