Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Six Sprague Dawley rats (SPF Caw) originated from Elevage JANVIER (53940 Le Genest St Isle - France), were used after an acclimatization period of
at least five days. At the beginning of the study, the animals of the treated group weighed between 193 g and 204 g and were 8 weeks old.
They were identified prior to inclusion in the test by means of numbered rings on the edges of their ears.

Group treated (2000 mg/kg): 3 female rats Rf6861 to Rf6863 (Step 1)
3 female rats Rf6886 to Rf6888 (Step 2)

Housing:
Healthy female rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry. The temperature and reletive humidity of the main test were controlled to remain within target ranges of 19-25°C amd 30-70 %, respectively.
The rae of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff (M20, SDS) were supplied freely Food was removed at D-l and then
redistributed 4 hours after the test item administration. Microbiological and chemical analyses of the water were carried out once every six
months by IPL, Sante, Environnement Durables - Atlantique (Bordeaux).

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
In the first and second steps of the study, 2 g or 4 g of the test item was weighed and olive oil was added to a 10 or 20 inL volumetric flask, respectively. The preparation was magnetically stirred to obtain a yellow homogeneous suspension, just before the administration. The preparation was administered by gavage under a volume of 10 mL/kg body weight, using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
The animals of the treated group received an effective dose of 2000 mg/kg body weight of the test item.
No. of animals per sex per dose:
3 / 3
Control animals:
no
Details on study design:
Examinations of the animals

Daily examination:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days
following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent"
on the observation sheet. These observations were compared to historical control data. Observations and a mortality report were then carried
out every day for 14 days.

Periodical examinations:
The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14. Weight changes were calculated and
recorded.

Examination at the end of the test:
On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations
were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was
removed and preserved in view to microscopic examinations.

The study was perfomed in accordance with the French Animal Protection Law under licence number C33-122-001.
The animals were provided with suitable environmental enrichment (Tunnel). The study was designed and was conducted to cause the
minimum suffering or distress to the animals.

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 related to the administration of the test item were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment related change.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the EEC Directives 67/548, 2001/59 and 99/45, the test item Diethyl-(3-pyridyl)borane must not be classified. No symbol or risk phrase is required. In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.
Executive summary:

The test item Diethyl-(3-pyridyl)borane was administered to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No. 423 dated December 17th, 2001 and the test method B.ltris of the Council regulation No. 440/2008. No mortality occurred during the study. No clinical signs related to the administration of the test item were observed. The body weight evolution of the animals remained normal throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment related change. In conclusion, the LD50 of the test item Diethyl-(3-pyridyl)borane is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat.