Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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
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

Constituent 1
Chemical structure
Reference substance name:
Reference substance 001
EC Number:
601-808-1
Cas Number:
12179-04-3
Molecular formula:
Na2B4O7.5H2O
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 or test system 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:
other: Clinical changes included anorexia and decreased activity in four rabbits, diarrhoea and soft stools in 3 rabbits and nasal discharge in three rabbits.
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:
other: EU GHS criteria not met
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.