Registration Dossier

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: summary report The full study report is attached in section 13: Kresol, Leng full study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Study type:
health record from industry
Endpoint addressed:
acute toxicity: inhalation
repeated dose toxicity: inhalation
Principles of method if other than guideline:
Over a period of 15 years (1997-2011) both, exposure levels have been measured (Allmendiger 2012) and medical examination of the staff was performed in accordance with German Gefahrstoffverordnung §16(2).
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
2 production plants producing o-, m- and p-cresol (no further details)

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
Over a period of 15 years (1997-2011) both, exposure levels have been measured (Allmendiger 2012) and medical examination of the staff( about 100 workers) was performed in accordance with German Gefahrstoffverordnung §16(2).
These examinations included mecical history, physical examination, lung function, ECG/Ergometry,vision-testing, audiometry, laboratory examinatios of blood and urine as well as a biomonitoring(measuring of working substance in blood and urine by gas chromatography/mass spectometry[GC/MS])

Results and discussion

Results:
---Exposure data ( see Allmendinger 2012):
concentrations up to 0.91 mg/m³ (8h-time-weight -average) and 1.87 mg/m³(15 min peak-exposure)

---Physical examination
There has been no sign of cresol derived symptoms in all the years
--- Lung Function test
There have not been any pathological lung function test results in context with the working place
(sources which could influence the lung function test like smoking or contact to other irritative or allergenic substances as well as medical history were taken into account)

---Biomonitoring data
All measured values are below the limit value of 200 mg/l urine (Biologische Leitwert as published by MAK/ BAT-commision of DFG)


Applicant's summary and conclusion

Executive summary:

Over a period of 15 years (1997-2011), in German production plants, both, exposure levels have been measured (Allmendiger 2012) and medical examination of the staff (about 100 workers/year) was performed in accordance with German Gefahrstoffverordnung §16(2). Concentrations up to 0.91 mg/m³ (8h-time-weight -average) and 1.87 mg/m³(15 min peak-exposure) were determined. In case of routine handling of cresols with the required protection devices the occupational medical surveillance did not show any health effects in workers including medical physical and hematological examination as well as by lung function tests or biomonitoring.(Leng 2012)