Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Justification:
.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Because no acute toxicity hazard (leading to classification and labelling) has been identified, a DNEL for acute exposure is not derived. Various cohort and case-control studies did not show an increase in lung cancer risk in carbon black production workers. Cohort mortality studies of workers exposed to carbon black in the UK found an excess of lung cancer in some, but not all factories included in the study, but there was no association between duration of carbon black exposure and risk of lung cancer mortality, nor were possible confounders such as smoking or past occupational histories taken into account. Newer studies did not find an association between carbon black exposure and lung cancer. Overall, there is inadequate evidence in humans for the carcinogenicity of carbon black. This view is consistent with the most recent IARC evaluation of carbon black.

The critical human health effect is upon the airways. Large multi-centre studies in Europe by Gardiner et al. (1993, 2001) and in the USA by Harber et al. (2003) demonstrate that long-term heavy occupational carbon black exposure is associated with reductions in the forced expiratory volume in 1 second (FEV1). These data indicate that there would be minimal, non-adverse effects on lung function parameters after 40 years of exposure to 1.0 mg/m3 (inhalable fraction, 8-hr TWA). A working lifetime of 40 years to inhalable carbon black at 1 mg/m3 (8-hour TWA) would lead to a mean decrease in FEV1 of 49 mL based on the European study. The comparable study in US carbon black-production workers resulted in a decrease in FEV1 of 28 mL for this exposure and duration scenario. These may be compared to the average age-related FEV1 loss in adult males of about 1,200 ml over this same 40-year period. These studies also demonstrated that carbon black exposure is NOT associated with significant consistent reductions in the forced vital capacity.

Longitudinal follow-up from 1987-1995 of the multi-plant European cohort (van Tongeren et al. 2002) and long-term follow-up of persons with minor radiographic abnormalities over 25 years in one US plant (Harber et al. 2003) do not show progression to advanced pneumoconiosis. The paucity of high profusion radiographic findings, the absence of progression to extensive radiographic abnormality, and the absence of restrictive physiologic abnormalities show that carbon black does not lead to a fibrotic pneumoconiosis in humans.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

There is negligible exposure of the general population to carbon black; carbon black, as is, is not sold to the general public. Further, in consumer articles, it is bound into a matrix without the possibility of release.