Summary Report: NA/399

Mexoryl SX Active Ingredient

L'Oreal Paris of 256 Bay Road SANDRINGHAM VICTORIA 3191 has applied for an assessment certificate for the importation of the chemical, Mexoryl SX Active Ingredient, under the Act. Mexoryl SX Active Ingredient is intended to be used as a component of sunscreens and moisturisers. It will be imported at a rate of 1 000 kg per annum

Physical and Chemical Properties

At room temperature and pressure the notified chemical (as a 33% aqueous solution) is a practically odourless brownish liquid. The chemical is not explosive it will react with strong bases and strong oxidants. On combustion the chemical may release carbon and sulphur oxides. It has the following physico-chemical properties: boiling point, 100^oC (as a 33% aqueous solution); density, 1 120 kg/m³; vapour pressure, 2.99 kPa at 25^oC; totally soluble in water; partition coefficient, log P = -1.08 at 22^oC; fat solubility, 3.71 mg/100g at 37^o±0.5^oC; flash point, > 102^oC; autoignition temperature, > 300^oC.

Assessment of Toxicological Data

This assessment is based on report summaries only; full reports have not been sighted which is acceptable as this submission is in the limited category.

In acute oral studies with rats using the acid moiety, triethalanoamine, sodium and potassium salts, acute toxicity was found to be low with respective LD₅₀ > 1 835, > 2 092, > 2 092 and > 2 092 mg/kg. There was no evidence of systemic toxicity or abnormalities at necropsy. The acute dermal toxicity of the acid to rats was low with an LD₅₀ > 1 637 mg/kg. In a 90-day oral repeat dose study in rats, no dose related effects were found at 300 mg/kg/day. At

1 000 mg/kg/day there was phosphoremia in males at week 4 and decreased protein, albumin and globulin levels in females at week 13. There was some evidence of variation in thyroid weight in the male animals fed the test article, however, there was some doubt as to validity of this observation as the control animals were found to have unusually low thyroid weights. Follow up 21-day studies using the triethalanoamine and sodium salts (not audited) on thyroid metabolism found no treatment related changes at dose rates of 305 mg/kg and 444mg/kg respectively.

Skin irritation studies in rabbits found that the triethalanoamine, sodium and potassium salts were non irritant when 0.5 ml of a 10.4% aqueous solution was applied to exposed rabbit skin. A similar study using a 36.7% aqueous solution of the test chemical gave similar results. A stronger solution may produce irritant effects due to the strongly acidic nature of the notified

Ocular irritation tests indicated that all three salts were irritants when 0.1 ml of a 10.5% test solution of each salt was applied to the eyes of rabbits. The potassium salt had the highest index score of 8 out of a possible 110. Ocular irritation studies using the acid were not performed due to the inevitable results.

In teratogenic studies using the triethalanoamine salt in rats, no effects were found at doses up to 300 mg/kg/day. Genotoxicity studies using the triethalanoamine salt and Salmonella typhimurium at doses up to 43 306 micro.g/plate, with or without rat liver S9, found no mutagenic effects. In additional studies using Escherichia coli at doses up to 5 000 micro.g/ plate, with or without rat liver S9, no mutagenic effects were found. Other genotoxicity tests both in vivo chemical. Skin sensitisation tests using guinea pigs gave negative results with both the triethalanoamine salt (10.4% aqueous solution) and the acid (1% solution).

On the basis of the strongly acidic nature of the test chemical it is classified as hazardous. The toxicological studies summarised above indicate that the neutralised acid and potassium salts produce minimal indications of toxicity in a wide range of tests with the exception of rabbit eye irritation studies. It is probable that the neutralised acid, potassium and sodium salts of the notified chemical would be classified as hazardous due to the irritation effects found in the rabbit eye studies. The index scores have not been specified for corneal opacity, iris lesion, conjunctival erythema or oedema; a cautionary irritant classification on the basis of the overall index scores has been assigned, ie hazardous. Eye irritation studies using the acid were not performed due to the corrosive nature of the acid.

Assessment of Public and Occupational Exposure and Health and Safety Effects

The notified chemical will be imported as Mexoryl SX, an aqueous solution containing 33+1% of the notified chemical. The chemical is highly acidic (pH of 1) and is classified as Class 8 dangerous goods under the Australian Code for the Transport of Dangerous Goods. Occupational exposure during transport and warehousing may occur through accidental spillage, however, this will be minimised due to the limited amount transported at any one time (240kg) and the individual container size (30kg).

Occupational exposure will be greatest during reformulation. A total of five staff will be potentially exposed during reformulation. These are a storeman, laboratory technician, compounder and linefiller.

The main pathways for occupational exposure will be via the eyes and skin. As the notified chemical has a low vapour pressure, inhalational exposure is unlikely. Inhalational exposure however may occur if mists or sprays are generated during the formulation of suncreams and moisturisers, for instance if mixing systems are pressurised. The final products, suncream and moisturiser, will contain a maximum of 3.96% and 0.6% of the notified chemical respectively.

