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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Sensitisation data (human)

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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: Limited documentation, mixed exposure

Data source

Reference
Reference Type:
publication
Title:
Phthalic anhydride-induced occupational asthma
Author:
Wernfors M, Nielsen J, Schuetz A, Skerfving S
Year:
1986
Bibliographic source:
Int. Arch. Allergy Appl. Immun. 79, 77-82.

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
case report
Principles of method if other than guideline:
out of 118 workers exposed to phthalic anhydride 46 male and 2 female subjects were studied. physical examination and spirometry, skin-prick test were performed. 2 asthmatic subjects were submitted to bronchial provocation with PA dust
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic anhydride
EC Number:
201-607-5
EC Name:
Phthalic anhydride
Cas Number:
85-44-9
Molecular formula:
C8H4O3
IUPAC Name:
1,3-dihydro-2-benzofuran-1,3-dione

Method

Type of population:
occupational
Controls:
no data
Route of administration:
inhalation

Results and discussion

Results of examinations:
The average concentration of phthalic anhydride dust at the workplaces was given as 3-13 mg/m3, of which 40-46% was in the inspirable dust fraction. Out of 118 workers exposed occasionally to phthalic anhydride dust for 2 months or more, 28 (24%) suffered from work-related rhinitis, 13 (11%) from chronic productive bronchitis, and 21 (28%) from work-associated asthma. Three out of eleven asthmatics had a phthalic anhydride-positive skin test, and in two subjects the presence of antibodies was demonstrated.

Any other information on results incl. tables

The latency period between start of employment and onset of respiratory symptoms ranged from 1 month to 16 years. in 8 cases (38%) astma started after a couple of month or less

Applicant's summary and conclusion

Executive summary:

Out of 118 workers exposed to phthalic anhydride 46 male and 2 female subjects were studied. physical examination and spirometry, skin-prick test were performed. 2 asthmatic subjects were submitted to bronchial provocation with PA dust.

The average concentration of phthalic anhydride dust at the workplaces was given as 3-13 mg/m³, of which 40-46% was in the inspirable dust fraction. Out of 118 workers exposed occasionally to phthalic anhydride dust for 2 months or more, 28 (24%) suffered from work-related rhinitis, 13 (11%) from chronic productive bronchitis, and 21 (28%) from work-associated asthma. Three out of eleven asthmatics had a phthalic anhydride-positive skin test, and in two subjects the presence of antibodies was demonstrated.

reference: Wernfors, 1986