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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA (40 CFR 158, 162); TSCA (40 CFR 798)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium octaborate
EC Number:
234-541-0
EC Name:
Disodium octaborate
Cas Number:
12008-41-2
Molecular formula:
Na2B8O13
IUPAC Name:
disodium bis[(oxoboranyl)oxy]bicyclo[5.5.1]hexaboroxane-3,5-bis(olate)
Details on test material:
- Name of test material: Disodium octoborate tetrahydrate
- Physical state: White powder
- Analytical purity: > 98 %
- Lot/batch No.: 8G1D
- Stability under test conditions: 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: Clerco Research Farm
- Weight at study initiation: Males: 2720 -3379 g; females: 2699 –3057 g

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
physiological saline
Details on dermal exposure:
TEST SITE
- Area of exposure: No data
- % coverage: Not specified but implies > 10 % of body surface
- Type of wrap if used: Semi occlusive


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


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: No data
- Other examinations performed: Clinical signs and histopathology
Statistics:
No data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No lethal effect at limit dose
Clinical signs:
other: No clinical changes were observed
Gross pathology:
No gross necropsy findings were observed.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: EU GHS criteria not met
Conclusions:
The acute dermal LD50 was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.
Executive summary:

The test item disodium octaborate tetrahydrate was assessed for dermal acute toxicity in rabbits in a GLP study according to OECD Guideline 402. Five animals per sex per dose were exposed via gavage to a single dose of the test item of 2.0 g/kg bw. The acute dermal LD50 for males and females was > 2000 mg/kg bw indicating no acute dermal toxicity. No clinical or pathological findings were observed.