Carbonic acid, diphenyl ester, reaction products with bisphenol A

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

8 mg/m³

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

8 mg/m³

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

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

Acute/short term exposure

Hazard assessment conclusion:

no DNEL required: short term exposure controlled by conditions for long-term

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - workers

Strictly Controlled Conditions as set out in Article 18(4) (a) to (f) of REACH do apply on the workplace throughout the life cycle of SPC resin (for details see section 13 of IUCLID data set). Respiratory, hand, eye and skin protection and hygiene measures are required. Exposure of workers may therefore be considered as negligible (further information is given in sections 9.x.1 of the respective exposure scenarios in the CSR). However, to complete the picture voluntarily for SPC resin DNELs for workers have been derived following the worst-case read-across approach.

SPC resin is a complex substance (UVCB) which can be regarded as a mixture of the monomers phenol, diphenyl carbonate (DPC), and 4,4’-isopropylidenediphenol (BPA) and their condensation products in which the monomers play the decisive role for human health. All three monomers are systemically available in laboratory animals after oral, dermal or inhalative exposure. They are toxicologically well investigated, show a comprehensive toxicological data base and have all been assessed in authority based peer review processes. Therefore, in line with Annex XI of Regulation (EC) No 1907/2006, read-across was chosen for the registration of SPC resin and no animal study has been performed with SPC resin itself. However, to substantiate the read-across hypothesis toxicologicalin vitrostudies with SPC resin have been performed; based on the results of these in vitro studies the read-across approach is supported (for details see attached document ‘Justification for Read-Across and Human Health Classification’ in section 13 of IUCLID data set).

The three monomeric components in SPC resin (phenol, DPC and BPA) are registered in the > 1000 t/y tonnage band in the EU and DNELs are available on ECHA´s website. Of the three monomers phenol is chosen as most relevant for DNEL derivation of SPC resin for the following reasons:

•    Phenol shows the highest vapour pressure (20 Pa, 20°C) of the three monomers. Thus, if any exposure of workers with SPC resin via inhalation occurs, phenol is the most volatile and therefore, with regard to potential exposure, the most relevant component of SPC resin for the inhalative route. Since DPC (0.014 Pa) and BPA (1.6 x 10^-7Pa) both show much lower vapour pressures than phenol, exposure to their vapours can be expected to be negligible in comparison to that of phenol.

•    Phenol can be considered as the component with highest acute toxicity (Acute Tox 3) and strongest local effects (Skin Corrosion 1B) in SPC resin. A dermal absorption rate of 80% is assumed for risk assessment of phenol (section 7.1.1 of IUCLID data set). Therefore, with regard to a potential accidental dermal exposure of workers during handling of SPC resin, phenol will be the most toxic component.

•    The amount of phenol can add up to 90% in SPC resin and is therefore the component with the highest possible concentration in SPC resin

For phenol an official European Occupational Exposure Limit (OEL) of 8 mg/m³ (8 hour value; equal to 2 ppm) and Short Term Exposure Limit (STEL) of 16 mg/m³ (15 min value; equal to 4 ppm) was published in 2009 (Directive 2009/161/EU of 2009-12-17). These values are taken as surrogate DNEL for long term inhalation exposure to SPC resin in accordance with DNEL derivation for phenol.

For acute dermal systemic and local effects as well as for long-term dermal local effects DNELs are not derived since phenol is classified as corrosive and corrosivity requires specific risk management measures which lead to no exposure.

A DNEL for acute inhalation toxicity is not considered since the long-term DNEL is sufficient to ensure that these effects do not occur.

 

Worker-DNEL long-term for inhalation route - systemic and local

DNEL worker long-term inhalation systemic and local =

official OEL for phenol of 8 mg/m³ (2ppm) for an exposure time of 8 hours
(Directive 2009/161/EU of 2009-12-17; SCOEL/SUM/16, 2003)

 

Worker-DNEL acute for inhalation route - local

Besides the official OEL for phenol of 8 mg/m³ (8 hour exposure) there is an official short-term exposure limit (STEL) value for phenol of 16 mg/m³ (maximal exposure time of 15 min) available (Directive 2009/161/EU of 2009-12-17; SCOEL/SUM/16, 2003) which could be used as acute DNEL for inhalation of SPC resin, local effects. However, using the Chesar 1.2 tool for risk characterization in combination with IUCLID 5.3 no numerical values for acute local DNELs are accepted. In order to process this substance in IUCLID 5.3/Chesar 1.2 and since inhalation exposure of workers to SPC resin is strictly controlled and will not exceed the OEL of 8 mg/m³ this value will be used for risk characterization and not the higher STEL of 16 mg/m³. Therefore a DNEL for acute inhalation toxicity is not considered since exposure is significantly below the long-term DNEL for all exposure scenarios.

 

Worker-DNEL long-term for dermal route-systemic

Long-term dermal DNEL for systemic effects is derived by route to route extrapolation from the long-term inhalation DNEL.

Relevant dose-descriptor for the endpoint concerned: official OEL for phenol of 8 mg/m³

(Directive 2009/161/EU of 2009-12-17; SCOEL/SUM/16, 2003)

Correction of starting point: Route of exposure (inhalation versus dermal exposure): OEL of 8 mg/m³is converted to 80 mg/person/day assuming a breathing volume of 10 m³in workers (occupational exposure during 8 h shift). An average person weight of 65 kg is taken for assessment of phenol, in accordance with the DNEL derivation for phenol.

8 mg/m³x 10 m³/d /65 kg= 1.23 mg/kg bw/d

Assessment factors relating to the extrapolation procedure: Assessment factors have already been included in derivation of OEL, therefore no further assessment factor required.

Overall assessment factor: 1

DNEL worker long-term dermal systemic =1.23 mg/kg bw/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

exposure based waiving

Acute/short term exposure

Hazard assessment conclusion:

exposure based waiving

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

medium hazard (no threshold derived)

Additional information - General Population

The substance is not used in the public domain and direct exposure of consumers is thus not to be expected. Exposure of man via the environment is negligible and indirect exposure of consumers is thus not to be expected. Therefore no DNELs for the general population were derived.