Ref.: ECHA-09-FS-05-EN
Date: 15/09/2009
Language: English

INFORMATION REQUIREMENTS FOR REPEATED DOSE TOXICITY
AND REPRODUCTIVE TOXICITY – SUBSTANCES OVER 100 (AND1000) TONNES
This fact sheet explains the information
requirements on repeated dose toxicity
and on reproductive toxicity for
substances manufactured or imported atquantities greater than or equal to 100(and 1000) tonnes per year. It highlights
which options the registrant has if ashort term repeated dose toxicity study
and/orthescreening
testfor
reproductive and developmental toxicity
test is not available at the time of theregistration. The information provided
here should help companies to decide
which data they need to include in their
dossiers for them to pass the TechnicalCompleteness Check at ECHA.
ECHA emphasises that the information
requirements indicated below constitutethe minimum for a technical dossier topass the Technical CompletenessCheck regarding the two endpoints.

Additional information may be necessary
to comply with the REACH legislationand to ensure safe use of the substance.
Registrants who decide to postpone
obtaining relevant information for
repeated
dosetoxicity
orfor
reproductive toxicity are reminded that
this has impact on their Chemical Safety
Report and Exposure Scenario/s.
developed. There, they shall include theinterim risk management measures thatthey put in place and those they
recommend to downstream users tomanage the risks in relation to the two
endpoints being explored.
The responsibility for the safe use of thesubstanceremainswiththemanufacturers,importers
anddownstream users.

REACH Fact Sheet
Repeated Dose Toxicity and Reproductive Toxicity Data – Substances over 100 (and 1000) tonnes

REPEATED DOSE TOXICITY
Information requirements for substancesmanufactured or imported at quantities! 100 t/y:
ECHA considers registration dossiers for
substances ! 100 t/y and 1000 t/y as
technically complete even if they do
not contain the results of a 28-day
repeated dose toxicity study if one of
the following conditions is met:
! The specific rules for adaptation
set out in the second bullet
under Section 8.6.1 of column 2,
Annex VIII of the REACH
Regulation apply, i.e. thesubstance undergoes immediate
disintegration and there aresufficient data on the cleavage
products.
! Annex XI.1 or XI.2 applies.
! The dossier contains the results ofa 90-day repeated dose toxicity
study.
! The dossier contains the results ofa chronic repeated dose toxicity
study (! 12 months).
! The dossier contains a testing
proposal for a 90-day repeateddosetoxicity
study
inaccordance with Section 8.6.2 ofcolumn 1, Annex IX.
! The conditions of Annex XI.3 are
fulfilled and the dossier contains
a testing proposal for a 28-day
repeated dose toxicity study inaccordance with Section 8.6.1 ofcolumn 1, Annex IX.
! In the case of testing proposals,Annex I, 0.5 last paragraphapplies.

! The specific rules for adaptation
set out in Section 8.7 of column
2, Annex IX, or Annex XI apply.
! The dossier contains either theresults of, or a testing proposal
for, a pre-natal developmental
toxicity study.
! In the case of testing proposals,Annex I, 0.5 last paragraphapplies.
! It should be noted that this does
not affect the possible need topropose a 2-generation study
already at this stage “if the 28day or 90-day study indicates
adverse effects on reproductive
organs or tissues” (Annex IX,
Section 8.7.3).
Information requirements for substances
manufactured or imported at quantities! 1000 t/y:
ECHA considers registration dossiers forsubstances ! 1000 t/y as technicallycomplete even if they do not containthe results of a screening study forreproductive/-developmental toxicity
if one of the following conditions is met:!

!

!

REPRODUCTIVE TOXICITY
Information requirements for substances
manufactured or imported at quantities! 100 t/y:
ECHA considers registration dossiers for
substances ! 100 t/y as technicallycomplete even if they do not containthe results of a screening study forreproductive/developmental toxicity if
one of the following conditions is met:

The specific rules for adaptation
set out in Section 8.7 of column
2, Annex IX, or Annex XI apply.
The dossier contains either theresults of, or a testing proposal
for, a prenatal developmental
toxicity study and either theresults of, or a testing proposal
for, a 2-generation reproductive
toxicity study.
In the case of testing proposals,
Annex I, 0.5 last paragraphapplies.

MORE INFORMATION
Questionsconcerning
information
requirementsandthetechnicalcompleteness of the dossiers can besubmitted to ECHA via the helpdesk
web form which is available at
http://echa.europa.eu/about/contact_en.asp" European Chemicals Agency, 2009

European Chemicals Agency, Annankatu 18, P.O. Box 400, FI-00121 Helsinki
http://echa.europa.eu, info@echa.europa.eu