Chemicals that carry the EU Risk Phrase R42: “May cause
sensitization by inhalation” [16] shall not pass the
Criteria.Chemicals
that are considered that are considered Category 1 – “Respiratory
Sensitizer” (either Category 1A and 1B) under GHS
criteria [74] shall not pass the Criteria.
Table 9 –
Authoritative Lists and GHS Criteria
Authoritative
Body
Does
not pass DfE Criteria
EU Risk
Phrase [16]
Risk Phrase
R42: “May cause sensitization by inhalation”
Globally
Harmonized System (GHS) [74]
Category 1 – Respiratory
Sensitizer
Data Requirements
Chemicals with new data not yet reviewed by authoritative
bodies will be evaluated under these Criteria.
Public
literature, EPA-confidential data, and lists of chemicals of potential concern
will be screened.Chemicals
designated as sensitizer-induced asthmagens (“Rs”) on the specified list below
will require supplemental review.All relevant data and
information used to designate a chemical as a sensitizer-induced asthmagen
(“Rs”) on the specified list will be considered when reviewing the chemical
against the respiratory sensitization criteria.
1.Association
of Occupational and Environmental Clinics (AOEC) Exposure Code List [75].
Acknowledging that
recognized animal models for the testing of respiratory hypersensitivity are
not available at present, data on respiratory sensitization will normally be
based on human evidence. Chemicals associated with hypersensitivity after appropriate
clinical testing may not pass the Criteria.See GHS guidance for further details.
Data
Interpretation
The
following sources should be consulted for additional information:
–EU Dangerous Substances Directive, http://ecb.jrc.ec.europa.eu/documentation/.To access the list of substances carrying Risk Phrases, click on
“CLASSIFICATION-LABELLING”, then “DIRECTIVE 67-548-EEC”, then “ANNEX I OF
DIRECTIVE 67-548-EEC”, and then either of the files listed as: “Annex I of
Directive 67548EEC”.[25];
–EU Dangerous Preparations Directive Article 6 and
Annex II (1999/45/EC and subsequent updates/amendments) [26-28];
–GHS Ch 3.4 Respiratory and Skin Sensitization [74], and
–Association of Occupational and Environmental Clinics
Exposure Code List, available from: http://www.aoecdata.org/Default.aspx [75].
Uploading ....