Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient data available: testing proposed
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
insufficient data available: testing proposed
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Since there is no sufficient data available to derive a reliable dose descriptor for any exposure route, a subchronic study for oral toxicity according to OECD guideline 408 is proposed; the available chronic study, although sufficient as a supporting study, has too many deficiencies to serve as a key study according to today's standards. However, considering animal welfare, the extraordinarily high doses applied and the lack of any treatment-related effects, it would be possible to use the determined NOAEL with reservation for the derivation of a dose descriptor. The derived dose descriptor would be converted into a correct starting point by route-to-route extrapolation based on the ECHA Guidance document "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008.

Since short-term exposure scenarios will not be assessed, only long-term DNELs for workers and the general population will be derived. The oral route is not relevant for workers. In addition it is assumed that only workers will come into contact with the neat substance. Due to the lack of an irritating or sensitising potential of the undiluted test substance the consideration of local DNELs is obsolete.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Since there is no sufficient data available to derive a reliable dose descriptor for any exposure route, a subchronic study for oral toxicity according to OECD guideline 408 is proposed; the available chronic study, although sufficient as a supporting study, has too many deficiencies to serve as a key study according to today's standards. However, considering animal welfare, the extraordinarily high doses applied and the lack of any treatment-related effects, it would be possible to use the determined NOAEL with reservation for the derivation of a dose descriptor. The derived dose descriptor would be converted into a correct starting point by route-to-route extrapolation based on the ECHA Guidance document "Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health", May 2008.

Since short-term exposure scenarios will not be assessed, only long-term DNELs for workers and the general population will be derived. The oral route is not relevant for workers. In addition it is assumed that only workers will come into contact with the neat substance. Due to the lack of an irritating or sensitising potential of the undiluted test substance the consideration of local DNELs is obsolete.