Phthalic acid

Respiratory sensitisation

Administrative data

Endpoint:

respiratory sensitisation, other

Remarks:

respiratory allergenicity test in guinea pigs

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No OECD guideline or GLP defined. No purity of test substance defined.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Materials and methods

Principles of method if other than guideline:

respiratory allergenicity test in guinea pigs: Briefly, guinea pigs were individually housed in whole body plethysmogryphs connected to a Model DP103 ultralow range differential pressure transducer. respiratory rate and peak height (change in pressure) from each animal were continuously monitored on a ZF-8000 chart recorder interfaced with an IBM PC/AT computer. One group of five guinea pigs and one group of six guinea pigs were exposed for 3 hr/day for 5 consecutive days to Phthalic Acid (PA) dust ranging between 0.05 to 0.2 mg/m³ and 0.6 to 6 mg/m³ respectively. PA concentrations were chosen to bracket the published threshold limit value (TLV) for PA (6.0 mg/m³; ACGIH, 1990). Two weeks after the last chemical exposure, air control (eight animals) and chemical exposed animals were challenged for 30 min with aerosolized chemical-GPSA conjugate (95% respirable). Respiratory baseline measurements were made for 30 min preexposure to challenge antigen. Significant respiratory reactions to challenge antigen were defined as increases in breath peak height and/or respiratory rate that were greater than 3 standard deviations from the mean change in the same parameters of control animals exposed to chemical-protein conjugate. These responses must be sustained for at least 5 min in order to be scored as positive.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Phthalic acid

EC Number:

201-873-2

EC Name:

Phthalic acid

Cas Number:

88-99-3

Molecular formula:

C8H6O4

IUPAC Name:

benzene-1,2-dicarboxylic acid

Details on test material:

phthalic acid (Fisher Scientific, Fair Lawn, NJ), No purity defined.

Test animals

Species:

guinea pig

Strain:

Hartley

Sex:

female

Test system

Route of induction exposure:

inhalation

Route of challenge exposure:

inhalation

Vehicle:

not specified

Concentration:

no data

No. of animals per dose:

10

Results and discussion

Any other information on results incl. tables

Specific Serum Antibody Titers and percentage of animals with respiratory Reactivity to Chemical-GPSA Conjugate: Injection with Equimolar Doses of Chemical:

Phthalic Acid	Respiratory reactivity (Consecutive contractions every 36 -40 normal breaths after IT challange with conjugate)	Mean ELIZA titer (+SE) (Titers were defined as the reciprocal of the highest dilution of sera yielding positive responses in ELISA or PCA test.	Mean PCA titer (+SE)
6.7x10^-4M	0% (0/10)	0	0

Applicant's summary and conclusion

Executive summary:

In an respiratory allergenicity test in female hartley guinea pigs the test substance prooved to be non-sensitizing.