Registration Dossier

Administrative data

Description of key information

The key skin irritation/corrosion study (Notox, 1999, No. 262608), conducted according to OECD 404 and GLP, found the neat material to be non-corrosive following 4-h semi-occluded contact with rabbit skin. There was no indication of any irritation at time points from 1 to 72 h.

The key eye irritation/corrosion study (Notox, 1999, 262597) reported that at 1h the neat test material caused mild conjunctival redness which had resolved by 24 h. There were no other observations at any time point from 1 to 72 h.  

Minimal to mild findings indicative of irritancy in the nasal tissues were noted in the repeated dose 90-day inhaled study (DCC, 2013).

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:
adverse effect observed (irritating)

Additional information

The key skin and eye irritation studies were the only studies available for these endpoints. Both were well conducted, well reported, relatively recent studies that were compliant with GLP, so were therefore assigned Reliability 1.

In the 90-day repeat dose inhaled toxicity study (DCC, 2013) findings in the nasal tissue included increased incidence and severity of inflammation and hyperplasia consistent with a mucosal irritant.


Justification for classification or non-classification

Based on reliable in vivo skin and eye irritation studies, D6 does not meet the criteria for classification as irritant according to Regulation (EC) No. 1272/2008.