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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
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:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: This study was carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP.
Deviations:
not specified
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: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: USB-12-84
- Stability: Stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: LaCrosse Industries Inc., Schenectady , New York.
- Weight at study initiation: Males: 2.19 +/- 0.27kg; females: 2.29 +/- 0.28kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: Area not specified. The back of each rabbit was clipped free of fur prior to treatment.
- Type of wrap if used: Not specified


REMOVAL OF TEST SUBSTANCE
- Washing: Moist towel
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount applied: Dosage to 2 g/kg bw
Duration of exposure:
24 h
Doses:
Dosage to 2 g/kg bw
No. of animals per sex per dose:
Five/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: Clinical signs, pathlogy
Statistics:
Not relevant – Limit test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
Clinical changes included anorexia and decreased activity in four rabbits, diarrhoea and soft stools in 3 rabbits and nasal discharge in three rabbits.
Body weight:
No data
Gross pathology:
The only finding in one rabbit was abdominal cavity filled with fluid.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Acute dermal limit study carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP. The LD50 was > 2000 mg/kg bw indicating no acute dermal toxicity.