There is negligible potential for public exposure to the notified substance arising from importation, storage, transportation and formulation into sunscreen and moisturiser products. There will be extensive public exposure from the end-use application of the chemical as a sunscreen agent and skin moisturiser component, but the notified substance is at a low concentration (3.96% and 0.6% respectively) in these products. There appears to be little dermal absorption following contact; however there is a risk of eye irritation as the agent is a severe irritant in the undiluted form due to its low pH. This hazard is mitigated by the formulation of pH neutral end products.

The notified chemical is classified as hazardous as it is strongly acidic and therefore corrosive.

Assessment of Environmental Fate

Mexoryl SX is intended for use in sunscreens and moisturisers and, as such, would be expected to be released to the environment via consumer use through washing the residual chemical (assumed to be 100% of that applied) off the skin and into the sewerage system. The ready biodegradability of the notified chemical was assessed by the 'Closed Bottle' method (OECD TG 301D). It cannot strictly be termed as readily biodegradable, although its inherent biodegradability is uncertain.

No bioaccumulation of the chemical is expected because its very high water solubility and low octanol/water partition coefficient.

Assessment of Environmental Effects

Ecotoxicity studies were conducted using Mexoryl SX. These indicate the chemical is practically non-toxic to fish and Daphnia.

Assessment of Environmental Hazard

Release of the notified chemical to the environment may occur as a result of formulation and use of cometic products in which it is used (sunscreens and moisturisers). As a worst case, an environmental concentration of 1 ppb is predicted if all the imported chemical remains dissolved in sewage waters (assuming: 1 tonne maximum annual use, an Australian population of 17 million and a daily per capita waste water discharge of 150 L). However, its widespread use, and its expected low toxicity indicate that the overall environmental hazard of the chemical can be rated as negligible.

Recommendations

To minimise occupational exposure to Mexoryl SX Active Ingredient the following guidelines and precautions should be observed.

When using the notified chemical (as the imported formulation) the following protective equipment should be worn:
- impervious gloves conforming to Australian Standards (AS) AS 2161,
- protective eye goggles conforming to AS 1336, and Australian/New Zealand Standards (AS/NZS) 1337
- protective clothing conforming to AS 3765.2, and
- protective footwear conforming to AS/NZS 2210.
Good personal hygiene practices should be observed.
A copy of the Material Safety Data Sheet (MSDS) should be easily accessible to employees.

Download a copy of the Full Public Report NA399 in .pdf format
You will need the free Acrobat Reader to view it

[To Index]



