Registration Dossier
Registration Dossier
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EC number: 208-217-4 | CAS number: 516-03-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17/07/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- A temperature higher than 25°C was registered on 17 and 18 April 2018. The maximum value measured was 26°C. This deviation is considered as without impact on the conclusion of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Magnesium oxalate
- EC Number:
- 208-932-1
- EC Name:
- Magnesium oxalate
- Cas Number:
- 547-66-0
- Molecular formula:
- C2H2O4.Mg
- IUPAC Name:
- magnesium oxalate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch No.of test material: Bernardy SAS, Batch No 1601762
- Production date of the batch : 29 September 2016
- Expiration date of the batch: 29 September 2019
- Purity test date: 30/09/2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in opaque plastic flask
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No (Olive oil was added for the oral administration)
FORM AS APPLIED IN THE TEST
White solid powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: supplied by Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: At the beginning of the study, the animals were 8 or 9 weeks old.
- Weight at study initiation: Mean = 199.3grams (standard deviation 11.2 grams)
- Fasting period before study: Food was removed on day 1 and then redistributed 4 hours after the test item administration.
- 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.
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: acclimatization period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ranges of 19°C to 25°C
- Humidity (%): ranges of 30% to 70%,
- Air changes (per hr): at least ten changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: In the first and second steps of the study, 0.3041 g and 0.3005 g of the test item were weighed and olive oil was added to two 10mL volumetric flasks. In the third and fourth steps of the study, 2.0066 g and 2.0004 g of the test item were weighed and olive oil was added to two 10 mL volumetric flasks.
- Amount of vehicle: olive oil was added and each preparation was administered under a volume of 10 mL/kg body weight
- Justification for choice of vehicle: Olive oil was chosen as it produced the most suitable formulation at the requested concentration.
MAXIMUM DOSE VOLUME APPLIED:
The first tested dose was 300 mg/kg body weight. The second dose was 2000 mg/kg body weight.
DOSAGE PREPARATION:
Olive oil was added and each preparation was administered under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula. Just before the administration, the preparations were stirred by vortex to obtain yellow thin homogeneous solutions.
CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was determined according to the toxicological information publicly available on analogue substances. - Doses:
- Two doses were tested : 300 mg/kg body weight and 2000 mg/kg body weight.
- No. of animals per sex per dose:
- 3 female per step (2 steps per dose)
- Control animals:
- yes
- Remarks:
- Three animals, received the control item olive oil. Nothing to report. Animal normal (3/3)
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day D0 (just before administering the test item) then on day 2, day 7, and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examinations of organs in the necropsy.
Results and discussion
- Preliminary study:
- No preliminary study. The starting dose was determined according to the toxicological information publicly available on analogue substances.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No effect observed.
- Clinical signs:
- No effect observed.
- Body weight:
- No effect observed.
- Gross pathology:
- No effect observed.
Any other information on results incl. tables
Application: 300 mg/kg body weight (oral route)
Table 1
Observations |
Females |
Females |
||||
T0 + 30 minutes T0 + 1 hour T0 + 3 hours T0 + 4hours |
Rf 2467 |
Rf 2468 |
Rf 2469 |
Rf 2470 |
Rf 2471 |
Rf 2472 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
||||
Table 2
Observations |
Females |
Females |
||||
T0 + 30 minutes T0 + 1 hour T0 + 3 hours T0 + 4hours |
Rf 2467 |
Rf 2468 |
Rf 2469 |
Rf 2470 |
Rf 2471 |
Rf 2472 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
||||
Application: 2000 mg/kg body weight (oral route)
Table 3
Observations |
Females |
Females |
||||
T0 + 30 minutes T0 + 1 hour T0 + 3 hours T0 + 4hours |
Rf 2476 |
Rf 2477 |
Rf 2478 |
Rf 2487 |
Rf 2488 |
Rf 2489 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
||||
Table 4
Observations |
Females |
Females |
||||
T0 + 30 minutes T0 + 1 hour T0 + 3 hours T0 + 4hours |
Rf 2476 |
Rf 2477 |
Rf 2478 |
Rf 2487 |
Rf 2488 |
Rf 2489 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
Back hair appearance |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
||||
Body weight and weight gain in grams
Table 5
Females |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 2467 |
189 |
208 |
19 |
226 |
37 |
245 |
56 |
Rf 2468 |
206 |
224 |
18 |
234 |
28 |
265 |
59 |
Rf 2469 |
185 |
209 |
24 |
231 |
46 |
265 |
80 |
Rf 2470 |
196 |
220 |
24 |
229 |
33 |
259 |
63 |
Rf 2471 |
214 |
231 |
17 |
252 |
38 |
274 |
60 |
Rf 2472 |
206 |
209 |
3 |
240 |
34 |
281 |
75 |
MEAN |
199.3 |
216.8 |
17.5 |
235.3 |
36.0 |
264.8 |
65.5 |
Standard deviation |
11.2 |
9.6 |
7.7 |
9.5 |
6.0 |
12.4 |
9.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Magnesium oxalate 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 Magnesium oxalate 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. - Executive summary:
The test item Magnesium oxalate was administered to a group of 6 female Sprague Dawley rats at the dose of 300 mg/kg body weight and then to a group of 6 female Sprague Dawley rats at the dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the O.E.C.D. Test Guideline No. 423 dated December 17th, 2001 and the test method B.1tris of the Council regulation No. 440/2008.
No mortality was noted in the animals treated at the dose of 300 mg/kg body weight. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
No mortality was noted in the animals treated at the dose of 2000 mg/kg body weight. No clinical signs related to the administration of the test item were observed during the study. The body weight evolution of the animals remained normal during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
In conclusion, the LD50 of the test item Magnesium oxalate 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 Magnesium oxalate 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.
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