Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is old. The lack of toxicity is consistent with the acute and repeated dose toxicity of TBBPA.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Reference Type:
publication
Title:
Unnamed
Year:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
not specified
Vehicle:
air
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 h daily, 5 d/wk for 2 weeks
Frequency of treatment:
see above
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2,6,18 mg/L
Basis:
nominal conc.
No. of animals per sex per dose:
5m/5f/dose
Control animals:
yes, concurrent no treatment

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
excessive salivation, red or clear nasal discharge
Mortality:
mortality observed, treatment-related
Description (incidence):
excessive salivation, red or clear nasal discharge
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
effects observed, treatment-related
Description (incidence and severity):
excessive tearing
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not examined

Effect levels

open allclose all
Dose descriptor:
NOAEC
Effect level:
>= 18 mg/L air (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: lack of effects
Dose descriptor:
NOAEC
Effect level:
>= 18 000 mg/m³ air (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: lack of effects

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Excessive salivation, red or clesar nasal discharge, and excessive lacrimation were noted during the course of the study in rats at the two highest dose levels. These effects are likely related to physical effects of the extremely high doses.

No deaths, and no changes in body weight gain, food consumtpin, haematoligcal and biochemical parameters, and urinalysis were noted. A decrease in relative liver weight of females might have been compound related. No gross or microscopic lesions were observed in any of the treated rats.

Applicant's summary and conclusion

Conclusions:
14 d NOAEC of micronizied TBBPA in this 14 d study was 18 mg/L air, equivalent to 18000 mg/m3.
Executive summary:

Inhalation of micronized TBBPA at doses up to 18 mg/L air (ca. 18000 mg/m3) for 4 h daily, 5 d/wk for two weeks did not result in adverse effects in rats.