	Summary Report: NA/399 Mexoryl SX Active Ingredient L'Oreal Paris of 256 Bay Road SANDRINGHAM VICTORIA 3191 has applied for an assessment certificate for the importation of the chemical, Mexoryl SX Active Ingredient, under the Act. Mexoryl SX Active Ingredient is intended to be used as a component of sunscreens and moisturisers. It will be imported at a rate of 1 000 kg per annum Physical and Chemical Properties At room temperature and pressure the notified chemical (as a 33% aqueous solution) is a practically odourless brownish liquid. The chemical is not explosive it will react with strong bases and strong oxidants. On combustion the chemical may release carbon and sulphur oxides. It has the following physico-chemical properties: boiling point, 100^oC (as a 33% aqueous solution); density, 1 120 kg/m³; vapour pressure, 2.99 kPa at 25^oC; totally soluble in water; partition coefficient, log P = -1.08 at 22^oC; fat solubility, 3.71 mg/100g at 37^o±0.5^oC; flash point, > 102^oC; autoignition temperature, > 300^oC. Assessment of Toxicological Data This assessment is based on report summaries only; full reports have not been sighted which is acceptable as this submission is in the limited category. In acute oral studies with rats using the acid moiety, triethalanoamine, sodium and potassium salts, acute toxicity was found to be low with respective LD₅₀ > 1 835, > 2 092, > 2 092 and > 2 092 mg/kg. There was no evidence of systemic toxicity or abnormalities at necropsy. The acute dermal toxicity of the acid to rats was low with an LD₅₀ > 1 637 mg/kg. In a 90-day oral repeat dose study in rats, no dose related effects were found at 300 mg/kg/day. At 1 000 mg/kg/day there was phosphoremia in males at week 4 and decreased protein, albumin and globulin levels in females at week 13. There was some evidence of variation in thyroid weight in the male animals fed the test article, however, there was some doubt as to validity of this observation as the control animals were found to have unusually low thyroid weights. Follow up 21-day studies using the triethalanoamine and sodium salts (not audited) on thyroid metabolism found no treatment related changes at dose rates of 305 mg/kg and 444mg/kg respectively. Skin irritation studies in rabbits found that the triethalanoamine, sodium and potassium salts were non irritant when 0.5 ml of a 10.4% aqueous solution was applied to exposed rabbit skin. A similar study using a 36.7% aqueous solution of the test chemical gave similar results. A stronger solution may produce irritant effects due to the strongly acidic nature of the notified Ocular irritation tests indicated that all three salts were irritants when 0.1 ml of a 10.5% test solution of each salt was applied to the eyes of rabbits. The potassium salt had the highest index score of 8 out of a possible 110. Ocular irritation studies using the acid were not performed due to the inevitable results. In teratogenic studies using the triethalanoamine salt in rats, no effects were found at doses up to 300 mg/kg/day. Genotoxicity studies using the triethalanoamine salt and Salmonella typhimurium at doses up to 43 306 micro.g/plate, with or without rat liver S9, found no mutagenic effects. In additional studies using Escherichia coli at doses up to 5 000 micro.g/ plate, with or without rat liver S9, no mutagenic effects were found. Other genotoxicity tests both in vivo chemical. Skin sensitisation tests using guinea pigs gave negative results with both the triethalanoamine salt (10.4% aqueous solution) and the acid (1% solution). On the basis of the strongly acidic nature of the test chemical it is classified as hazardous. The toxicological studies summarised above indicate that the neutralised acid and potassium salts produce minimal indications of toxicity in a wide range of tests with the exception of rabbit eye irritation studies. It is probable that the neutralised acid, potassium and sodium salts of the notified chemical would be classified as hazardous due to the irritation effects found in the rabbit eye studies. The index scores have not been specified for corneal opacity, iris lesion, conjunctival erythema or oedema; a cautionary irritant classification on the basis of the overall index scores has been assigned, ie hazardous. Eye irritation studies using the acid were not performed due to the corrosive nature of the acid. Assessment of Public and Occupational Exposure and Health and Safety Effects The notified chemical will be imported as Mexoryl SX, an aqueous solution containing 33+1% of the notified chemical. The chemical is highly acidic (pH of 1) and is classified as Class 8 dangerous goods under the Australian Code for the Transport of Dangerous Goods. Occupational exposure during transport and warehousing may occur through accidental spillage, however, this will be minimised due to the limited amount transported at any one time (240kg) and the individual container size (30kg). Occupational exposure will be greatest during reformulation. A total of five staff will be potentially exposed during reformulation. These are a storeman, laboratory technician, compounder and linefiller. The main pathways for occupational exposure will be via the eyes and skin. As the notified chemical has a low vapour pressure, inhalational exposure is unlikely. Inhalational exposure however may occur if mists or sprays are generated during the formulation of suncreams and moisturisers, for instance if mixing systems are pressurised. The final products, suncream and moisturiser, will contain a maximum of 3.96% and 0.6% of the notified chemical respectively. There is negligible potential for public exposure to the notified substance arising from importation, storage, transportation and formulation into sunscreen and moisturiser products. There will be extensive public exposure from the end-use application of the chemical as a sunscreen agent and skin moisturiser component, but the notified substance is at a low concentration (3.96% and 0.6% respectively) in these products. There appears to be little dermal absorption following contact; however there is a risk of eye irritation as the agent is a severe irritant in the undiluted form due to its low pH. This hazard is mitigated by the formulation of pH neutral end products. The notified chemical is classified as hazardous as it is strongly acidic and therefore corrosive. Assessment of Environmental Fate Mexoryl SX is intended for use in sunscreens and moisturisers and, as such, would be expected to be released to the environment via consumer use through washing the residual chemical (assumed to be 100% of that applied) off the skin and into the sewerage system. The ready biodegradability of the notified chemical was assessed by the 'Closed Bottle' method (OECD TG 301D). It cannot strictly be termed as readily biodegradable, although its inherent biodegradability is uncertain. No bioaccumulation of the chemical is expected because its very high water solubility and low octanol/water partition coefficient. Assessment of Environmental Effects Ecotoxicity studies were conducted using Mexoryl SX. These indicate the chemical is practically non-toxic to fish and Daphnia. Assessment of Environmental Hazard Release of the notified chemical to the environment may occur as a result of formulation and use of cometic products in which it is used (sunscreens and moisturisers). As a worst case, an environmental concentration of 1 ppb is predicted if all the imported chemical remains dissolved in sewage waters (assuming: 1 tonne maximum annual use, an Australian population of 17 million and a daily per capita waste water discharge of 150 L). However, its widespread use, and its expected low toxicity indicate that the overall environmental hazard of the chemical can be rated as negligible. Recommendations To minimise occupational exposure to Mexoryl SX Active Ingredient the following guidelines and precautions should be observed. When using the notified chemical (as the imported formulation) the following protective equipment should be worn: - impervious gloves conforming to Australian Standards (AS) AS 2161, - protective eye goggles conforming to AS 1336, and Australian/New Zealand Standards (AS/NZS) 1337 - protective clothing conforming to AS 3765.2, and - protective footwear conforming to AS/NZS 2210. Good personal hygiene practices should be observed. A copy of the Material Safety Data Sheet (MSDS) should be easily accessible to employees. Download a copy of the Full Public Report NA399 in .pdf format You will need the free Acrobat Reader to view it [To Index]

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