Proper Use, Ingredients & Assessment
A Toxicology Risk Assessment was conducted regarding LHAMA, US TRA, CAN TRA & EU TRA June 25, 2020 for Regina's Watercolor Paints (Fuchsia, Rose, Poppy, Sunflower, Daffodil, Aquarium, Delphinium, Blueprint, Violet, Chocolate, Coal, Frost, Storm, Denim, Blueberry, Red Onion, Amethyst, Eggplant, Midnight, Lead, Stone, Aqua, Seashore, Eucalyptus, Mustard, Spring, Avocado, Salal, Olive, Pine, Cattail, Tiger Lily, Tangerine, Sedona, Horchata, Vintage Rose, Grapefruit, Coral, Strawberry, Ruby, Wax Flower, Berry). The below notes are taken from those reports to assist with consumer knowledge. Please send any inquiries to [email protected] for more information.
The product, Regina’s Watercolor Paints, consists of colored paste paint formulations. The product is intended for use by individuals 12 years of age and older for arts and crafts purposes. A toxicology risk assessment was conducted under the assumption that Regina’s Watercolor Paints are intended to be applied using a brush.
Consideration was given to consumer exposure with intended product use and under circumstances involving reasonable foreseeable misuse. Intentional product misuse was not considered within the scope of the assessment. This evaluation was conducted under the assumption that potential acute exposure to product ingredients is through the dermal route and possibly the oral route through accidental ingestion. Chronic exposure is only considered to occur via the dermal route given that chronic accidental ingestion is unlikely. The inhalation route was not evaluated since none of the chemicals in the product formulation were considered sufficiently volatile for inhalation exposure.
LHAMA
Based on the available data, the submitted formulation would not be expected to pose any significant chronic adverse health effects to humans when used as intended or under circumstances involving reasonable foreseeable misuse. Chronic toxicity was evaluated in accordance with the guidelines specified by the Consumer Product Safety Commission in 16 CFR 1500.135. The product will not require any additional chronic health hazard labeling according to ASTM D4236.
TRA (US)
Based on available data, Regina's Watercolor Paints, MEETS the requirements for classification as not toxic (acute/chronic), corrosive, a skin/eye irritant, or a strong sensitizer as defined in 16 CFR 1500.3, when used as intended or under circumstances involving reasonable foreseeable misuse. In addition, the ingredients in the product are not included in the list of banned hazardous substances cited in 16 CFR 1500.17.
Additional Notes [TRA (US)]
• Carbon black (CAS No. 133-86-4) (airborne, unbound particles of respirable size) and titanium dioxide (airborne, unbound particles of respirable size) are listed on the California Proposition 65 List, as chemicals known to the State of California to cause cancer. However, given the nature/physical form of the product (i.e., paste), airborne respirable carbon black and titanium particles would not likely be released from this product and therefore the listed forms of carbon black and titanium dioxide are not relevant for the product.
TRA (CAN)
Based on available data, Regina's Watercolor Paints, MEETS the requirements for classification as not very toxic, toxic or harmful (acute), corrosive, or an irritant based on requirements set forth in the Consumer Chemicals and Containers Regulations, 2001 (SOR/2001-269; as amended), when used as intended or under circumstances involving reasonable foreseeable misuse. Additionally, Regina's Watercolor Paints MEETS the requirements for classification as not toxic (chronic), based on information provided in the Canada Consumer Product Safety Act (S.C. 2010, c. 21). TRA(EU) Based on available data, Regina's Watercolor Paints, is not expected to be: toxic (acute), corrosive or irritating to the skin, damaging or irritating to the eye, sensitizing, mutagenic, carcinogenic, toxic to reproduction or toxic to specific target organs (acute/chronic) as defined in Annex 1, Part 3 (Health Hazards) of regulation 1272/2008/EC concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of substances and mixtures. This evaluation does not constitute a regulatory review or an assessment of compliance with any other EEC directives or regulations.
Data issues or limitations that were identified during the assessment for each ingredient in the product are
discussed below. Additional lines of evidence such as human experience that provide evidence for the
safe use of the ingredient in the product are also described.
LHAMA & TRA (US, CAN & EU)
• Base components of the mixture, Watercolor Medium:
o Assessment of gum arabic powder (CAS No. 9000-01-5) was based on consideration of
available animal data and human experience/use information. Gum arabic powder (listed
as gum arabic) has not been classified for human health hazards by the majority of
industry notifiers according to the European Chemicals Agency’s Classification and
Labelling Inventory database. It should be noted that a significant number of industry
notifiers classified for skin and eye irritation (Category 2), skin and respiratory
sensitization (Category 1), and specific target organ toxicity (single exposure, Category 3
– may cause respiratory irritation). In addition, available data indicate that gum arabic
powder may be a respiratory sensitizer when exposure is via respirable dust. However,
product classification is not warranted for these effects based on a review of the available
data. Gum arabic powder (listed as gum arabic) is listed as a direct food substance
granted generally recognized as safe (GRAS) status by the U.S FDA (21 CFR 184.1330).
