Registration Dossier
Registration Dossier
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EC number: 201-236-9 | CAS number: 79-94-7
Repeated dose toxicity: inhalation
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:
- 1 975
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
Constituent 1
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.
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