Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation
Type of information:
other: 3rd party hazard and risk assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from Handbook or collection of data

Data source

Reference
Reference Type:
grey literature
Title:
Guidance to ETAD Member Companies on the Implementation of the Code of Ethics
Author:
ETAD
Year:
2008
Bibliographic source:
ETAD Clarastrasse 4 P.0. Box CH-4005 Basel Switzerland

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Data from Handbook or collection of data.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

ETAD guidance - Labelling of reactive dyes

 

Respiratory sensitization potential of some Reactive dyes:

Appropriate MSDS information and hazard labelling

 

ETAD has addressed the concerns that a small percentage of reactive dyes have caused respiratory sensitisation. Based on available knowledge, the possibility that other reactive dyes may also cause respiratory sensitisation cannot be excluded. Because there is at present no suitable animal test system for respiratory sensitisation, ETAD recommends the following:

 

For all Reactive dyes

 

1.    Safety data sheet

 

Information should be given of the possible respiratory sensitisation effects of reactive dyes of all classes. It is the responsibility of each company to determine how this information should be given in accordance with the regulatory requirements in the various countries.

 

2.    Labelling

 

Good working practice requires that Reactive dyes, as indeed all dyes, should be handled carefully to minimise worker exposure. The product label should therefore include a safety phrase that breathing of dust (for solid formulations) or spray (for liquid formulations) should be avoided.

 

In the European Union the appropriate S-phrases must be used, i.e.

 

S22  do not breathe dust

S23  do not breathe spray

 

In the Globally Harmonized System the Precautionary statements for Prevention and Response advice must be used:

 

                Precautionary statements:

                Prevention: Avoid breathing dust and spray

                Response:  If respiratory symptoms occur, seek medical advice

 

 

For listed Reactive dyes

 

There is evidence that certain Reactive dyes have caused respiratory sensitisation in workers occupationally exposed to them. These dyes are listed in the table. For these dyes, and any others which are concluded, on individual assessment, to cause respiratory sensitisation this hazard should be indicated on the safety data sheet and product label.

 

In the European Union the following symbols and phrases must be used.

 

For solid formulations:

Xn      (harmful)

R42    may cause sensitisation by inhalation

S22    do not breathe dust

 

 

For liquid formulations:

Xn      (harmful)

R42    may cause sensitisation by inhalation

S23    do not breathe spray

 

In the Globally Harmonized System these dyes have to be classified as Respiratory Sensitizers

 

Hazard Category         1

Signal word                  Danger

 

Symbol GHS08     

 

Hazard statements:

H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled

Precautionary statements:

P 261 - Avoid breathing dust / mist… (according Physical form of formulation)

P 285 – In case of inadequate ventilation wear respiratory protection

 

 

The substance Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is listed in the "List of Reactive dyes to be classified as respiratory sensitizers" page 31 ff. within that document. Labelling as a respiratory sensitizer is recommended.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Conclusions:
Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is recommended to be labelled as a respiratory sensitizer by ETAD based on international experience gained in handling this dye.
Executive summary:

Reactive Red 065, CAS 70210 -40 -1, EC 274 -437 -2 is recommended to be labelled as a respiratory sensitizer by ETAD based on international experience gained in handling this dye.