Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-217-4 | CAS number: 516-03-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25/07/2018
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- A temperature higher than 25°C was registered. The max. value measured was 26°C. A temperature lower than 19°C was registered. The min. value measured was 17°C. This deviation is considered as without impact on the conclusion of the study.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
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: Beranrdy 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: paraffin oil was added just before 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: 8 weeks old
- Weight at study initiation: mean = 215.7 (standard deviation = 16.3)
- Housing: The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free weed shavings which were 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: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): target ranges of 19°C to 25°C
- Humidity (%): target ranges of 30% to 70%
- Air changes (per hr): at least ten changes cycles per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (07.00 to 19.00) and twelve hours darkness
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: fur was removed from the dorsal area of the trunk of the test animal by clipping
- % coverage: At least 10 per cent of the body surface area was clear for the application of the test item.
REMOVAL OF TEST SUBSTANCE
- Washing: The treated area was rinse with paraffin oil.
- Time after start of exposure: After 24-hour exposure period, the gauze dressings were removed and the treated area was rinse with paraffin oil.
TEST MATERIAL
- Amount applied: In view to obtain a solution at 2000 mg/kg, 2.0015 g of the test item were weighed and paraffin oil was added to ta 10 mL volumetric flask.
- Constant volume or concentration used: yes
VEHICLE
The test item was used as supplied in the study. Paraffin oil was chosen as it produced the most suitable formulation at the requested concentration. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight administered under a volume of 10 mL/kg body weight
- No. of animals per sex per dose:
- Range-finding study: 1 female rat Rf2464 treated at 2000 mg/kg.
Main study : 2 female rats Rf2465 & Rf2466 treated at 2000 mg/kg - Control animals:
- not required
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 systemic clinical sign related to the administration of the test item was observed.
- Body weight:
- The body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
Any other information on results incl. tables
Clinical observations
Rf2464 |
TO + 30min |
T0 + 3hours |
T0 + 5hours |
D1 |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Treatment site |
|
|
|
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Rf2465 Rf2466 |
TO + 30min |
T0 + 3hours |
T0 + 5hours |
D1 |
D2 |
D3 |
D4 |
D5 |
D6 |
D7 |
D8 |
D9 |
D10 |
D11 |
D12 |
D13 |
D14 |
Spontaneous activity |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Preyer’s reflex (noise) |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Respiratory rate |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Convulsion |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Tremors |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Body temperature |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Muscle tone |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Palpebral opening |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Pupil appearance |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Salivation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Lachrymation |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Righting reflex |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
Treatment site |
|
|
|
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Remarks |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
None |
Body weight and weight gain in grams
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
Rf 2464 |
198 |
204 |
6 |
242 |
44 |
258 |
60 |
Rf 2465 |
230 |
231 |
1 |
269 |
39 |
284 |
54 |
Rf 2466 |
219 |
226 |
7 |
266 |
47 |
289 |
70 |
MEAN Standard deviation |
215.7 16.3 |
220.3 14.4 |
4.7 3.2 |
259.0 14.8 |
43.3 4.0 |
277.0 16.6 |
61.3 8.1 |
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 dermal 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 applied, as supplied, onto the intact skin of 3 female Sprague Dawley rats at the single dose of 2000 mg/ kg body weight. The experimental protocol was established on the basis of the method as defined in the O.E.C.D. Test Guideline No. 402 dated October 9th, 2017.
No mortality occurred during the study. No systemic clinical sign related to the administration of the test item was observed. The body weight evolution of the animals remained normal throughout 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 dermal 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
