Rohto V Arctic Cooling Lubricant/Redness Reliever Eye Drops || Skin Deep: Cosmetic Safety Reviews

ROHTO V ARCTIC COOLING LUBRICANT/REDNESS RELIEVER EYE DROPS

last updated: 10/01/09 brand: Rohto by Rohto Pharmaceutical Co. Ltd.

SCORE

moderate hazard (out of 10)

69%

data gap

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94% of eye drops/artificial tears have lower concerns

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), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Occupational hazards

Ingredients from packaging: Active Ingredients: Hypromellose, Tetrahydrozoline Hydrochloride. Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Chlorobutanol, Edetate Disodium, Menthol, Polysorbate 80, Potassium Aspartate, Purified Water, Pyridoxine Hydrochloride, Sodium Borate.

Directions from packaging: Put 1 or 2 drops in the effected eye(s) up to 4 times daily. Use only if imprinted carton overwrap withy Rohto is intact at time of purchase. Store at 20-25 Degrees C (68 - 77 Degrees F) Tightly snap on cap to seal.

Warnings from packaging: For external use only. Ask a doctor if you have narrow angle glaucoma. When using this product: Do not touch tip of container to any surface to avoid contamination. Replace cap after each use. Do not use if solution changes color or becomes cloudy. Overuse may cause more eye redness. Pupils may become temporarily enlarged. Remove contact lenses before using. Stop use and ask a doctor if: you feel eye pain. Changes in vision occur, Redness or irritation of the eyes lasts. Condition worsens or lasts more than 72 hours. Keep out or reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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ingredients

	score	data gap	concerns
BORIC ACID	9	65%	Developmental/reproductive toxicity, Violations, restrictions & warnings, Endocrine disruption, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Occupational hazards
BENZALKONIUM CHLORIDE	7	62%	Violations, restrictions & warnings, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs)
SODIUM BORATE	6	51%	Developmental/reproductive toxicity, Violations, restrictions & warnings, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Occupational hazards
TETRAHYDROZOLINE HYDROCHLORIDE (Active Ingredient)	5	72%	Violations, restrictions & warnings, Neurotoxicity, Organ system toxicity (non-reproductive)
MENTHOL	3	85%	Organ system toxicity (non-reproductive), Multiple, additive exposure sources
PYRIDOXINE HCL PYRIDOXINE HYDROCHLORIDE	3	79%	Developmental/reproductive toxicity, Neurotoxicity
DISODIUM EDTA EDETATE DISODIUM	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
POLYSORBATE-80	2	80%	Developmental/reproductive toxicity
CHLOROBUTANOL	2	73%	Violations, restrictions & warnings
POTASSIUM ASPARTATE	1	93%	none identified
HYDROXYPROPYL METHYLCELLULOSE HYPROMELLOSE (Active Ingredient)	1	88%	none identified
WATER	0	0%	innocuous

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		SODIUM BORATE, BORIC ACID, CHLOROBUTANOL
One or more in vitro tests on mammalian cells show positive mutation results		PYRIDOXINE HCL, POLYSORBATE-80, MENTHOL, DISODIUM EDTA, BENZALKONIUM CHLORIDE

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		DISODIUM EDTA
One or more animal studies show reproductive effects at very low doses		PYRIDOXINE HCL, POLYSORBATE-80
Limited evidence of reproductive toxicity		BORIC ACID, SODIUM BORATE

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		SODIUM BORATE, BORIC ACID, BENZALKONIUM CHLORIDE
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics		BORIC ACID, SODIUM BORATE, BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE
Violation of government restrictions - Banned or found unsafe for use in cosmetics		TETRAHYDROZOLINE HYDROCHLORIDE
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Japan - restricted for use in cosmetics (concentration limit)		CHLOROBUTANOL
Violation of government restrictions - Banned or found unsafe for use in cosmetics		BORIC ACID

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)
One or more animal studies show brain and nervous system effects at high doses		SODIUM BORATE, POLYSORBATE-80
One or more animal studies show brain and nervous system effects at moderate doses		MENTHOL, BORIC ACID
One or more animal studies show brain and nervous system effects at low doses		DISODIUM EDTA, PYRIDOXINE HCL, TETRAHYDROZOLINE HYDROCHLORIDE

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 BORATE, PYRIDOXINE HCL
Human any disruptor - strong evidence		BORIC ACID
One or more animal studies show endocrine disruption at moderate doses		TETRAHYDROZOLINE HYDROCHLORIDE
One or more animal studies show endocrine system disruption at high doses		DISODIUM EDTA

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)
Known human immune system toxicant		BENZALKONIUM CHLORIDE

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)		HYDROXYPROPYL METHYLCELLULOSE
One or more animal studies show sense organ effects at moderate doses (low dose studies may be unavailable for this ingredient)	products for use around the eyes, mouth, or lips	POLYSORBATE-80, CHLOROBUTANOL
One or more animal studies show liver effects at moderate doses (low dose studies may be unavailable for this ingredient)		PYRIDOXINE HCL
One or more animal studies show broad systemic effects at low doses		TETRAHYDROZOLINE HYDROCHLORIDE
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		POTASSIUM ASPARTATE
One or more animal studies show broad systemic effects at low doses		SODIUM BORATE, DISODIUM EDTA
Possible human immune system toxicant		BENZALKONIUM CHLORIDE
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	MENTHOL
One or more animal studies show broad systemic effects at low doses		BORIC ACID

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)
Prohibited for use in food		SODIUM BORATE

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		PYRIDOXINE HCL, POLYSORBATE-80, MENTHOL, HYDROXYPROPYL METHYLCELLULOSE, DISODIUM EDTA, CHLOROBUTANOL
Used in food or as an additive with limited or no toxicity information available		SODIUM BORATE, MENTHOL, BORIC ACID

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		MENTHOL, CHLOROBUTANOL, BORIC ACID
One or more animal studies show skin irritation at low doses		BENZALKONIUM CHLORIDE

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)
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		POLYSORBATE-80, HYDROXYPROPYL METHYLCELLULOSE, DISODIUM EDTA
Not assessed for safety in cosmetics by industry panel		TETRAHYDROZOLINE HYDROCHLORIDE, PYRIDOXINE HCL, POTASSIUM ASPARTATE, MENTHOL, CHLOROBUTANOL

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 low doses		BORIC ACID, SODIUM BORATE

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 moderate doses where the human health implications are not yet well understood		PYRIDOXINE HCL