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Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1993

Materials and methods

Type of study / information:
Type of experience: Human
Endpoint addressed:
respiratory sensitisation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No information on guideline. For details on method please refer to IUCLID5 dossier.
GLP compliance:
no

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): HHPA

Method

Ethical approval:
not specified
Details on study design:
no details given
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: inhalation at the factory
TYPE OF EXPOSURE MEASUREMENT: Area air sampling/Biomonitoring (urine) / Biomonitoring blood:
Six healthy volunteers were exposed to gaseous hexahydrophthalic  anhydride (HHPA) concentrations of 
10, 40, or 80 ug/m3 (65, 260, 520  nmole/m3, respectively) for 8 hr.

Results and discussion

Results:
The correlations (r>0.90) between  the air concentrations of HHPA and levels of HHP acid in plasma and urine  were close. They were even closer (r>0.96) when the total respiratory  uptake of HHPA was used. Urinary pH adjustment by intake of ammonium  chloride or sodium hydrogen carbonate did not significantly alter the excretion of HHP acid.

Any other information on results incl. tables

Six healthy volunteers were exposed to gaseous hexahydrophthalic anhydride (HHPA) concentrations of 10, 40, or 80 ug/m3 (65, 260, 520 nmole/m3, respectively) for 8 hr. The respiratory uptake of the inhaled HHPA was almost complete. Rapid increases in plasma and urinary levels of hydrophthalic acid (HHP acid) were seen. During the first 4 hr after the end of exposure, the half-time of HHP acid in plasma was about 2 hr. A corresponding decay was seen in urine. The correlations (r>0.90) between the air concentrations of HHPA and levels of HHP acid in plasma and urine were close. They were even closer (r>0.96) when the total respiratory uptake of HHPA was used. Urinary pH adjustment by intake of ammonium chloride or sodium hydrogen carbonate did not significantly alter the excretion of HHP acid. The results show that the analysis of HHP acid in plasma or urine is useful as a biological monitor for exposure to HHPA.

Applicant's summary and conclusion

Conclusions:
 The results show that the analysis of HHP acid in plasma or urine is useful as a biological monitor for exposure to HHPA.
Executive summary:

Six healthy volunteers were exposed to gaseous hexahydrophthalic anhydride (HHPA) concentrations of 10, 40, or 80 ug/m3 (65, 260, 520 nmole/m3, respectively) for 8 hr. The respiratory uptake of the inhaled HHPA was almost complete. Rapid increases in plasma and urinary levels of hydrophthalic acid (HHP acid) were seen. During the first 4 hr after the end of exposure, the half-time of HHP acid in plasma was about 2 hr. A corresponding decay was seen in urine. The correlations (r>0.90) between the air concentrations of HHPA and levels of HHP acid in plasma and urine were close. They were even closer (r>0.96) when the total respiratory uptake of HHPA was used. Urinary pH adjustment by intake of ammonium chloride or sodium hydrogen carbonate did not significantly alter the excretion of HHP acid. The results show that the analysis of HHP acid in plasma or urine is useful as a biological monitor for exposure to HHPA.