Registration Dossier

Administrative data

Endpoint:
respiratory sensitisation: in vivo
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

Reference
Name:
Unnamed
Type:
Constituent
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.