Registration Dossier

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 octaborate
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:
No clinical changes were observed
Body weight:
No data
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.