The risks posed by a substance are determined by both its hazardous properties (potential to cause adverse human health or ecological effects) and the amount or extent of exposure to people or the environment.
When needed, the Government implements risk management measures under CEPA 1999 and other federal acts to help prevent or reduce potential harm.
The Government concluded that tall oil (CAS RN 8002-26-4), specifically on the basis of risk presented by crude tall oil (CTO), is harmful to the environment, but not to human health.
The Government is proposing to include CTO in amendments to the Pulp and Paper Effluent Regulations under the Fisheries Act to risk manage this substance.
The Government also concluded that the other 11 substances in the group of 12 (including the 4 evaluated using the ERC Approach) are not harmful to human health or the environment at levels of exposure considered in the assessment.
There were limited health effects reported for the substances in this group, such as decreased body weight and cellular changes in some organs. Some substances in this group consist of components that could have potential effects on the environment at low exposure concentrations.
About these substances
The screening assessment focused on 12 substances referred to as the Resins and Rosins Group. They were assessed under the third phase of the Chemicals Management Plan (CMP) and are listed below:
1-Phenanthrenecarboxylic acid, 1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-, [1R-(1α,4aβ,10aα)] (DHAA; CAS RN 1740-19-8)
Tall oil [CTO or distilled tall oil (DTO); CAS RN 8002-26-4]
Tall-oil pitch (TOP; CAS RN 8016-81-7)
Storax (balsam) (referred to as storax; CAS RN 8046-19-3)
Rosin (CAS RN 8050-09-7)
Resin acids and rosin acids, hydrogenated, Me esters (RHME; CAS RN 8050-15-5)
Rosin, maleated (RMa; CAS RN 8050-28-0)
Tall-oil rosin (also known as rosin; CAS RN 8052-10-6)
Resin acids and rosin acids, calcium salts (RCa; CAS RN 9007-13-0)
Resin acids and rosin acids, sodium salts (RNa; CAS RN 61790-51-0)
Resin acids and rosin acids, Me esters (RME; CAS RN 68186-14-1)
Resin acids and rosin acids (also known as rosin; CAS RN 73138-82-6)
Under the Domestic Substances List, "tall oil" covers 2 distinct materials usually referred to in Canada as crude tall oil (CTO) and distilled tall oil (DTO).
Substances in the Resins and Rosins Group are naturally occurring in the environment. CTO may serve as a source material for several downstream products, including other substances in the assessment (TOP, rosin, and DTO).
According to information gathered by the Government, these substances may be used in Canada as processing aids, electronics solder, concrete production, rubber compounding, steelmaking and in paints or coatings. They may also be used in products available to consumers such as adhesives, binding agents, cosmetics, natural health products and non-prescription drugs.
Human and ecological exposures
RMa and rosin (CAS RN 8052-10-6) were previously evaluated through the Rapid Screening of Substances with Limited General Population Exposure approach, which determined that further assessment was required. In the Resins and Rosins Group assessment summarized here, it was determined that exposure of the general population to these 2 substances is considered to be negligible.
The screening assessment indicated that Canadians may be exposed to substances in this group through the dermal route (skin contact) from the use of rosin as a gripping agent (by athletes and violinists), as a non-medicinal ingredient in sunscreens, and in cosmetic products (such as moisturizers and cleansers). There is also the potential for oral exposure from other uses, such as in dental varnishes, dental sealants, and lipsticks.
Major sources of exposure to the environment are emissions of these substances from manufacturing and industrial uses in Canada. Releases of concern are primarily to water and ecological scenarios were developed for 8 of the 12 substances (CTO and DTO, TOP, rosin CAS RN 8050-09-7, rosin CAS RN 8052-10-6, RCa, RNa, RMe and RHME).
According to the information considered under the ERC Approach, the remaining 4 of the 12 substances were identified as having low ecological exposure potential (DHAA, storax, RME and rosin CAS RN 731380-82-6).
Key health and ecological effects (hazard)
Limited health effects were reported in studies for the substances in the Resins and Rosins Group, such as decreased body weight and cellular changes in some organs.
Eight of the 12 substances were identified as having potential effects on the environment at low concentrations.
Storax and RME were identified as having a low ecological hazard potential, while DHAA and rosin (CAS RN 731380-82-6) were identified as having moderate and high ecological hazard potential respectively, under the ERC Approach.
Risk assessment outcomes
Using the approaches mentioned above, 3 of the 12 substances (TOP, RMa and rosin CAS RN 8052-10-6) were considered to be a low concern for human health at levels of exposure considered in the assessment.
Based upon comparisons of levels to which Canadians may be exposed to resin and rosin substances, and levels associated with health effects, it was determined that the risk to human health from the remaining 9 of the 12 substances is also considered to be low.
Ecological scenarios were done for 8 of the 12 substances in this group. Based on these, it was determined that only CTO poses a risk to the environment due to its incidental co-production in the kraft pulping process. There was no risk identified for the other 7 substances, including DTO.
Based upon the outcome of the ERC Approach, the 4 remaining substances of the group of 12 are considered unlikely to be causing ecological harm.
Screening assessment conclusions
The Government concluded that the 12 substances in the Resins and Rosins Group are not harmful to human health at levels of exposure considered in the assessment.
However, the Government also concluded that tall oil (CAS RN 8002-26-4) is entering the environment at levels that are harmful to the environment, specifically due to CTO. It was also concluded that the other 11 substances are not entering the environment at levels that are harmful.
Publication of the risk management approach aims to inform stakeholders of proposed risk management actions and continue discussion about their development. The Government will consider the following action to address ecological concerns:
including CTO in amendments to the Pulp and Paper Effluent Regulations (PPER) under the Fisheries Act. Although the CAS RN for "tall oil" covers both CTO and DTO, the concern is with CTO and not DTO.
Risk management actions may evolve through consideration of assessments and risk management actions published for other substances. This is to ensure effective, coordinated, and consistent risk management decision-making.
Although 6 substances in this group (DTO, 3 rosin substances, RCa, and RNa) are not considered to be harmful to human health or the environment at levels of exposure considered in the assessment, these substances are associated with ecological effects of concern. There may be a potential risk if exposure levels were to increase.
For this reason, the Government is considering follow-up activities for these 6 substances, such as including them in future information gathering initiatives, to track changes in use (or quantity) and releases in Canada.