Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
DNEL (Derived No Effect Level)
Value:
1.23 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

No mammalian toxicity information is available on the reaction mass itself, as its constituents phenol and BPA are well characterised and any testing of the reaction mass prohibits itself because of the toxicity of phenol.

While the reaction mass consists of up to 25% (sum) impurities, no toxicological data are available to evaluate the hazard profile of the impurities. Due to the relatively high hazard posed by phenol, which drives strict exposure control measures, and the lower concentration of the impurities, it is highly unlikely that the impurities would have a relevant impact on the human health hazard profile or the work place risk management measures.

Please note that due to the extensive datasets available for BPA and phenol, the constituents of the reaction mass, we refrained from including all available data on both substances into this dataset, but used the key and weight of evidence information of phenol and BPA to document the hazard profile of the reaction mass.

Additivity of the effects of phenol and BPA is unlikely as both components have different toxicological profiles. Nethertheless, the effect levels derived for the components will not be adapted to the lower concentration in the reaction mass, but employed directly for hazard characterisation for the sake of simplicity.

The DNEL derivation for the reaction mass is

based on the IOEL for phenol set by the SCOEL in 2003, as no new data which would change the assessment by the SCOEL became available since then. The STEL of phenol was not adopted for the reaction mass, as the STEL of phenol (16 mg/m3) would exceed the OEL for BPA (10 mg/m3) for which no STEL was defined, as the OEL is based on respiratory irritation effects. Therefore, no separate inhalation short term DNEL was defined for the reaction mass, but the long-term DNEL will cover the endpoint.

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