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Department of Treeentire Nedielne and Industrial Health
The lettering Laboretory CoUega of Uedlcine > (dan In, Cincinnati 19, Ctelo
Jamary t$, 1952 ?
Hr, Kanfred Bowdltch Lead Industries Is societies) lt20 Lexington lvrat law lork 17, Rew fork
Dear Kr. Bowdilchi
I em enclosing the final report on the six lead c napoorate which were evaluated by repetitive human patch tests. If there are any <}ue) tlow about the details of the report,' please do not hesitate to contaminate with me shoot then.
Too understand, X am sore, why It is unwise to predict vsafe reactions from our results insofar as flliae containing these co^ounde ere concerned, k vinyl plastic oontaliring aiqr of the eteblllaere would probably provide auch leee cutaneous contact with the stabiliser Itself then the petch device need in the experiment. In our Initial discussions you will recall, hovsvtr, that It was decided to evaluata tha compounds out of thalr resin wllleu before going ea to tests which mould eeploy films Incorporating the stabilisers, is it turns out, the latter evaluation becone* quite neceesary la order to understand what cutaneous reactions are possible from retire containing the lead cosgwunds,
'Tlth kindest personal regards, X am
Very sincerely yours, ' <? // Raymond R. Sueklad % : * Raymond R. Suaklnd, V.D. &h Staff Dermatologist
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1, Purpose Tha object of the experimental procedure Wl to detarnine
the irritant and Mnsltlslnf proportion for banan akin of six lead compounds eubnltted ty tha Lead Industries Association.
t. Conclualona Under the conditions of tha evaluation procedure aai,
five of tha eonpounda wars observed to evoke a nail natxr of primuj Irritation raactiooa. Tbay vara dibasic load stearate, trlbaslc uluta, rornal load salicylate, baalo allietta i<e load and baalo carbonate vhlta load. Jhe lead orthos111*,eta and silica pol eras obaarrad to aoka Moderate natar of {arlauy Irritation reactions, but tha raaulta vara not entirely consistent, In that t*o successive aarlaa of taata of this preparation on tha aaaa subjects, aftar an intonral of 2 Wales, yielded dlffarant tasters of reactions. Sensitisation did not appear to be a factor in tha cutaneous reactions nteloh ware Induced.
3. Materials Materlalai Each of ala lead eonpounda was incorporated
in a aathocal vehicle Meh was aada up by nlxlnc 50 frame of aathocal (1000 epe) with 750 &ro*a of wter. The eonpounda are used in the follo*lnf concentrations#
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CL, dibatic bad eUarata (MW bitch Bo/) /?. tribute laad e*lMt (Triaifl bitch 8c/)
1.02 1.02
/3. laad orthoalllcata and alllea gal (Plisb-O-dll '
Dutch Bov) 6,0f
A. noraal laad aalicylata (Korvasal. Dutch Boy) 0.52
f$. baalc elllcata vhita laad (*gla Plchar)
5.02
#6. baalc carbonata whita load (John B. Hoc Orator )6.02
Iba concaotratlona anpleyad In thin axparlnant rapraoanted
tha marl wai coneantratlon of aach ecvpound racowaandad for <M
In tha ccanerolal fonaulatloa of vinyl plaattca.
k. Experlaental Trocadiro
X avail aaoant of aach vlxtura was appliad with a toogM
blada upon tha aids of tha lunar aapact of tha uppar ara of
faoaan ratjacto, coverad and retalnad in place vith a Ccraterclal
patch (Band-Aid Patch) which conaiatod of a 2 Z t ca (BUM
oquara and a ventilated adhaalva covar 3.5 z 3.5 ca. Tha
application altea were obaerved L8 hoere and 96 hour* aftar
application,
procadura m repeated tao aaaka aftar
tha Initial application enployir^ tha aasa cvtanaooa araaa
of tha ldantical group of auhjaota*
5. flubjacta Tan hundred and forty-elz aubjacta vara avplo/ad la tha
initial teat of uhleb 19k vara available for rataating. Tha a\*Jacta vara all faaalaa with preeuMbly noraal akin.
