ISO commenting template/Report of voting
1MBClause /subclause(e. g. 3.1)

Paragraph/
Figure/Table(e. g.
Table 1)

Typeofcom2
ment(e. g.
ed)

Date : 2001-10-17
Comments: Justification for change

Document: DIS 10993-12

Proposed change

JISC

10.3.1 e)ed(21±2)℃ for (1±0.1)hourfor (1±0.1)hourJISC

10.3.4 d)teThe present ISO 10993-10 (Irritation andSensitization) contains the clause, which is shownin “ “ in the right column, in its Annex B.2.10 c) andNOTE 15, but will be removed from the revising Part10 because of the TC policy of simplification byreferring the Part 12.

Add the following NOTE under 10.3.4 d):"For sensitization testing, various organicsolvents, e.g. propanone (acetone),methanol, chloroform, diluted surfactant, andmineral oil may be used."

JISC

10.3.9te

The present Part 12, Annex C.4 c) describes "Sometest methods require concentration of extracts toincrease the sensitivity of the test." Contrarily in thecurrent DIS, it is changed as "An alternative practiceis repeated extraction followed by concentration to
obtain sufficient extractable substance(s). This
practice is only applicable for the purposes ofhazard identification and risk estimation in
exaggerated-use conditions." These are notcompletely same. Also, it must be considered thatthe present ISO 10993-10 includes the following
clause, which must be included appropriately in therevised Part 12:" Annex B.4.5 - An alternative
sample extraction procedure using volatile solvent,followed by evaporation of the solvent andapplication of the residue to the animals, may beundertaken for polymeric materials for sensitization
testing." We propse to add the NOTE for clarifying
what are "the specific test methods" and "thespecific cases" where exaggerated extraction
practice is recommended, and for including therationale of Annex B.4.5 of the Part 10.

Add the following NOTE under 10.3.9: "Dueto the limited nature, sensitivity of andapplicable sample volume to, the test
system, exaggerated extraction may berecommended for sensitization and in vitro
genotoxicity tests of polymeric materials (seealso C.4)."

JISCAnnex Aed

E-mail address has been changed

Old: tanac.noriho@nifty.ne.jp12Foot Note3),4),5),13), 14) &15)

Observations of the secretariat
on each comment submitted

should read (121±2)℃

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorial

New: RM.Office@fdsc.or.jp

NB Columns 1, 2, 4, 5 are compulsory
page 1

FORM 13B (ISO) 2001-07-01

ISO commenting template/Report of voting
1

MB

Clause /subclause(e. g. 3.1)

JISC

Annex AJISCAnnex AJISCAnnex C

12Paragraph/Figure/Table(e. g.
Table 1)

Typeofcom2ment(e. g.
ed)Foot Note4)

edFoot Note5)

ed

C.4

teDate : 2001-10-17
Comments: Justification for change

type error

Document: DIS 10993-12

Proposed change

Observations of the secretariat
on each comment submitted

From 4) HDPE film: RM-C
To HDPE sheet: RM-D

type error

From 5) HDPE sheet: RM-C
To HDPE rod: RM-E

This practice is an example of exaggerated
extraction. For harmonizing with the clause 10.3.9
and the proposed NOTE for it given by us, thewords “and risk estimation” are deleted. Moreover,
we think that this practice may sometimes beapplicable for risk evaluation. We therefore
proposed to delete “only” before “applicable.”

MB = Member body (Enter two-letter country code, e. g. CN for China)
Type of comment: ge = generalte = technicaled = editorial

The second sentence should read “Thispractice is applicable for the purpose ofhazard identification.”

NB Columns 1, 2, 4, 5 are compulsory
page 2

FORM 13B (ISO) 2001-07-01