Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-832-3 | CAS number: 97416-84-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. The justification for the Read Across approach has been attached to the Section 13 The summary report is taken from IPCS Environmental Health Criteria 172 (WHO), which is a relayble internationally accepted sorce.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Tetrabromobisphenol A and Derivatived (Environmental health criteria ; 172).
- Author:
- G.J. van Esch
- Year:
- 1 995
- Bibliographic source:
- World Health Organization; IPCS
- Reference Type:
- secondary source
- Title:
- PE-68, Bis (2,3-dibromopropyl ether) of tetrabromobisphenol A
- Author:
- Great Lakes ChemicalCorporation
- Year:
- 1 987
- Bibliographic source:
- Unpublished report
Materials and methods
- Principles of method if other than guideline:
- No information available on the method used
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No information available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- No information available
- Details on analytical verification of doses or concentrations:
- No information available
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Once a day
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
200 mg/kg bw per day
Basis:
other: in diet
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw per day
Basis:
other: in diet
- No. of animals per sex per dose:
- No information available
- Control animals:
- not specified
- Details on study design:
- No information available
- Positive control:
- No information available
Examinations
- Observations and examinations performed and frequency:
- No information available
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- At the end of the study, no deaths had occured at either level. No abnormal symptoms were observed in the gross pathological examination.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- > 2 000 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- not specified
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL(90days) > 2000 mg/kg bw/day
- Executive summary:
References
The evaluation of Repeated dose toxicity by oral route (90 days) reported from Great Lakes Chemical Corporation (1987)[1] in the WHO publication[2] has been considered in order to complete the assessment.
Method and observations
Mice were administered levels of 200 or 2000 mg/kg per day in their diet for 90 days. At the end of the study, no deaths had occurred at either level. No abnormal symptoms were observed in the gross pathological examination. No further information on the method used is available.
Results
The NOAEL reported on the Similar Substance 01 in these reviews is greater than 2000 mg/kg bw/day.
[1] Great Lakes Chemical Corporation (1987) Summaries of toxicity data. PE-68, Bis(2,3-dibromopropyl ether) of tetrabromobisphenol A. West Lafayette, Indiana, Great Lakes Chemical Corporation (Unpublished report submitted to WHO by the Brominated Flame Retardant Industry Panel).
[2]World Health Organization (WHO, Geneva, 1995); Dr. G.J. van Esch “Tetrabromobisphenol A and Derivatived” (Environmental health criteria; 172)
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
