Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

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

General principle of read-across is based on: (1) similar physicochemical properties, (2) structural analogy and (3) similar mode of action in the body (toxico-kinetics; biotransformation).

In the case of PG and HPGds, these are all fulfilled:

-         Physicochemical parameters were determined;

-         Structural similarity is obvious;

-         Mode of action/bioavailability/~transformation is the same (action) and not assumed to behave differently.

 

See the attached documentation for read-across specific motivation for registration of PGds.

 

Read-across proposed have been checked using the OECD Toolbox v. 1.1.01 and the outcome is the same for both substances.

Dane salts are hydrolysing substances designed to protect a functional group during chemical synthesis, and to easily release the parent molecule. So they can be expected to behave as the parent molecule, as hydrolysis will occur in living organisms or in environment.

Read across from D(-)-p-hydroxyphenylglycine Dane salt (K, methyl, CAS n° 69416-61-1) to D(-)-alpha-phenylglycine Dane salt (K, ethyl, CAS n° 961-69-3) is supported, beyond the structural similarity, by the following mechanistic criteria, similarities, as evaluated by the OECD Toolbox:

-        Protein binding: potentially can cause skin sensitization as a result of protein conjugation via Michael-type nucleophilic addition

-        No DNA binding potential

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