Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
other: Summary report of investigation into handling of ADCA throughout EU supply chain
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Summary does not address a specific data requirement. Specific sources of Dust in Air monitoring data cannot be disclosed for confidentiality reasons.

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
ADCA Supply Chain and Risk Management, Keeping Workers Along the Supply Chain Protected
Author:
West Senior Limited
Year:
2015
Reference Type:
secondary source
Title:
Azodicarbonamide (ADCA) Guide for On Site Safe Use
Author:
West Senior Limited
Year:
2015

Materials and methods

Type of study / information:
Summary document assessing forms of ADCA and ADCA-containing preparations available at different stages of the supply chain within the European market. The document also considers typical risk management measures employed by users of ADCA and its preparations in order to minimise the potential for exposure to the unreacted material. Finally the document presents the results of a series of Dust in Air (DIA) measurements taken at numerous sites throughout Europe and compares the measured levels against the Workplace Exposure Limit (WEL) implemented by the UK Health and Safety Executive (HSE).
Endpoint addressed:
respiratory sensitisation
Test guideline
Qualifier:
according to
Guideline:
other: Dust in Air measurements performed according to UK HSE document MDHS92/2

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Levels of airborne ADCA (dust or particulates) were measured

TYPE OF EXPOSURE MEASUREMENT: Area air sampling and personal sampling

EXPOSURE PERIOD: 8-hour Time Weighted Average (TWA) and 15-minute Short Term Exposure Limits (STEL)

DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES:
Measurements were categorised by the role in the supply chain, and the form of the substance at the time of measurement:
Roles: Distributors, Compounders, Formulators, and Downstream users (i.e. manufacturers of articles).
Form: Powder, dispersion, masterbatch (solid system), post manufacture (trimming or cutting of articles after decomposition of ADCA).

Results and discussion

Any other information on results incl. tables

Distrubutor (1 site)

- sampling of the warehouse during storage and stock movement recorded non-detectable levels of airborne ADCA. All packaging remained sealed and ADCA was merely relocated for onward shipments.

Compounder (3 sites)

- all using ADCA powder. Both personal and static tests were performed and all samples taken fell below the UK occupational exposure limit of 1mg/m3 (8 hour TWA)

Formulator (3 sites)

- main usage powder form with one site preparing masterbatch. Personal and static tests were performed.

Results (2 sites) 8 hour TWA

Granular masterbatch - results below 0.03mg/m3

Pre-weighed sachets - results below 0.06mg/m3

Results (1 site) 8 hour TWA

While there was zero exposure when using masterbatch, values in excess of the 1.0 mg/m3 were seen for the 8 hour TWA. It should be noted that an in-house monitoring procedure was used so results are not directly comparable. High levels of worker RPE are in use so actual exposure will be less than that recorded. Further monitoring work is likely to be undertaken.

Downstream user (18 sites)

- 5 sites dust free ADCA (liquid dispersion, granular masterbatch or powder in sealed pre-weighed sachets)

Results using liquid dispersion were found to have levels below the detectable limit of testing as an 8 hour TWA.

13 sites using ADCA in powder form, either pure or diluted.

Average values for the 8 hour TWA from powder use fall significantly below 1.0mg/m3. One value was found in excess of 1.0mg/m3 however this may be an error in result as other values for this site fall within expectations.

Short term exposure levels were measured in 5 sites and all values were less than the 3.0 mg/m3 UK occupational exposure level.

Five sites monitored levels of ADCA near sawing/trimming units used after foaming to evaluate the risk of airborne ADCA dust when handling or cutting articles. Results form 15 samples showed non detectable levels of ADCA confirming that ADCA fully decomposes during use and any residual levels are low and encapsulated.

Applicant's summary and conclusion

Conclusions:
Low dust forms have been shown to significantly reduce industrial exposure to free ADCA dust. ADCA was not detected during cutting operatations involving articles showing that there is no risk to consumers.