<b>Bijsluiter</b>. De hyperlink naar het originele document werkt niet meer. Daarom laat Woogle de tekst zien die in dat document stond. Deze tekst kan vreemde foutieve woorden of zinnen bevatten en de opmaak kan verdwenen of veranderd zijn. Dit komt door het zwartlakken van vertrouwelijke informatie of doordat de tekst niet digitaal beschikbaar was en dus ingescand en vervolgens via OCR weer ingelezen is. Voor het originele document, neem contact op met de Woo-contactpersoon van het bestuursorgaan.<br><br>====================================================================== Pagina 1 ======================================================================

<pre>E-mail
Verzonden: vrijdag 22 januari 2016 16:35
Aan: GR_draftOSH@gr.nl
Onderwerp: chromium (VI) compounds
Hoi Stefan
Hierbij een reactie op het Chroom (VI) rapport . Slechts een paar kleine maar mogelijk wel belangrijke
opmerkingen:
  -    Pagina 4 en 5, en pagina 74. Hier wordt gemeld dat de classificatie voor fertiliteit zou moeten zijn: Cat. 1B,
       H361f. Dit moet dan echter wel zijn H360f (wel correct op pagina 73).
  -    Pagina 10 en 11. Doordat op pagina 11 de relatieve dichtheid van ammonium chromaat wordt aangegeven
       met 1,9 g/cm3 (dus met een komma), lijkt het alsof alle getallen genoemd op pagina 10 (bij
       wateroplosbaarheid) ook gelezen moeten worden met een komma, dus 1,667 g/L in plaats van 1667 g/L.
       Om verwarring te voorkomen zou de komma beter weggelaten kunnen worden.
Hartelijke groet,
Josje Arts
AkzoNobel NV
</pre>

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<pre>DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention

LC National Institute for Occupational
rere |

Safety and Health
1090 Tusculum Avenue
Cincinnati OH 45226-1998

February 25, 2016.

The Health Council of the Netherlands

Attn: Mr. S.R. Vink/Cie543

PO Box 16052 |

NL-2500 BB The Hague

the Netherlands

Dear Mr. Vink:

Thank you for the opportunity to review the draft report on Chromium (VI) compounds
prepared by the Subcommittee on the Classification of Reproduction Toxic Substances, a
Committee of the Health Council of the Netherlands. Comments are enclosed that were
prepared by Lee Greenawald, Physical Science Student Trainee, NIOSH/National

Personal Protective Technology Laboratory and Stephen S. Leonard, Research Biologist,

NIOSH/Health Effects Laboratory Division, 1095 Willowdale Road, Morgantown, WV

© 26505-2888.

If you have any questions regarding the comments, please contact me at 513-533-8260

(telephone) or by Email at tbhl7@cdc.gov.

‘Sincerely yours,

*h.D., M.P.H.

Document Development Branch
- Education and Information Division

1 Enclosure
</pre>

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<pre>Comments on DECOS draft document on Chromium (VI) Compounds
By: Lee Greenawald, Physical Science Student Trainee, NIOSH/National Personal
Protective Technology Laboratory, and Stephen S. Leonard, PhD, Research Biologist,
NIOSH/Health Effects Laboratory Division, 1095 Willowdale Road,

Morgantown WV 26505 ‘

SECTION & PARAGRAPH

COMMENT

General Comments

«The Committee’s recommendations and conclusions are
appropriate.

“The document is complete, well-supported and has clear
conclusions.

*The references valuable to this health risk assessment document
were included in the document, or presented below.

‘Consider including more summarizing paragraphs early in the
section to condense information. This depends on your intended
audience.

*Many sections did not include references where data/specific
information was discussed. Need references in these places.
*Recommend including a table of abbreviations in the beginning
of the document.

«Within the draft document NTP is listed as the National Toxicity
Program, it should read National Toxicology Program.

Sp

ecific Comments

Pg

. 2, general table of contents

Recommend including a third subclass in the table of contents
(e.g., 5.1.1 for non-human vs. human information) or re-label the
second subclass sections to denote animal or human studies (e.g.,
5.1 — Effects on fertility in non-human studies).

| Pg. 8, line 5 in chart

Suggestion: include oxidation states for clarity.

Pe.

8, line 9 in chart

Include units for molecular weight (i.e. g/mol).

Pg.

9, line 5, column 6

Correct subscripts for Chromic acid (to H:CrO°) to maintain
consistency.

. 9 line 5, columns 2 and 5

Correct capitalization on ammonium chromate (to
Ammonium) and potassium chromate (to Potassium) to maintain
consistency,

| Pg. 10, line 4, columns 2-6 Include units for relative density (like on page 11).
| Pg. 11, line 4, column 2; /2-6 Correct 1,9 to 1.9 ; apply superscript to g/cm? (to g/cm’).
| Pg. 13, line 22 Change “corrotion” to “corrosion”, as done in line 18.
Pg. 14, line 6 Rephrase “The absorption data have been considered relevant for
humans, also the oral absorption data.”
Should “dermal” be in front of the first absorption?
Pg. 14, lines 10-11 Why do most toxicity data for chromium VI compounds involve

the compounds listed? Can you provide an explanation with a
reference or is this just an observed opinion?

