Tetrachlorophthalic anhydride

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented publication

Data source

Reference

Reference Type:

publication

Title:

Assessment of risk factors for IgE-mediated sensitization to tetrachlorophthalic anhydride.

Author:

Liss GM, Bernstein D, Genesove L, Roos JO, Lim J

Year:

1993

Bibliographic source:

J Allergy Clin Immunol 92: 237-247

Materials and methods

Type of sensitisation studied:

respiratory

Study type:

study with volunteers

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

52 workers were employed in the plant producing solenoid cells with the use of epoxy resin and where a new tetrachlorophthalic anhydride (TCPA) hardener had been introduced in 1988. Serum samples from these workers were assayed for TCPA-human serum albumin-specific IgE and IgG by ELISA.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tetrachlorophthalic anhydride

EC Number:

204-171-4

EC Name:

Tetrachlorophthalic anhydride

Cas Number:

117-08-8

Molecular formula:

C8Cl4O3

IUPAC Name:

tetrachloro-1,3-dihydro-2-benzofuran-1,3-dione

Details on test material:

- Name of test material (as cited in study report): tetrachlorophthalic anhydride

Method

Type of population:

occupational

Subjects:

- Number of subjects exposed: 52
- Other: these workers were employed in the plant producing solenoid cells with the use of epoxy resin and where a new tetrachlorophthalic anhydride (TCPA) hardener had been introduced in 1988. The exposure to TCPA was classified in 4 groups as molders (most directly working with TCPA, n=7), those workers (n=6) intermittently exposed to TCPA (for example, electricians, maintenance workers, supervisors), coil assemblers (n=33), and office workers (n=6).

Route of administration:

inhalation

Details on study design:

TYPE AND DETAILS OF TEST(S) USED
- a cross-sectional evaluation of 52 current workers was conducted
- Other immunological tests: serum samples from 49 workers for TCPA-human serum albumin-specific IgE and IgG by ELISA was assayed.
- Other: Concentrations of TCPA on the day of the cross sectional survey were measured as both personal and area exposures in all manufacturing and front office areas.

Results and discussion

Any other information on results incl. tables

- Mean airborne TCPA concentrations ranged from 0.21 to 0.39 mg/m3 in 1989 and May 1990 but were considerably lower (less than 0.009 to 0.13 mg/m3) by July 1990 when ventilation was introduced.

- There was a high prevalence of reported work-related respiratory symptoms (from 27% to 39%). The mean decline in FEV1 over the shift in the molders (down 4.1%) was significantly different from the change in the office group (increased 2.5%). Intrashift change in FEV1 was inversely correlated with log personal TCPA concentration (r = -0.47).

- Of 49 current workers, 15 (31%) had elevated serum TCPA -human serum albumin-specific IgE antibody levels and 19 (39%) had elevated specific IgG levels. The prevalence of specific IgE was highest in the mold and intermittent groups (54%), in comparison with the coil assembly (25%) and office (0%) groups. Those workers who were IgE positive were significantly less likely to be current smokers and had worked significantly longer since 1988. Of those hired in 1988 or after, the proportion of workers who were IgE positive increased with duration of employment category (p value for trend 0.022).

- Since ventilation was installed and TCPA exposures reduced to less than 0.1 mg/m3, there has been a marked decrease in symptoms and no new cases of occupational asthma among newly hired workers at the plant.