MASTIC SPA MOUTHWASH FLUORIDE (2007 formulation) || Skin Deep: Cosmetic Safety Reviews

MASTIC SPA MOUTHWASH FLUORIDE (2007 FORMULATION)

last updated: 12/01/07 brand: Mastic Spa by Mastic Spa

SCORE

high hazard (out of 10)

80%

data gap

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COMPANY POLICIES

Compact for Safe Cosmetics
Non-signer: This company has not signed the Compact.

Animal Testing Policy
This company's animal testing policy is unknown.

Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to one or more ingredients in this product -- not the product itself -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

Ingredients in this product are linked to:
	Cancer
	Developmental/reproductive toxicity
	Violations, restrictions & warnings
	Allergies/immunotoxicity
	Other concerns for ingredients used in this product: Neurotoxicity, Endocrine disruption, Organ system toxicity (non-reproductive), Miscellaneous, Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Contamination concerns, Occupational hazards, Biochemical or cellular level changes

Note: This product formulation was obtained from the FDA VCRD.

Ingredients from packaging: ALCOHOL, SODIUM LAURYL SULFATE, GLYCERIN, SORBITOL, SODIUM PHOSPHATE, MONOBASIC, DISODIUM PHOSPHATE, FDC BLUE #1, SODIUM FLUORIDE, METHYL SALICYLATE, EUCALYPTOL, THYMOL, SORBIC ACID, MENTHOL, DL-, PEG-40 HYDROGENATED CASTOR OIL, FRAGRANCE, PISTACHIO SEED (PISTACIA VERA) OIL, MASTIC GUM (PISTACIA LENTISCUS), SODIUM SACCHARIN, ANHYDROUS, SODIUM LAUROYL SARCOSINATE

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ingredients

	score	data gap	concerns
SODIUM FLUORIDE	9	63%	Cancer, Developmental/reproductive toxicity, Violations, restrictions & warnings, Neurotoxicity, Endocrine disruption, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Occupational hazards, Biochemical or cellular level changes
FRAGRANCE	8	100%	Neurotoxicity, Allergies/immunotoxicity, Miscellaneous
PEG-40 HYDROGENATED CASTOR OIL	4	75%	Organ system toxicity (non-reproductive), Contamination concerns (ETHYLENE OXIDE, 1,4-DIOXANE, ETHYLENE OXIDE, 1,4-DIOXANE)
THYMOL	6	63%	Violations, restrictions & warnings, Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption, Occupational hazards
ETHANOL ALCOHOL	5	74%	Cancer, Developmental/reproductive toxicity, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Occupational hazards
SODIUM LAUROYL SARCOSINATE	4	73%	Violations, restrictions & warnings, Enhanced skin absorption, Contamination concerns (NITROSAMINES)
METHYL SALICYLATE	4	71%	Developmental/reproductive toxicity, Violations, restrictions & warnings, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
SORBIC ACID	3	80%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
SODIUM LAURYL SULFATE	3	68%	Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
PISTACIA LENTISCUS (MASTIC) GUM MASTIC GUM (PISTACIA LENTISCUS)	2	89%	Multiple, additive exposure sources
FD&C BLUE 1	1	83%	none identified
SODIUM SACCHARIN, ANHYDROUS	2	80%	Neurotoxicity
EUCALYPTOL	2	79%	none identified
GLYCERIN	2	74%	Organ system toxicity (non-reproductive), Occupational hazards
SODIUM PHOSPHATE	1	89%	none identified
SORBITOL	1	88%	none identified
MENTHOL, DL-	1	87%	Organ system toxicity (non-reproductive)
DISODIUM PHOSPHATE	1	86%	none identified
PISTACHIO SEED (PISTACIA VERA) OIL	0	100%	none identified

Cancer*

*This table includes all possible cancer concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more in vitro tests non-mammalian cells show positive mutation results		METHYL SALICYLATE
One or more in vitro tests on mammalian cells show positive mutation results		SODIUM SACCHARIN, ANHYDROUS, THYMOL, SORBITOL, SORBIC ACID, SODIUM LAURYL SULFATE, GLYCERIN, EUCALYPTOL
One or more animal studies show tumor formation at low doses		SODIUM FLUORIDE
Cancer - limited evidence		ETHANOL
Cancer - not classifiable/not likely to be human carcinogen		FD&C BLUE 1

Developmental/reproductive toxicity*

*This table includes all possible developmental/reproductive toxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show reproductive effects at high doses		SODIUM SACCHARIN, ANHYDROUS, SODIUM LAURYL SULFATE
Limited evidence of reproductive toxicity		METHYL SALICYLATE
One or more animal studies show reproductive effects at high doses		EUCALYPTOL
One or more animal studies show reproductive effects at moderate doses		THYMOL, GLYCERIN
Human nervous system toxicant - moderate evidence		SODIUM FLUORIDE
Limited evidence of reproductive toxicity		ETHANOL

Violations, restrictions & warnings*

*This table includes all possible violations, restrictions & warnings concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications		THYMOL, SODIUM LAURYL SULFATE, SODIUM LAUROYL SARCOSINATE, METHYL SALICYLATE, PEG-40 HYDROGENATED CASTOR OIL
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics		SODIUM FLUORIDE, METHYL SALICYLATE, THYMOL, SODIUM LAUROYL SARCOSINATE, SODIUM LAUROYL SARCOSINATE

