Registration Dossier

Administrative data

Description of key information

Air monitoring results from 2 manufacturing plants over 15 years (1997-2011) show   that concentrations were up to 0.91 mg/m³ (8h-TWA) and 1.87 mg/m³ (15 min short-term exposure) with 90th percenentiles of 0.9 mg/m³ (short-term) and 0.07 to 0.23 mg/m³ (shift exposure).
Occupational medical surveillance with data collected in the same period (1997- 2011) in the 2 manufacturing plants did not reveal any health effects like irritations of the skin, mucosa membranes or upper respiratory tract which could be derived to be from a possible cresol exposure at workplace.
Biomonitoring showed that in case of routine handling of cresols with required protection devices but no respiratory protection devices, cresol concentrations were in all cases below the limiting value of 200 mg cresols / l urine (Leng 2012).
Monitoring results from German industries handling cresols, are available for the period 2000-2011: 98.7% of the values (short-term and long-term) are below the limit of quantitation (<0.5 mg/m³)..

Additional information

MONITORING DATA

A report from Allmendinger (2012) comprises air monitoring results from 2 productions plants manufacturing o-, m- and p-cresol. Each site produces or processes several thousand tonnes cresols per year. Exposure levels have been measured in the period from 1997 to 2011 related to all relevant activities of the workers where exposure to cresols was likely. In total, 63 air monitoring data are available, 27 for short-term exposure (<15 minutes) and 36 for shift exposure (8h-time-weighted average, TWA). Risk management measures (RMM`s) and operational conditions (OC`s) for the worker`s activities and the processes are documented and described in this report. Thus, process categories (PROC`s) could be attributed to the activities. According to the criteria described by ECHA guidance document R14 (2010), this reports meets the “High quality data band”. Data confidence is high, and the data enable a decision whether there is safe use. The number of data (63) is sufficient according to ECHA (2010). Variation and uncertainty of the data is low for both, the true variation in exposure and on the other hand by the knowledge about representativeness of the data.

Additional data from German industries are available from IFA (2012) comprising 693 monitoring data for 60 industry branches and 138 working areas. The main processes are defined by the working areas. Risk management measures (RMM`s) and operational conditions (OC`s) for the worker`s activities and the processes are documented and described in this report. However there may me a need for more information as RMM`s and OC`s are not clearly attributed to the processes in detail. The number of data (693) is sufficient and exceeds greatly the requirements of ECHA (2010) and is therefore expected to cover the whole range of RMMs and OCs applied in the relevant industry branches. According to the criteria described by ECHA guidance document R14 (2010), this reports meets the “High quality data band”. Data confidence is high, and the data enable a decision whether there is safe use. Variation and uncertainty of the data is low for both, the true variation in exposure and on the other hand by the knowledge about representativeness of the data

Assessing the air monitoring results it becomes evident that the results from both reports are consistent. The data from the manufacturing process (long-term 90th percentiles 0.07-0.23 mg/m³) are supported by very detailed descriptions of RMMs and OCs. The study for exposure in German industry with 693 mesurements, however with lack of detailed description of RMMs and OCs, yielded a result of <0.5 mg/m³. As these results are in consistency it is concluded that the standard of RMMs and OCs in German industry using cresols is similar to the conditions at the chemical`s manufacturing site. Thus, a very broad and reliable data set is available enabling a decision whether or not there is safe use.

HEALTH SURVEILLANCE

This report comprises medical investigations performed with workers from 2 productions plants manufacturing o-,m- and p-cresol. Each site handles produces or processes several thousand tonnes cresols per year. Data from about 100 workers per year over a period of 15 years (1997-2011) have been evaluated. Exposure levels have been measured by air monitoring (Allmendinger 2012) showing that concentrations were up to 0.91 mg/m³ (8h-time-weighed average) and 1.87 mg/m³ (15 min peak exposure). Biomonitoring results in urine confirmed that workers were exposed to cresols.

Every year, a medical examination of the staff is performed as a precaution in accordance with German Gefahrstoffverordnung § 16(2). This examination includes e.g. medical history, physical examination, lung function, ECG/Ergometry, vision-testing, audiometry, laboratory examinations of blood and urine as well as a biomonitoring (measuring of working substances in blood and urine).

Occupational medical surveillance did not reveal any health effects like irritations of the skin, mucosa membranes or upper respiratory tract which could be derived to be from a possible cresol exposure at workplace during routine handling when no respiratory devices were used.

Biomonitoring showed that in case of routine handling of cresols with required protection devices cresol concentrations were in all cases below the limiting value of 200 mg cresols / l urine (Leng 2012).