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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
other: See below.
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.

Data source

Reference
Reference Type:
publication
Title:
Tetrabromophthalic anhydride [CASRN 632-79-1] Review of the toxicological literature,
Author:
Tice
Year:
1999
Bibliographic source:
Tetrabromophthalic anhydride [CASRN 632-79-1] Review of the toxicological literature,

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test article applied dermally, 5 d/wk, for 4 wk.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
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
Details on test material:
Data reported is for the analog tetrabromophthalic anhydride.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
4 wks
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 50, 500, 5000 mg/kg
Basis:
nominal per unit body weight

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: see below

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

see below

Applicant's summary and conclusion

Conclusions:
The analog's 4 wk NAOEL dermal in rabbits was 500 mg/kg/d administered once daily 5 d/wk.
Executive summary:

Tetrabromophthalic anhydride applied dermally to the dorsal skin of New Zealand White rabbits at dose levels of 50, 500, and 5000 mg/kg (0.11, 1.08, 10.78 mmol/kg) daily for 5 days per week for 4 weeks resulted in very slight to moderate erythema (Wazeter and Goldenthal, 1975d). At 5000 mg/kg/day, 3 rabbits showed moderate erythema desquamation, while 1 rabbit showed marked ataxia, the inability to lift its head or right itself, and dyspnea. The deaths or condition requiring sacrifice of the high-dose animals were considered compound-related. At the lower doses, statistically significant increases in bromine concentration in skin were found.

See Section 7.12.