Registration Dossier

Administrative data

Endpoint:
sub-chronic 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: see 'Remark'
Remarks:
Read across, rather than actual data, was used for this endpoint. The studies cited in Section 7.12 were previously screened in the OECD SIDS or U.S. National Institute of Health program,s and/or performed by the U.S. National Cancer Institute or U.S. National Toxicology Program or available in the open literature.
Justification for data waiving:
other:

Data source

Reference
Reference Type:
publication
Title:
Tetrabromophthalic anhydride [CASRN 632-79-1] Review of the toxicological literature,
Author:
Tice
Year:
1999
Bibliographic source:
http://ntp.niehs.nih.gov/ntp/htdocs/Chem_Background/ExSumPdf/Tetrabromophthalic.pdf, pp. 1-15 (See Appendix 6.2).

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Dust exposures of 2 or 8 mg/L for 4 hr daily, 5 d/wk, for 3 wks
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Spartan
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 hr daily
Frequency of treatment:
5 day/wk for 3 wks
Doses / concentrations
Remarks:
Doses / Concentrations:
2, 8 mg/L
Basis:
nominal conc.
Control animals:
yes, concurrent no treatment

Results and discussion

Effect levels

Dose descriptor:
NOEC
Remarks:
mortality, systemic toxicity
Effect level:
8 mg/L air
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: see below

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In Spartan albino rats exposed to a dust atmosphere of tetrabromophthalic anhydride (2 or 8 mg/L; 104 or 422 ppm) for 4 hours daily 5 days a week for 3 weeks in a sealed glass chamber, salivation, lacrimation, nasal discharge, and nasal porphyrin discharge were reported (Wazeter and Goldenthal, 1975e). At 20 days hematological, biochemical, and urinalysis studies showed no changes related to the chemical. Decreases in liver weights and increases in lung weights, however, were considered compound-related. The higher incidence of inflammatory lung lesions in both exposure groups compared to that in the control group may have also been compound-related. Necropsy showed no gross pathological lesions
Executive summary:

In Spartan albino rats exposed to a dust atmosphere of tetrabromophthalic anhydride (2 or 8 mg/L; 104 or 422 ppm) for 4 hours daily 5 days a week for 3 weeks in a sealed glass chamber, salivation, lacrimation, nasal discharge, and nasal porphyrin discharge were reported (Wazeter and Goldenthal, 1975e). At 20 days hematological, biochemical, and urinalysis studies showed no changes related to the chemical. Decreases in liver weights and increases in lung weights, however, were considered compound-related. The higher incidence of inflammatory lung lesions in both exposure groups compared to that in the control group may have also been compound-related. Necropsy showed no gross pathological lesions.