Rohto V for Eyes, Redness Reliever Eye Drops || Skin Deep: Cosmetic Safety Reviews

ROHTO V FOR EYES, REDNESS RELIEVER EYE DROPS

last updated: 04/03/08 brand: Rohto by Rohto Pharmaceutical Co. Ltd.

SCORE

moderate hazard (out of 10)

64%

data gap

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99% 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: NAPHAZOLINE HYDROCHLORIDE 0.012% (REDNESS RELIEVER), POLYSORBATE 80 0.2% (LUBRICANT). INACTIVE INGREDIENTS: ALCOHOL (0.1%), BENZALKONIUM CHLORIDE, BORIC ACID, CHLOROBUTANOL, EDETATE DISODIUM, MENTHOL, PURIFIED WATER, SODIUM BORATE.

Directions from packaging: Retain carton for complete information. Put 1 or 2 drops in the effected eye-s up to 4 times daily. Store at 20 to 25 degrees C - 68 to 77 degrees F. Put 1or 2 drops in the affected eye(s) up to 4 times daily.

Warnings from packaging: For external use only. Ask a doctor before use 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 enlarged temporarily 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 of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Use only if imprinted carton overwrap with ROHTO is intact at time of purchase.

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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
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
NAPHAZOLINE HYDROCHLORIDE (Active Ingredient)	3	75%	Violations, restrictions & warnings
MENTHOL	3	85%	Organ system toxicity (non-reproductive), Multiple, additive exposure sources
DISODIUM EDTA EDETATE DISODIUM	3	78%	Neurotoxicity, Organ system toxicity (non-reproductive), Enhanced skin absorption
POLYSORBATE-80 (Active Ingredient)	2	80%	Developmental/reproductive toxicity
CHLOROBUTANOL	2	73%	Violations, restrictions & warnings
WATER (PURIFIED)	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 on mammalian cells show positive mutation results		BENZALKONIUM CHLORIDE, DISODIUM EDTA, MENTHOL, POLYSORBATE-80
One or more in vitro tests non-mammalian cells show positive mutation results		BORIC ACID, CHLOROBUTANOL, SODIUM BORATE
Cancer - limited evidence		ETHANOL

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

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		SODIUM BORATE, BORIC ACID, BENZALKONIUM CHLORIDE, BENZALKONIUM CHLORIDE, CHLOROBUTANOL
Violation of government restrictions - Banned or found unsafe for use in cosmetics		NAPHAZOLINE HYDROCHLORIDE, 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
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 moderate doses		MENTHOL
One or more animal studies show brain and nervous system effects at high doses		POLYSORBATE-80
One or more animal studies show brain and nervous system effects at low doses		DISODIUM EDTA
One or more animal studies show brain and nervous system effects at moderate doses		BORIC ACID

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)
Human any disruptor - strong evidence		BORIC ACID
One or more animal studies show endocrine system disruption at high doses		DISODIUM EDTA, SODIUM BORATE

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 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 broad systemic effects at low doses		DISODIUM EDTA, SODIUM BORATE, BORIC ACID
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	MENTHOL
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	ETHANOL

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		ETHANOL
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)
Used in food or as an additive with limited or no toxicity information available		MENTHOL, SODIUM BORATE
Designated as safe for general or specific, limited use in food		CHLOROBUTANOL, DISODIUM EDTA, ETHANOL, MENTHOL, POLYSORBATE-80
Used in food or as an additive with limited or no toxicity information available		ETHANOL, 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
One or more animal studies show skin irritation at low doses		BENZALKONIUM CHLORIDE, ETHANOL
One or more animal studies show skin irritation at moderate doses		BORIC ACID, CHLOROBUTANOL

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, DISODIUM EDTA
Not assessed for safety in cosmetics by industry panel		NAPHAZOLINE HYDROCHLORIDE, MENTHOL, ETHANOL, 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		SODIUM BORATE
Allowed workplace exposures restricted to high doses		ETHANOL
Allowed workplace exposures restricted to low doses		BORIC ACID

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		ETHANOL