In order for the industry to avoid a constant stream of such changes throughout the year, the Agency intends to carry out this process in the form of an 'amended' reassessment, at least annually, in accordance with section 63A of the HSNO Act for changes that are more than "minor" and therefore cannot be made under section 67A of the Act. It should be noted that many of the substances with the proposed changes are widely used and found in many products (eg ethanol). The Agency therefore intends to ensure that as many interested parties in the field of hazardous substances as possible are informed of the application and are given a reasonable opportunity to submit views or comments.
This includes any product that has been approved under Part 5 of the Act and any product that has been assessed by the agency's "status of substance" (SOS) process and requires a legal change in classification. ERMA New Zealand will contact applicants of affected products who have been through the SOS process to make them aware of the proposed changes. The addition of a hazard considered to be a dangerous good (DG) (as prescribed in the UN Model Regulations for the Transport of Dangerous Goods1) can have a significant effect on the handling of the substance.
In most cases where the proposed change will result in the substance being regulated as a DG, the substance will already be handled as a DG internationally. All changes to the classification entail the need for changes to safety data sheets and often labeling requirements.
SECTION SIX – MISCELLANEOUS
A glossary of scientific and technical terms used in the application
- Not applicable
Other information considered relevant to this application not already included
- None
SECTION SEVEN – SUMMARY OF PUBLIC INFORMATION
- Name of the substance for the public register
- Purpose of the application for the public register
- Executive summary
- The reassessment is confined to the issues listed in Appendix 3 and Appendix 4 of the application
- Submission Form
All entries will be recognized by ERMA New Zealand and a summary of the entries will be sent to anyone requesting a copy. For those who do not consent to the disclosure of personal data, the name of the organization is listed, if provided.
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Note
Substance Name CAS Number (if
Issue/Comments
Supporting Information
Approval Number Substance Name
DRAFT
Application Form (HS??)
Substances for reassessment
E(oral), 6.3A, 6.4A
In humans, due to the larger particle size, one would expect much of the dust to be deposited in the upper respiratory tract and then continue into the stomach via the mucociliary fluid pedal, but there is a possibility that smaller particles reach the lower respiratory tract. which justifies a cautious approach. The LC50 is expected to be higher than the LC40, so the LC50 value may not trigger the 6.1A classification. If there is no rat LC50 value, it is acceptable to take the mouse LC50 value, even if the rat LC40 value were extrapolated to the LC50 value, this value would probably be around 0.05 mg/l.
Therefore, it is considered that the weight of evidence is such that the LC50 for this chemical is in the region of 0.05 mg/L, giving rise to a classification of 6.1B instead of 6.1A. Oral LD50 values vary with the vehicle, with the highest values associated with the use of corn oil (EHC 142, 1992). Corn oil is a commonly used vehicle for oral LD50 studies, and in the absence of information indicating that corn oil studies are invalid, the lowest rat LD50 value should be used.
C, 9.4A Suspension concentrate
This substance has a specific UN number 2865 Class 8 PG III We should not have a classification that conflicts with.
B (dermal), 6.3A, 6.4A
Although classification as 6.1B based on LD50 values does not seem justified for this substance, given that there is evidence from human experience and a UN PGII has been listed based on expert judgement, it is recommended that there be a 6.1B classification. Classification 9.3A should also be added based on RTECS data for wild birds LD5033 mg/kg. A gas at >26% in a gas mixture will still oxidize, so classification 5.1.2A should be used for the substance.
Based on several data sheets indicating R-phases equivalent to 6.1B classification, based on a weight of evidence approach, a 6.1B (all) classification should be assigned based on a precautionary approach. Data indicate that the flash point of this substance is 18°C with an IPB of 130-133°C, which supports a 3.1B rather than 3.1C classification. Data indicate that the flash point of this substance is 19.4°C with an IPB of 120-124°C, which supports a 3.1B instead of 3.1C classification.
Data indicates that the flash point of this material is in the range of 25-32°C, supporting a rating of 3.1C rather than 3.1B. Classification changes are based on new data from the HERA Human and Environmental Risk Assessment on Ingredients of European Household Cleaning Products Phosphonates report http://www.heraproject.com/files/30-F-04-. 20HERA%20Phosphonates%20Full%20web%20wd.pdf, the original classifications were based on limited data from the internet available at the time of classification.
Test data do not indicate reproductive/developmental toxicity of the acid, so it is recommended that 6.8B. Based on this information, a diluent will never have a 6.1E classification unless it contains 100% active substance. Active must have a concentration > 7.4% to trigger classification 6.1D (inhalation) based on the following if Tmix (inhalation) > 5 g/L.
On this basis it is assumed that the substance description should change to methylene dipheyl diisocyanate > in a non-hazardous diluent, as the classification will change if the active substance has a different concentration. It appears that the 9.3C was added in error as this substance has no 6.1 data to support this classification and its parent does not have 9.3 classifications. Split the approval into three based on the number or EO Adjust the classifications based on the CESIO document Polyethylene glycol nonyl phenyl ether is a non-ionic surfactant (CAS 9016-45-9).
However, polyethylene glycol nonylphenyl ether current skin and eye irritation classifications were not based on this. Based on information from Alanwood Compendium of Pesticide Common Names for CAS The ISO common name guazatine was originally given to this substance, but the definition of guazatine was later changed when it became known that the commercial substance was a complex reaction product that both than several other active compounds." Therefore, the substance description for CAS 13516-273 should be iminoctadine, not guasatin.
B, 9.1A Methyltrioctylammonium
Limonene occurs as the d and l isomers, and the dl-limonene racemic mixture is known as dipentene. Based on the following new data, Thiacloprid, CAS should be classified as 9.3A due to its toxicity to birds. Thiocloprid does not have individual approval, but the listed substances are affected by the change in the classification of thiacloprid.
Following this approval, the classification of one of the ingredients (carbendazim) was changed, adding 6.6A and 6.8A. After 2002, there was also a change in policy (according to GHS) regarding the assignment of 6.9A/6.9B classifications in mixtures when 6.9A components were present at < 10%. This change meant that the 6.9A classification originally assigned to Taratek GC would be downgraded to 6.9B, as the concentration of each component is 6.9A < 10%.
The Agency's assessment assessed the risks of widespread use on the ground and aerial application. As a result of this assessment, the Authority has put in place controls to mitigate specific risks to public health and the environment from the substances, in particular when applied from the air. At initial approval, the risks of Maxforce Fire Ant Killer and Bait are associated with 10g/kg hydramethylnon.
This issue was raised by the Agency in the Evaluation and Review Report for Campaign and Amdro. In its review, the Authority agreed that it should initiate a reassessment to apply similar controls to previously approved ant baits containing hydramethylnon through a reassessment under section 63A. No person may apply [substance] by air unless that person first obtains a permit from the Authority under section 95A of the Hazardous Substances and New Organisms Act 1996 Any person who applies [substance] by land means at a place in to which the public normally has access must ensure that signs are placed in accordance with section 5.3.1 and Annex M3 of NZS 8409:2004 Management of Aggressive Chemicals [Substance] shall not be applied in or over water.
During the evaluation of HSR06142 (liquid bromatrol and liquid bait containing 0.06 g/l bromadiolone), data were identified indicating that 9.3A classification should apply. Application of the additivity mixing rule using acute oral mammalian data as described under Subclass 6.1 results in a calculated LD50 that does not trigger the threshold for Subclass 9.3. Noting that the criteria for a 9.3A classification is an acute avian or mammalian LC50 £500 ppm in the diet, these dietary studies suggest that a 9.3A.
Confidential substances for reassessment
