Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000 to april 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2016

Materials and methods

Type of study / information:
634 monitoring data from German industries from 2000 to April 2016 have been generated for Benzyl alkohol.

The number of data (634) 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 guidanc e 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.
Endpoint addressed:
acute toxicity: inhalation
repeated dose toxicity: inhalation
Test guideline
Qualifier:
according to
Guideline:
other: Standardverfahren im MGU (Stand 2003)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further information

Method

Ethical approval:
not applicable
Details on study design:
total number of data 634
Sampling wiht sampling device at the worker: 210
Sampling with fixed sampling device (persons related to exposure assessment): 121
Sampling with fixed sampling device: 214
Sampling with fixed sampling device (basic load related to exposure assessment): 89

number of data < determination limit: 563
exposue period >= 6h: 538
exposue period < 6h: 95

- with a sampling pump with Tube Holder a defined air volume is drawn through activated carbon tubes type b
- extraction with methanol / dichloromethane / carbon disulfide (2 : 1 : 1)
- gas chromatography determination with FID
- limit of detection:2 mg/m3

Examples for monitoring data of industry branches:
- Building industry 33 values
- chemical industry 20 values
- Printing industry with paper and paperboard production: 41 values
- Electrical engineering and fine machanics: 47 values
- Glas industry: 12 values
- Ceramic industry: 17 values
- Polymeric industry: 59 values
- Metal working industry: 91 values
- Surface coating: 52 values
- Mining: 10 values
-other branches: 43 values

Results and discussion

Results:
statistical evaluation for workgroups area
- no restriction
Exposure Period: >= 6h, 361 values, 215 companies, 90 % value: 4.97 mg/m3
Exposure Period: < 6h, 89 values, 89 companies, 90 % value: 4.035 mg/m3
- Handling, finnishing, processing procedure: Exposure Period: >= 6h, 10 values, 7 companies, 90 % value: 1 mg/m3 (The distribution value is below the highest limit (BG) in the collected data. The BG may differ z. B. a function of the sampling or the volume flow of the mentioned in the introduction limit.)
- Printing operation, pouring, glueing, laminating, installation (general): The number of readings below the limit of quantification (BG) is greater than the number of measured values, which are represented by these cumulative frequency value. Therefore, no concentration is specified for this cumulative frequency value.
- filling, mixing, packing, supporting, weighing: Exposure Period: >= 6h, 21 values, 14 companies, 90 % value: 1.9 mg/m3 (The distribution value is below the highest limit (BG) in the collected data. The BG may differ z. B. a function of the sampling or the volume flow of the mentioned in the introduction limit.)
pooring
- Surface treatment: Exposure Period: >= 6h, 25 values, 20 companies, 90 % value: 25.5 mg/m3
- Surface coating: Exposure Period: >= 6h, 134 values, 83 companies, 90 % value: 7.44 mg/m3 (The distribution value is below the highest limit (BG) in the collected data. The BG may differ z. B. a function of the sampling or the volume flow of the mentioned in the introduction limit.)
Cleaning: Exposure Period: >= 6h, 18 values, 9 companies, 90 % value: 12.4 mg/m3
- other working areas:
Exposure Period: >= 6h, 43values, 33 companies, Exposure Period: < 6h, 14 values, 10 companies, 90 % value: The number of readings below the limit of quantification (BG) is greater than the number of measured values, which are represented by these cumulative frequency value. Therefore, no concentration is specified for this cumulative frequency value

Applicant's summary and conclusion

Conclusions:
88.8 % of the data are lower than the llimit of detection (2 mg/m3)