Reaction products of tetrabromophthalic anhydride with 2,2'-oxydiethanol and methyloxirane

Repeated dose toxicity: inhalation

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

Test material information

Constituent 1

Reference substance name:

Tetrabromophthalic anhydride

EC Number:

211-185-4

EC Name:

Tetrabromophthalic anhydride

Cas Number:

632-79-1

Molecular formula:

C8Br4O3

IUPAC Name:

4,5,6,7-tetrabromo-2-benzofuran-1,3-dione

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.