Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

A classification as respiratory sensitazer has been proposed for lysozyme hydrochloride. Currently there are no available methods to determine thresholds and DNELs for respiratory sensitizers. Therefore, substances classified as a respiratory sensitizer according to the CLP Regulation (EC 1272/2008) should normally result in a qualitative assessment for the hazard level of concern.

Respiratory sensitizers according to CLP are allocated to the high hazard band on the basis that exposure to such substances should be strictly contained because they may cause serious health effects for which a dose threshold is not usually identifiable.

There is evidence from both human and animal studies, which indicate that effective sensitisation of the respiratory tract, can result from dermal contact with a chemical respiratory allergen. Thus, it is thought, that the effective prevention of respiratory sensitisation requires appropriate protection of both respiratory tract and skin.

The approach followed is based on the principle that the higher the hazard, the stricter the controls need to be. The conditions of use (operational conditions (OCs) and risk management measures) as set out in the exposure scenario will reflect the severity of the hazard.

Substances categorised as having a high hazard profile (i.e. respiratory sensitizers), a very high level of containment, automatic dosing/feeding to the process, and appropriate PPE are recommended in occupational settings in order to avoid exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (respiratory tract)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

A classification as respiratory sensitazer has been proposed for lysozyme hydrochloride. Currently there are no available methods to determine thresholds and DNELs for respiratory sensitizers. Therefore, substances classified as a respiratory sensitizer according to the CLP Regulation (EC 1272/2008) should normally result in a qualitative assessment for the hazard level of concern.

There is evidence from both human and animal studies, which indicate that effective sensitisation of the respiratory tract, can result from dermal contact with a chemical respiratory allergen. Thus, it is thought, that the effective prevention of respiratory sensitisation requires appropriate protection of both respiratory tract and skin.

Respiratory sensitizers are allocated to the high hazard band on the basis that exposure to such substances should be strictly contained because they may cause serious health effects for which a dose threshold is not usually identifiable. In order to a precautionary approach, an high level of hazard has been considered also in the case of general population for the Chemical Safety Assessment; nevertheless, it has to be taken into account that lysozyme hydrochloride under registration is mainly used for industrial purposes and that consumers uses are not envisaged.