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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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.
Body weight:
No data
Gross pathology:
No data
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: No data
Remarks:
Criteria used for interpretation of results: other: No data
Conclusions:
The LD50 for male rats administered the test substance by oral gavage was > 2500 mg/kg bw.