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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Remarks:
This study was carried out to confirm a previous study, that indicated the LD50 was > 2000 mg/kg, where 40 % of the male rats died at 2000 mg/kg. Doses were selected on the basis of clinical observations and time of onset of signs or death previously.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium tetraborate, anhydrous
EC Number:
215-540-4
EC Name:
Disodium tetraborate, anhydrous
Cas Number:
1330-43-4
Molecular formula:
Na2B4O7
IUPAC Name:
Disodium tetraborate
Details on test material:
- Name of test material: Dehybor® anhydrous Borax
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 5C152748
- Stability: Stable

Test animals

Species:
rat
Strain:
other: Crl:CD.BR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River UK.
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 143-198 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle: Adjusted to weight of animal

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
1600; 2500 mg/kg bw
No. of animals per sex per dose:
Five males per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Mortality:
None
Clinical signs:
other: No deaths occurred. No effects at 1600 mg/kg. At 2500 mg/kg, piloerection observed in one animal that recovered by day 2. No other adverse effects were observed.
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The LD50 for male rats administered the test substance by oral gavage was > 2500 mg/kg bw.