Registration Dossier

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:
1963
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

Constituent 1
Reference substance name:
1303-96-4
EC Number:
603-411-9
Cas Number:
1303-96-4
IUPAC Name:
1303-96-4
Constituent 2
Reference substance name:
Disodium tetraborate decahydrate
IUPAC Name:
Disodium tetraborate decahydrate
Details on test material:
- Name of test material: Disodium tetraborate decahydrate

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.