Pg. 14, lines 16-18 What concentrations of inhalation exposure and oral exposure
were performed to cause these effects?
| Pg. 14, line 21 What type of reactive intermediates?
Pg. 14, line 35 In what quantities?

| Pe

8. 15-24

General comment: Include references for all data listed.

</pre>

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<pre>| Peg. 16, line 6

Remove comma between “exhausted” and “has” or rephrase this
sentence.

| Pg. 17, line 32

Stay consistent with indenting new paragraphs

Pg. 18, line 3

“6 for hours/day” should be “for 6 hours/day”

Pg. 19, lines 34-35

This sentence reads strangely and seems redundant. It seems:
obvious that the absorption fraction of soluble compounds would
be higher than insoluble. Could you provide more quantitative data
for chromium (III) and compare it to the data you discuss for
chromium (VI) (pg. 20 lines 1-19) as a comparison for the
insoluble compounds?

Pg. 20, lines 34-41 + Pg. 21,
lines 26-40

These paragraphs should include more data/information because
the inhalation of chromium compounds should be highlighted
more in this document. Include references. These can be national
and international references from sources such as IARC, U.S.EPA
Integrated Risk Information System (IRIS), NIOSH, NTP, and the
California Environmental Protection Agency:
http://www.oehha.ca. gov/prop65/prop65_ list/files/P65single08010
8.pdf.

Pg. 21, row 3 in chart

Watch significant figures. Standard deviation has one more digit
than the number. Should be 55.5x or 55.5 +/- 3.0

| Pg. 21, lines 29-35

Rephrase this paragraph. Reads awkwardly and a run-on sentence.

Pgs. 25-43

*Consider having a summarizing beginning paragraph or
summarizing ending paragraph. If a summarizing paragraph is in
the beginning, it can state something like “the following data
tables support this conclusion...” etc. It is difficult to draw
conclusions in this section. n

*Also consider summarizing the nonhuman information separately
(in paragraphs) for males and females.

*If possible, make the tables i in “landscape” form for easier
visualization. ,

*Stay consistent with “et al” vs. “et al.” vs. “et al,”. It may be “et
al.,” depending on what style you are using.

Pg. 25

Be sure to identify each abbreviation (mg, kg, bw/d, h, n, etc.).
This may be obvious and depends on your intended audience. A
table of abbreviations could be included in the front of this
document.

| Pg. 38, line 20 Row 2 (in chart)

Include units for “Control”

Pg. 43, line 37.

The same time period noted (i.e. 1977-1980) was when another
study was performed (Aschengrau et al.) from drinking water in
Boston, MA on the effects of late adverse pregnancy outcomes.
This can be included in this section or Developmental Human
Studies section (page 52, line 29). Reference below:

* Aschengrau, A., S. Zierler and A. Cohen (1993). Quality of
community drinking water and the occurrence of late adverse
pregnancy out comes. Arch Environ Health 48(2): 105-13.

Pe. 67, line 17

Remove redundant reference (#27)

Pg. 68, chart & Pg. 69 chart

I like these summarizing tables. Stay consistent with et al. as noted
in previous comment.

</pre>

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<pre>Toxicokinetics section and/or
Metabolism section

There needs to be something in the “Toxicokinetics” section (page
14) or “Metabolism” (page 18) about Chromium (VI) cycling.
Chromium (VI) can be cycled (oxidized/reduced) through several
oxidation states and therefore presents some unique problems with
radical generation. I found nothing in the sections mentioned
above on Cr cycling. Please consider adding materials on this
subject, some suggested references to consider:

*Role of molecular oxygen in the generation of hydroxyl and
superoxide anion radicals during enzymatic Cr(VI) reduction and
its implication to Cr(V1)-induced carcinogenesis. Leonard S,
Wang S, Zang L, Castranova V, Vallyathan V, Shi X. J Environ
Path, Tox, Onco. 2000; 19(1&2): 49-60.

*Reduction of chromium (VI) and its relationship to
carcinogenesis. Shi X, Chiu A, Halliwell B, Castranova V,
Vallyathan V. J Toxicol Environ Health. 1999; 2:101-118.

*The role of superoxide radical in chromium (VI) generated
hydroxyl radical: the Haber-Weiss cycle. Shi X, Dalal NS. Arch
Biochem Biophys. 1992; 292:323-327.

*J Review of chromium (VI) apoptosis, cell-cycle-arrest, and
carcinogenesis. Environ Sci Health C Environ Carcinog
Ecotoxicol Rev. 2010 Jul;28(3):188-230. Chiu Al, Shi XL, Lee
WK, Hill R, Wakeman TP, Katz A, Xu B, Dalal NS, Robertson
JD, Chen C, Chiu N, Donehower L.

Final general comment, on all
charts throughout document

I am not sure if I missed a clear explanation in the text, but | am
assuming all data in all tables throughout the document are for
chromium (VI), correct? This is the objective of the document, but
perhaps a statement to clarify can be included.

</pre>

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