Phthalate Di-butyl phthalate

6. Does DBP pose risks to human health?

• 6.1 Are workers at risk from exposure to DBP?
• 6.2 Are consumers at risk from exposure to DBP?

The human population may be exposed to DBP by swallowing it, by breathing it in, or through skin contact. Risks are assessed by comparing worst case exposures to the exposures at which no harmful effects were observed in animal studies. This gives the margins of safety (MOS). More...

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6.1 Are workers at risk from exposure to DBP?

It is concluded that DBP is of no concern for workers with respect to acute effects, irritation, skin sensitization, carcinogenicity or reproductive toxicity. There is no information on possible respiratory sensitisation. It is concluded that there is at present no need for further information, testing or risk reduction measures beyond those being applied already.

For repeated exposure via skin, it is concluded that for one occupational exposure scenario, the use of products containing DBP in activities involving the use of aerosols, adverse health effects cannot be excluded, the lowest margin of safety being only 3.6. It is concluded that there is a need to limit the risks, taking into account any risk reduction measures that may already be in place. There are no concerns in relation to any other occupational scenarios.

For inhalation exposure, it is concluded there is no concern for health effects in any occupational scenario, except for local effects on the respiratory tract, where the margins of safety are less than 1. For these effects only, it is concluded that there is a need to limit the risks, taking into account any risk reduction measures that may already be in place.

The current occupational exposure limit value for DBP of 5 mg/m³ is higher than the exposures causing local respiratory effects in animals. There is therefore a need to reconsider the current occupational exposure limit. More...

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6.2 Are consumers at risk from exposure to DBP?

For consumers, the margins of safety are sufficiently high for both inhalation and ingestion, so there is no concern.

The margins of safety for inhalation exposure are high and it is concluded that there is no concern for humans indirectly exposed via the environment by inhalation, drinking water or food.

Comparing the maximum infant exposure via breast milk (6 µg/kg bw/day) with the overall oral lowest observed adverse effect level (LOAEL) of 52 mg/kg bw/day, a margin of safety of 8 667 can be calculated. This margin of safety is considered sufficiently high to conclude that there is no concern for breast-fed babies. It is concluded that there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already.

Because DBP is not explosive, flammable or oxidizing, these properties are not considered to pose a hazard to workers. For those properties, there is at present no need for further information and/or testing or for further risk reduction measures beyond those being applied already. More...

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