Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Experimental data reported in peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Occupational exposure to hexahydrophthalic anhydride: air analysis, percutaneous absorption, and biological monitoring
Author:
Jonsson B A G, Welinder H, Hansson C and Stahlbom B
Bibliographic source:
Int Arch Occup Environ Health 65(1): 43-47, 1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Percutaneous absorption of HHPA was studied by application of the substance in petrolatum to the back skin of three volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Test material form:
liquid

Test animals

Species:
human
Strain:
other: n/a
Sex:
male
Details on test animals and environmental conditions:
TEST SUBJECTS
- Age at study initiation: 22, 32 and 51 years
- Weight at study initiation: 70, 90 and 90 kg
:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
petrolatum
Duration of exposure:
48 hours
Doses:
- Nominal doses: 1.4 mg HHPA in 2% petrolatum

Results and discussion

Any other information on results incl. tables

Measurable levels of HHP acid, the hydrolysis product of HHPA, were only found in the urine of two of the three subjects, and these levels were only slightly above the limit of detection of the analytical method. In one subject, this was in urine collected 8 - 24 hours after application of HHPA and in the second subject measurable levels were found in urine collected 8 - 12 hours after application of HHPA.

The excreted amounts of HHP acid, as a fraction of the totally applied amount of HHPA, were within the range of 1.4 - 4.5% in one subject, 0.2 - 1.3% in the second subject and 0 0.4% in the third subject.

Applicant's summary and conclusion

Conclusions:
The excreted amounts of HHP acid, as a fraction of the totally applied amount of HHPA, were within the range of 1.4 - 4.5% in one subject, 0.2 - 1.3% in the second subject and 0 0.4% in the third subject suggesting that percutaneous absorption of HHPA is low.
Executive summary:

Percutaneous absorption has been studied in human volunteers. The excreted amounts of HHP acid, as a fraction of the totally applied amount of HHPA, were within the range of 1.4 - 4.5% in one subject, 0.2 - 1.3% in the second subject and 0 0.4% in the third subject suggesting that percutaneous absorption of HHPA is low.