Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a manner similar to current testing guidelines withadequate docummentation. However, the GLP regulations were not inforce during the time of study conduct.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
no
Remarks:
The study was conducted in 1977 before the existence of the GLPs.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. -1.4. for Bisphenol A.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Rats of the Wistar strain that had been bred and reared in specific pathogen—free conditions in Shell Toxicology Laboratory (Tunstall) were used. They were 11 weeks old at the beginning of the study. No other details available.

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
clean air
Details on inhalation exposure:
The dust atmosphere of Bisphenol A was generated by means of an Aeroset Powder Spray MK V (Aerostyle Ltd., London). The discharge nozzle of the spray was modified so that it discharged downwards along the central axis of a 0.5 m3 exposure chamber from a point 0.7 m above the chamber floor. The air flow through the chamber was 00l6 m3/ min.
Analytical verification of test atmosphere concentrations:
no
Remarks:
Nominal only based on gravimetrically made determinations.
Duration of exposure:
4 h
Concentrations:
111 mg/m3
No. of animals per sex per dose:
4
Control animals:
no
Details on study design:
Four male and four female rats were exposed continuously to the Bisphenol A dust for four hours. The rats were restrained in cylindrical holders constructed from half—inch wire mesh which prevented them from grooming. After exposure each animal was washed in clean water, dried and then observed for seven days. The rats were then sacrficed and standard autopsy examinations were carried out. All lung lobes of each rat were removed and fixed in 10% neutral buffered formalin solution for subsequent histological examination.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: Histological evidence of respiratory tract irritation.
Effect level:
111 mg/m³ air (nominal)
Based on:
act. ingr.
Exp. duration:
7 d
Remarks on result:
other: There were no mortalities.
Mortality:
None
Clinical signs:
other: Immediately after the exposure all of the rats exhibited alivation. Three of the females and two of the males showed fast respiration and slight to moderate body tremors.
Body weight:
no data
Gross pathology:
There were no macroscopic changes at autopsy which were considered to be related to the treatment.
Other findings:
Histological examination of the lungs revealed mild focal pen— bronchial lymphoid aggregates and perivascular eosinophil infiltration in all cases. Eosinophil infiltration was also occasionally observed in peribronchiolar and subpleural sites. Changes were frequently observed in the bronchiolar epithelium; in particular, hyperplasia, as shown by the presence of a multilayered epithelium without inflammatory cell infiltrate, occurred in seven animals. Occasional eosinophilic droplets were seen in the bronchiolar epithelium of six rats. A small focus of bronchiolitis was observed in one male rat.

Applicant's summary and conclusion

Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
The histological findings in the bronchiolar epithelium of rats exposed to air milled disodium bisphenol—A were considered to be indicative of a mild irritation. No other signs of intoxication were observed in the exposed animals. These data for the structural analog Bisphenol A, suggest that 2-Acetone polymer with phenol (BPA-Tars) may be a respiratory tract irritant
Executive summary:

Air milled disodium bisphenol—A was assesssed for acute dust inhalation toxicity in male and female Wistar rats by four hours of whole body exposure. The histological findings in the bronchiolar epithelium of rats exposed to disodium bisphenol A were considered to be indicative of a mild irritation. No other signs of intoxication were observed in the exposed animals. These data for the structural analog Bisphenol A, suggest that 2-Acetone polymer with phenol (BPA-Tars) may be a respiratory tract irritant