Gum arabic powder (listed as Acacia Senegal Gum) is listed in the EU Cosmetic
Ingredients and Substances database with no use restrictions. Gum arabic powder (listed
as acacia senegal gum) is listed in the Health Canada Natural Health Products Ingredients
Database as a non-medicinal ingredient with no use restrictions. Based on the available
information, gum arabic powder is not considered to pose a safety concern at the
concentration present in the product.
o Assessment of honey (CAS No. 8028-66-8) was based on consideration of available
toxicological and human experience/use information. Honey has not been classified for
human health hazards by the majority of notifiers according to the European Chemicals
Agency’s Classification and Labelling Inventory database. According to the Cosmetic
Ingredient Review, honey is considered safe in rinse-off cosmetic products at
concentrations up to 22%. Honey (also listed as mel) is listed in the EU Cosmetic
Ingredients and Substances database with no use restrictions. Honey is listed in the
Health Canada Natural Health Products Ingredients Database as a non-medicinal
ingredient for oral and topical use. Based on the available information, honey is not
considered to pose a safety concern at the concentration present in the product.
o Assessment of the mixture, OX GALL LIQUID, was based on
consideration of the SDS provided by the client as well as a review of the available data
regarding the primary ingredients. OX GALL LIQUID has not
been classified as hazardous according to the Occupational Safety and Health
Administration (OSHA) Hazard Communication Standard (HCS) 29 CFR 1910.1200.
Based on the available information, OX GALL LIQUID, is not
considered to pose a safety concern at the concentration present in the product.
o Clove oil (CAS No. 8000-34-8) is not considered to pose a safety concern given its low
concentration (<0.1%) present in the final product.
• Assessment of Dr. Ph. Martin's Hydrus Fine Art Watercolor mixtures were based on
consideration of the safety data sheet (SDS) provided by the client. Dr. Ph. Martin's Hydrus Fine
Art Watercolor mixtures have not been classified for human health hazards according to the
Globally Harmonized System of Classification and Labelling of Chemicals. It is also noted that
according to the SDS, Dr. Ph. Martin's Hydrus Fine Art Watercolor mixtures have been certified
as non-toxic by a toxicologist of The Arts and Creative Materials Institute (ACMI) and is labelled
with an AP approved seal. Based on the available information, Dr. Ph. Martin's Hydrus Fine Art
Watercolor mixtures are not considered to pose a safety concern at the concentration present in
the product.
The product, Regina’s Watercolor Paints, consists of colored paste paint formulations. The product is intended for use by individuals 12 years of age and older for arts and crafts purposes. A toxicology risk assessment was conducted under the assumption that Regina’s Watercolor Paints are intended to be applied using a brush.
Consideration was given to consumer exposure with intended product use and under circumstances involving reasonable foreseeable misuse. Intentional product misuse was not considered within the scope of the assessment. This evaluation was conducted under the assumption that potential acute exposure to product ingredients is through the dermal route and possibly the oral route through accidental ingestion. Chronic exposure is only considered to occur via the dermal route given that chronic accidental ingestion is unlikely. The inhalation route was not evaluated since none of the chemicals in the product formulation were considered sufficiently volatile for inhalation exposure.
LHAMA
Based on the available data, the submitted formulation would not be expected to pose any significant chronic adverse health effects to humans when used as intended or under circumstances involving reasonable foreseeable misuse. Chronic toxicity was evaluated in accordance with the guidelines specified by the Consumer Product Safety Commission in 16 CFR 1500.135. The product will not require any additional chronic health hazard labeling according to ASTM D4236.
TRA (US)
Based on available data, Regina's Watercolor Paints, MEETS the requirements for classification as not toxic (acute/chronic), corrosive, a skin/eye irritant, or a strong sensitizer as defined in 16 CFR 1500.3, when used as intended or under circumstances involving reasonable foreseeable misuse. In addition, the ingredients in the product are not included in the list of banned hazardous substances cited in 16 CFR 1500.17.
Additional Notes [TRA (US)]
• Carbon black (CAS No. 133-86-4) (airborne, unbound particles of respirable size) and titanium dioxide (airborne, unbound particles of respirable size) are listed on the California Proposition 65 List, as chemicals known to the State of California to cause cancer. However, given the nature/physical form of the product (i.e., paste), airborne respirable carbon black and titanium particles would not likely be released from this product and therefore the listed forms of carbon black and titanium dioxide are not relevant for the product.
