Registration Dossier
Registration Dossier
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EC number: 700-066-7 | CAS number: 1472633-72-9
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:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 963
- Report date:
- 1963
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not specified
- Principles of method if other than guideline:
- Male and female Sprague-Dawley rats were exposed daily to the test substance in the diet, which was available ad libitum. A concurrent no treatment control group was included.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Limit test:
- no
Test material
- Reference substance name:
- 1303-96-4
- EC Number:
- 603-411-9
- Cas Number:
- 1303-96-4
- IUPAC Name:
- 1303-96-4
- Reference substance name:
- Disodium tetraborate decahydrate
- IUPAC Name:
- Disodium tetraborate decahydrate
- Details on test material:
- - Name of test material: Disodium tetraborate decahydrate
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 Days
- Frequency of treatment:
- Daily; food ad lib
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 7.8, 23, 78 and 230 mg/kg bw/d, equivalent to 0, 17.5, 52.5, 175 and 525 ppm boron; equivalent boron 0, 0.88, 2.6, 8.8, and 26 mg B/kg bw/d.
Basis:
actual ingested
- No. of animals per sex per dose:
- 10/sex/group
- Control animals:
- yes, concurrent no treatment
Results and discussion
Results of examinations
- Details on results:
- No adverse effect were observed at any dose tested.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 230 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects were observed at any dose tested.
- Dose descriptor:
- NOAEL
- Effect level:
- 26 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were observed at any dose tested.
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.
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