Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The Following DN(M)ELs are not necessary to derive for 1 -10 tonnes level:

DN(M)EL for acute/short-term exposure-systemic effects.

DN(M)EL for acute/short-term exposure-local effects.

DN(M)EL for long-term exposure-systemic effects.

DN(M)EL for long-term exposure-local effects.

However, there is helpful information existed for futher risk assessment.

It was found that BDP was of very low acute oral toxicity (LD50 >2 000 mg/kg) and low acute dermal toxicity (LD50 >2 000 mg/kg) in rats. It was non-irritating to rabbit skin and eye and non-sensitising to guinea pig skin. In a 28-day repeat dose oral toxicity study in rats allowed an NOAEL of 1 000 mg/kg/day (highest dose tested) to be clearly established. It was not mutagenic in bacteria, nor did it induce an increased incidence of chromosomal aberrations in Chinese hamster lung cells in vitro. In vivo tests were not provided.

Based on the above studies, BDP is not considered to be a hazardous substance and will not require labelling with specific risk phrases.

Occupational Health and Safety

Transport and Storage

Exposure to the BDP is not expected during transport or storage as long as the packaging remains intact. The risk of adverse health effects for transport and storage workers is considered to be low.

Formulation of Resin Granules

In the event that the liquid chemical is imported for processing into formulated resin granules, dermal exposure by workers opening drums, connecting and disconnecting suction pumps during transfer operations may occur. The blending and extrusion processes are described as enclosed and automated, therefore further exposure would be limited. Workers involved in bagging of resin granules would have low exposure since after heat-melt processing, the chemical is encapsulated within the resin granules. The production facilities are fitted with vacuum extraction equipment to trap fugitive dust and vapour emissions and with bunding to contain liquid spills and leaks. All workers involved in the production of resin granules will wear protective equipment including gloves, safety glasses and overalls. Based on the extensive use of engineering controls such as enclosure and local

exhaust ventilation, and the low toxicity of the chemical, the health risk to workers is low during the formulation process.

End-Use

The preparation of the moulded and extruded finished articles from resin granules is performed in purpose built facilities fitted with vacuum extraction equipment, to minimise release of fugitive particulate material. There is potential for skin contact when opening bags and charging the resin product into the injection-moulding equipment. However, worker exposure is considered negligible since the chemical is encapsulated within the resin granules. The potential for inhalation and eye exposure is low because the chemical is presented as plastic granules resistant to abrasion. Workers handling the chemical will wear protective equipment including gloves, safety glasses, overalls and face shield when necessary. Occupational exposure to the chemical cannot occur before or after the articles are made since the BDP is encapsulated within the finished plastic

articles. In this form, the chemical is not bioavailable, hence health risk to workers is expected to be negligible.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The Following DN(M)ELs are not necessary to derive for 1 -10 tonnes level:

DN(M)EL for acute/short-term exposure-systemic effects.

DN(M)EL for acute/short-term exposure-local effects.

DN(M)EL for long-term exposure-systemic effects.

DN(M)EL for long-term exposure-local effects.

However, there is helpful information existed for futher risk assessment.

The BDP was of very low acute oral toxicity (LD50 >2 000 mg/kg) and low acute dermal toxicity (LD50 >2 000 mg/kg) in rats. It was non-irritating to rabbit skin and eye and non-sensitising to guinea pig skin. In a 28-day repeat dose oral toxicity study in rats allowed an NOAEL of 1 000 mg/kg/day (highest dose tested) to be clearly established. The chemical was not mutagenic in bacteria, nor did it induce an increased incidence of chromosomal aberrations in Chinese hamster lung cells in vitro. In vivo tests were not provided.

Based on the above studies, the chemical is not considered to be a hazardous substance and will not require labelling with specific risk phrases.

Public exposure to the chemical is likely to be widespread, as consumer and automotive plastics containing the chemical will be sold to the public. Once the formulated resin blend containing the chemical is formed into plastic products, it is encapsulated within the resin matrix of the plastic, rendering the chemical biologically unavailable. Consequently, the potential for public exposure to the chemical throughout all phases of its life cycle is considered to be low. Based on this information, it is considered that the chemical will not pose a significant hazard to public health when used in the proposed manner.

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