Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study consisted of an andequate number of animals adminstered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Section 1500.41 - Hazardous Substances and Articles, Administration and Envforcement Regulations, U.S. Federal Register, 38(187), p 27019, 27 Sept 1973.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Principles of method if other than guideline:
5 male and 5 female rats administered a single oral dose by gavage in corn oil of 7.5 g/kg, and observed for 14 d.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
EC Number:
251-118-6
EC Name:
N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
Cas Number:
32588-76-4
Molecular formula:
C18H4Br8N2O4
IUPAC Name:
N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Doses:
Single oral dose of 7.5 g/kg bw
No. of animals per sex per dose:
5 males and 5 female
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 7.5 other: gm/kg bw
Based on:
test mat.
Remarks on result:
other: no rats died on test

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
EBTBP was not acutely toxic to rats by the oral route.
Executive summary:

One group of 5 male and 5 female Sherman-Wistar rats was administered a single dose of EBTBP by gavage in corn oil at 7,500 mg/kg. The animals were observed for 14 days. No animals died on test. The oral LD50 was > 7,500 mg/kg.