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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-01-12 to 2004-01-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study reliable without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001-12-17
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Boron
EC Number:
231-151-2
EC Name:
Boron
Cas Number:
7440-42-8
Molecular formula:
B
IUPAC Name:
Boron
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Bor kristallin
- Physical state: grey to black, odourless powder
- Storage condition of test material: room temperature, closed original container, dry
- Water solubility: < 1mg/L
- pH: 7 (suspension in water [100 g/L])
- Particle size distribution: D90 = 33.06 µm; D50 = 13.76 µm; D10 = 2.34 µm

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS - SPF rats
- Source: Firma Charles River Wiga GmbH, D-97320 Sulzfeld
- Age at study initiation: ca. 8 weeks
- Weight at study initiation (before application of test substance): mean body weight (n = 6): 195.0 g ± 8.4 g
- Fasting period before study: the night before the application of the test material and 3 hours following the application of the test material
- Housing: during the acclimation period the animals were housed in groups of up to three animals in Makrolon type 3 cages. From the moment of randomisation up to the end of the observation period the animals were housed individually in Makrolon Type 3 cages. ALTROMIN TYP S8/15 (laboratory animal bedding material, soft wood granulates, charge: 071103 and 080104 (from 23.01.2004)) was used as bedding material.
- Diet (ad libitum): ALTROMIN 1324, standard diet, maintenance diet rats/mice (Firma ALTROMIN, D-32791 Lage/Lippe; charge: 220204/1144)
- Water (ad libitum): tap water, drinking water quality, changed daily
- Acclimation period: 7 and 8 days, respectively

ENVIRONMENTAL CONDITIONS
- Temperature: 20.5 - 21.5 °C
- Relative humidity: 30 - 45%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.5% Tylose solution in demineralised water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1/100 g bw

DOSAGE PREPARATION:
The test material was suspended in a 0.5% tylose solution in demineralised water. During the application procedure the suspension was stirred to ensure a homogenous distribution.
(3 g test material with 15 mL 0.5% tylose solution in demineralised water)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for mortality/morbidity continuously on the day of test item application and at least once daily thereafter (morning). The animals were observed for clinical signs continuously on the day of test item application and once daily thereafter (morning). The body weight of the animals was determined on the day before the application of the test material and on the day of application as well as on day 7 and 14 after application.
- Necropsy of survivors performed: yes; at the end of the observation period all animals were killed and macroscopically examined (body surface, skull, chest cavity and abdominal cavity and including the respective organs)
Statistics:
Body weight and body weight increase: calculation of mean body weight and standard deviation and comparison with historical control data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
The development of the body mass of the animas was not influenced (comparison with historical control data).
Gross pathology:
No macroscopical findings were made.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rat) > 2000 mg/kg bw (LD50 cut-off value: 5000 mg/kg bw)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

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