TRA (CAN)
Based on available data, Regina's Watercolor Paints, MEETS the requirements for classification as not very toxic, toxic or harmful (acute), corrosive, or an irritant based on requirements set forth in the Consumer Chemicals and Containers Regulations, 2001 (SOR/2001-269; as amended), when used as intended or under circumstances involving reasonable foreseeable misuse. Additionally, Regina's Watercolor Paints MEETS the requirements for classification as not toxic (chronic), based on information provided in the Canada Consumer Product Safety Act (S.C. 2010, c. 21). TRA(EU) Based on available data, Regina's Watercolor Paints, is not expected to be: toxic (acute), corrosive or irritating to the skin, damaging or irritating to the eye, sensitizing, mutagenic, carcinogenic, toxic to reproduction or toxic to specific target organs (acute/chronic) as defined in Annex 1, Part 3 (Health Hazards) of regulation 1272/2008/EC concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of substances and mixtures. This evaluation does not constitute a regulatory review or an assessment of compliance with any other EEC directives or regulations.
Data issues or limitations that were identified during the assessment for each ingredient in the product are
discussed below. Additional lines of evidence such as human experience that provide evidence for the
safe use of the ingredient in the product are also described.
LHAMA & TRA (US, CAN & EU)
• Base components of the mixture, Watercolor Medium:
o Assessment of gum arabic powder (CAS No. 9000-01-5) was based on consideration of
available animal data and human experience/use information. Gum arabic powder (listed
as gum arabic) has not been classified for human health hazards by the majority of
industry notifiers according to the European Chemicals Agency’s Classification and
Labelling Inventory database. It should be noted that a significant number of industry
notifiers classified for skin and eye irritation (Category 2), skin and respiratory
sensitization (Category 1), and specific target organ toxicity (single exposure, Category 3
– may cause respiratory irritation). In addition, available data indicate that gum arabic
powder may be a respiratory sensitizer when exposure is via respirable dust. However,
product classification is not warranted for these effects based on a review of the available
data. Gum arabic powder (listed as gum arabic) is listed as a direct food substance
granted generally recognized as safe (GRAS) status by the U.S FDA (21 CFR 184.1330).
Gum arabic powder (listed as Acacia Senegal Gum) is listed in the EU Cosmetic
Ingredients and Substances database with no use restrictions. Gum arabic powder (listed
as acacia senegal gum) is listed in the Health Canada Natural Health Products Ingredients
Database as a non-medicinal ingredient with no use restrictions. Based on the available
information, gum arabic powder is not considered to pose a safety concern at the
concentration present in the product.
o Assessment of honey (CAS No. 8028-66-8) was based on consideration of available
toxicological and human experience/use information. Honey has not been classified for
human health hazards by the majority of notifiers according to the European Chemicals
Agency’s Classification and Labelling Inventory database. According to the Cosmetic
Ingredient Review, honey is considered safe in rinse-off cosmetic products at
concentrations up to 22%. Honey (also listed as mel) is listed in the EU Cosmetic
Ingredients and Substances database with no use restrictions. Honey is listed in the
Health Canada Natural Health Products Ingredients Database as a non-medicinal
ingredient for oral and topical use. Based on the available information, honey is not
considered to pose a safety concern at the concentration present in the product.
o Assessment of the mixture, OX GALL LIQUID, was based on
consideration of the SDS provided by the client as well as a review of the available data
regarding the primary ingredients. OX GALL LIQUID has not
been classified as hazardous according to the Occupational Safety and Health
Administration (OSHA) Hazard Communication Standard (HCS) 29 CFR 1910.1200.
Based on the available information, OX GALL LIQUID, is not
considered to pose a safety concern at the concentration present in the product.
o Clove oil (CAS No. 8000-34-8) is not considered to pose a safety concern given its low
concentration (<0.1%) present in the final product.
• Assessment of Dr. Ph. Martin's Hydrus Fine Art Watercolor mixtures were based on
consideration of the safety data sheet (SDS) provided by the client. Dr. Ph. Martin's Hydrus Fine
Art Watercolor mixtures have not been classified for human health hazards according to the
Globally Harmonized System of Classification and Labelling of Chemicals. It is also noted that
according to the SDS, Dr. Ph. Martin's Hydrus Fine Art Watercolor mixtures have been certified
as non-toxic by a toxicologist of The Arts and Creative Materials Institute (ACMI) and is labelled
with an AP approved seal. Based on the available information, Dr. Ph. Martin's Hydrus Fine Art
Watercolor mixtures are not considered to pose a safety concern at the concentration present in
the product.