Neurotoxicity*

*This table includes all possible neurotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
nervous system - weight of evidence unknown/unassessed/unreview: published lit review or major tox study		ETHANOL
One or more animal studies show brain and nervous system effects at high doses		GLYCERIN, FD&C BLUE 1
One or more animal studies show brain and nervous system effects at moderate doses		MENTHOL, DL-, METHYL SALICYLATE, DISODIUM PHOSPHATE, SODIUM LAURYL SULFATE, EUCALYPTOL
One or more animal studies show brain and nervous system effects at low doses		THYMOL
One or more animal studies show brain and nervous system effects at very low doses		SODIUM SACCHARIN, ANHYDROUS
Moderate evidence of human neurotoxicity		FRAGRANCE
Strong evidence of human neurotoxicity		SODIUM FLUORIDE

Endocrine disruption*

*This table includes all possible endocrine disruption concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show endocrine system disruption at high doses		SODIUM LAURYL SULFATE, GLYCERIN, EUCALYPTOL
One or more studies show endocrine system disruption at low doses		SODIUM FLUORIDE
One or more animal studies show endocrine disruption at moderate doses		THYMOL

Allergies/immunotoxicity*

*This table includes all possible allergies/immunotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Human skin toxicant - strong evidence		SORBIC ACID
Known human immune system toxicant		FRAGRANCE

Organ system toxicity (non-reproductive)*

*This table includes all possible organ system toxicity (non-reproductive) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show broad systemic effects at high doses (low dose studies may be unavailable for this ingredient)		PISTACIA LENTISCUS (MASTIC) GUM, SODIUM SACCHARIN, ANHYDROUS, SORBITOL
One or more animal studies show classified as toxic effects at moderate doses (low dose studies may be unavailable for this ingredient)		FD&C BLUE 1
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		SODIUM PHOSPHATE, DISODIUM PHOSPHATE, EUCALYPTOL
Limited evidence of sense organ toxicity		SORBIC ACID
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	ETHANOL
One or more animal studies show gastrointestinal effects at very low doses		SODIUM FLUORIDE
Limited evidence of sense organ toxicity		PEG-40 HYDROGENATED CASTOR OIL
One or more animal studies show broad systemic effects at low doses		THYMOL, SODIUM LAURYL SULFATE
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	MENTHOL, DL-, METHYL SALICYLATE
One or more animal studies show kidney or renal system effects at very low doses		GLYCERIN

Miscellaneous*

*This table includes all possible miscellaneous concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Occupational hazards related to handling		THYMOL, ETHANOL, SODIUM FLUORIDE
Ingredient not fully labeled - identity unknown		FRAGRANCE

Multiple, additive exposure sources*

*This table includes all possible multiple, additive exposure sources concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Designated as safe for general or specific, limited use in food		MENTHOL, DL-, SODIUM SACCHARIN, ANHYDROUS, THYMOL, SORBITOL, SORBIC ACID, SODIUM PHOSPHATE, SODIUM LAURYL SULFATE, SODIUM FLUORIDE, PEG-40 HYDROGENATED CASTOR OIL, METHYL SALICYLATE
Used in food or as an additive with limited or no toxicity information available		ETHANOL, SODIUM FLUORIDE, PISTACIA LENTISCUS (MASTIC) GUM
Designated as safe for general or specific, limited use in food		DISODIUM PHOSPHATE, ETHANOL, EUCALYPTOL, FD&C BLUE 1, GLYCERIN

Ecotoxicology*

*This table includes all possible ecotoxicology concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Suspected to be an environmental toxin		SODIUM LAURYL SULFATE
Not suspected to be an environmental toxin		ETHANOL
Wildlife and environmental toxicity		THYMOL

Irritation (skin, eyes, or lungs)*

*This table includes all possible irritation (skin, eyes, or lungs) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show skin irritation at moderate doses		THYMOL, GLYCERIN, DISODIUM PHOSPHATE
One or more animal studies show skin irritation at low doses		ETHANOL
One or more animal studies show skin irritation at very low doses		SORBIC ACID, SODIUM LAURYL SULFATE, METHYL SALICYLATE

Data gaps*

*This table includes all possible data gaps concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Missing safety data noted by cosmetic industry review		THYMOL
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		SORBIC ACID
Not assessed for safety in cosmetics by industry panel		SODIUM SACCHARIN, ANHYDROUS, PISTACHIO SEED (PISTACIA VERA) OIL, MENTHOL, DL-, PISTACIA LENTISCUS (MASTIC) GUM, SORBITOL, SODIUM PHOSPHATE, GLYCERIN, ETHANOL, FRAGRANCE, EUCALYPTOL, DISODIUM PHOSPHATE

Occupational hazards*

*This table includes all possible occupational hazards concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Allowed workplace exposures restricted to very low doses		SODIUM FLUORIDE
Allowed workplace exposures restricted to low doses		THYMOL
Allowed workplace exposures restricted to moderate doses		GLYCERIN
Allowed workplace exposures restricted to high doses		ETHANOL

Biochemical or cellular level changes*

*This table includes all possible biochemical or cellular level changes concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show biochemical changes at high doses where the human health implications are not yet well understood		GLYCERIN, ETHANOL
One or more animal studies show biochemical changes at moderate doses where the human health implications are not yet well understood		SODIUM LAURYL SULFATE, METHYL SALICYLATE, EUCALYPTOL
One or more animal studies show biochemical changes at very low doses where the human health implications are not yet well understood		SODIUM FLUORIDE