Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
A relative humidity higher than 70% was registered on 06 November.2017. The maximum value measured was 82%. This deviation is considered as without impact on the conclusion of the study.
Qualifier:
according to
Guideline:
EU Method B.1 tris (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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Animals:
6 Sprague Dawley rats were used after an acclimatization period of at least five days. The animals were nulliparous and non-pregnant. At the beginning of the study, the animals were 8-week old.

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 relative humidity during the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively. The rate of air exchange was at least ten 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 and foodstuff were supplied ad libitum. Food was removed on day 1 and then redistributed 4 hours after the test item administration.

Examination:
Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 30 min, 1h, 3h, 4h, 24h, 48h after administration of the test item and continued daily during 14 days. 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. Clinical observations and mortality were recorded every day for 14 days.
The animals were weighed on day D0 (just before administering the test item) then on day 2, day 7, and day 14. Weight changes were calculated and recorded. The body weight evolution of animals treated with the test item is compared with the body weight evolution of the historical control group.
On D14, the animals were euthanized with sodium pentobarbital. 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.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
Each preparation was administered under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females rats were administered 2000 mg/kg bw test item
Control animals:
no

Results and discussion

Effect levels
Key result
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 during the study.
Body weight:
The body weight evolution of the animals remained normal during the study.
Gross pathology:
The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the LD50 of the test item Gamma Cobalt is higher than 2000 mg/ kg body weight by oral route in the rat. In accordance with the O.E.C.D. Test 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.
The test item Gamma Cobalt does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.