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Toxicological information

Repeated dose toxicity: oral

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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:
1995
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:
1987
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Unpublished report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
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals 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

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)