Notification of proposed amendments to the Poisons Standard in relation to azo dyes
Amendment
It is proposed to amend the Poisons Standard with respect to azo dyes (derivatives by diazotisation) as follows:
Schedule 7 - Amend entry
AZO DYES that are derivatives by diazotisation of any of the following substances:
p-aminoazobenzene (CAS No. 60-09-3)
o-aminoazotoluene (CAS No. 97-56-3)
o-anisidine (CAS No. 90-04-0)
p-chloroaniline (CAS No. 106-47-8)
4-chloro-o-toluidine (CAS No. 95-69-2)
2,4-diaminoanisole (CAS No. 615-05-4)
6-methoxy-m-toluidine (p-cresidine) (CAS No. 120-71-8)
4,4-methylenedianiline (CAS No. 101-77-9)
2-naphthylamine (CAS No. 91-59-8)
5-nitro-o-toluidine (CAS No. 99-55-8)
2,4-toluenediamine (CAS No. 95-80-7)
o-toluidine (CAS No. 95-53-4)
2,4,5-trimethylaniline (CAS No. 137-17-7)
except for BASIC RED 76 (CAS No. 68391-30-0) when included in Schedule 6.
| POISON | STANDARD STATEMENTS |
|---|---|
|
AZO DYES (derivatives by diazotisation) |
A |
|
A: (For advice, contact a Poisons Information Centre (e.g. phone Australia 13 11 26; New Zealand 0800 764 766) or a doctor (at once).) |
|
| POISON | WARNING STATEMENTS | SAFETY DIRECTION |
|---|---|---|
|
AZO DYES (derivatives by diazotisation) |
6 |
5 |
|
Warning statements: 6 (May cause cancer). Safety Directions: 5 (Wear protective gloves when mixing or using). |
||
Reasons for the amendment
- The change to the Poisons Standard entry for 'Azo dyes that are derivatives by diazotisation of any of the following substances' by the inclusion of the two substances (2,4-diaminoanisole (CAS No. 615-05-4) and 4,4-methylenedianiline (CAS No. 101-77-9)), will not increase the risk from the use of products containing these substances. On the contrary, as the proposed amendment seeks to explicitly include these substances under the current Schedule 7 entry, as derivatives of these substances (azo dyes) are considered to be genotoxic and/or carcinogenic, the risk from these substances being used in products as colouring agents or dyes is reduced. Moreover, any benefit from the use of these substances to generate (azo) colouring agents or dyes is considered mute given their carcinogenic potential.
- The available data indicate that both these substances are genotoxic (in vitro & in vivo) and carcinogenic in lifetime studies in mice and rats.
- The scheduling of these azo dyes would achieve greater international alignment. Dyes based on 2,4-diaminoanisole (CAS No. 615-05-4) and 4,4-methylenedianiline (CAS No. 101-77-9) are not permitted to be used in Europe, if the amines are present at detectable concentrations in textile and leather articles that may come into contact with human skin or the oral cavity, owing to potential carcinogenic effects. Furthermore, while azo dyes are limited to a concentration of 30 ppm of the amine in dyed articles by recommendation of the Australian Competition and Consumer Commission (ACCC), the scheduling of these substances would provide complementary protection against hazards associated with the use of these substances in home dyeing.
- The current purpose and extent of use of the substances is limited. However, as the derivatives by diazotisation of these substances would be expected to produce azo compounds, the latter could be expected to be used as colouring agents or dyes based on information on their use internationally.
- Noting that the critical health concern for azo dyes which are derivatives by diazotisation is the production of specific carcinogenic aromatic amines, safety directions and warning statements will be mandated via new Appendix E and Appendix F entries in the Poisons Standard.
Date of effect
1 February 2021