6. Baaulta Tha raaulta art praaantad In tabular font on tha following
pagai
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Patch ?rt Ob.arvatloto -- piret Serial
5ubtar>c
Kunber of
Sublet*
K*XtivE.actlon*
.............. 1 1.......................................---- P&*ltiTt Resellna Tbtel Javjab#r Per Cent
Frit.ir 1 fbeitive
2* >
Reaction* Reaction!
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21*0
51
0
6 2.1*
X
2k6
2i*l
23
0
5 2.0
3
TU
221
19 6
0
25 10.2
b
2L6
236
6b
0
10
b.l
5
ZL6
23T
81
0
9 3.7
6
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32
0
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. o . patch Tret Obnarration* Second Sariel
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Ruribar Relative Positive Reaction! Tbtal Kucher Per Cent
SubaUnce of Reaction*
Positive Itoaltlv#
Subjact*
1* 2* >
Reaction! Reaction!
1
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91
0
10
5.2
t
19b
190
b0
0
b 2.1
3
X9U
166
51
0
6 3.1
b
1?**
166
51
0
6 3.1
5
19li
168
33
0
6 3.1
6
19!*
190
1* 0
0
b 2.1
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Kona of the rub Sod* In rhea reaction# war# obe erred In the first eerlos reacted In the eeoond series*
7. Mac u stop
In response to U.e first snrt.ee of appltc*tlon* the percentage of subjects exhibiting reaction* to one or another of the six coepounda ranged fro* 2.0 to 10.2, the greeteet nt*S>*r being evoked by contact with the orthoeillcste end Ulce gel. following the second series of Applications the Incidence of reectlone ranged fro* 2.1 to 5.2 per cent, the frequency with which reectlone were evoked by four of the substances, l.e., trlbaslc lead aaleate, normal lead aallcylato, bslc silicate white load and basic carbonate idiite lead did not differ significantly in the first and aaoond teata. On the other hand only 3.1 per cent of the subject* reacted to the orthoalllcate and elllct gel In the second series, 10.2 per cent reacted in the first. None of the subjects whose skin reacted after the first application, reacted following reapplication two weeks later. In the esse of the dlbaelc stearate the percentage of reactors was slightly greater In the second series. The difference in the percentage of reactions In the two series can only be explained by difference* in local physical factors In the two serlss of tests. Those factors are not easily controlled snd Include aeblent temperature, hualdlty, sweating, exercise, local friction end preeeure (by outer clothing), type of cutaneous contact, end local ventilation. Nevsrthol***, the Rusher ct reaction^ was such that it way be said that under the conditions
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of th* prevent teat the dibaale lead etearat*, tribute laid Bile*!*, ncnsal lead sallcylata, biic silicate white load and bcaie carbenete white lead cy be wildly irritating and that th* crthoE.ilteat* and alllc* gel Bay be ooderatoly
irritating. Sine* thla patch teat aralaatlon 6coa tot
duplicate tK* uiaga condition*, It >K>ald be un>ri to ocnclud* that any of th* aix load cocpounda would b* nilElly or Moderately irritating when incopcrated In th* plaatic.
6. Recoasendetlon* It 1* *ugreeted that aiwllar patch teat* b* carried out
on 200 *ub>ct* ecploytng vinyl plaatic* containing wavlw conc*ntration* of each of th* alz Iced cespounds, with aultabl* Vcyl plaatic control fllxa which do not contain th* lead co^ownd*,
Trcm th* Kettering laboratory In th* Cwpartnant cf Preventive Uodlclne and Induatrial Health and th* Daparteant cf Darwatology *nd Syphilology, College of Medicine, Unireralty of Cincinnati.
Cbaenration* byi
Raywond R. Suaklnd, M.S,
Abo * Ja*bor, V.S. Jtuth forny# ft.R.
Report byt
Raymond R. Suekind, M.D,
January ?lit lp$2
Approvedi /*/ Robert A. Xeho* ICKrl jr/JEa7,"KB:
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