Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
other: GLP, guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
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:
magnesium diacrylate
EC Number:
227-177-9
Cas Number:
5698-98-6
Molecular formula:
C3H4O2.1/2Mg
IUPAC Name:
magnesium diacrylate
Test material form:
other: liquid
Details on test material:
aqueous solution of magnesium acrylate, 46.41 %
density: 1.248 g/ml
purity (based on 100% magnesium acrylate): 99.7%
pH-value: 6.4
colour: brown,
storage: at room temperature in darkness
expiry date: 18. November 2012

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier, F-53940 Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 190 - 203 g
- Fasting period before study: no
- Housing: by groups of three
- Diet: ad libitum
- Water: ad libitum
- Acclimatization: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30-70
- Air changes (per hr): 10 - 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 46.41% magnesium acrylate solution in water (test item) was applied as supplied by the sponsor without any use of further vehicle.
- Amount of vehicle (if gavage): 3.526 ml/kg body weight corresponding to 4400 mg/kg body weight of pure test item based on the density of 1.248 g/ml
Doses:
2042 mg Magnesium acrylate/kg body weight corresponding to 4400 mg/kg b.w. of the test item as supplied by the sponsor (46.41% solution with a density of 1.248 g/ml)
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily (clinical signs)
- Frequency of weighing: D0, 2, 7 and day 14
- Necropsy of survivors performed: yes
The study was performed in two steps. In the first and the second step of the study, the test item was administered by stomach tube under a volume of 3.526 ml/kg body weight (corresponding to 4400 mg/kg b.w. of the test item as supplied by the sponsor (Density 1.248 g/ml)) using a suitable graduated syringe fitted with an metal canula.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 042 mg/kg bw
Based on:
act. ingr.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 400 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 46.61 % magnesium acrylate aqueous solution
Mortality:
no mortality occcured during the study
Clinical signs:
no clinical signs ofserved
Body weight:
both groups showed a similar increase in bodyweight
Gross pathology:
no abnormal findings

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The LD 50 of Magnesium acrylate in a 46.41% test item solution is higher than 2000 mg Magnesium acrylate/kg body weight after oral administration by gavage in the rat.
Executive summary:

A magnesium acrylate solution in water, 46.41 %, was administered to 2 groups of 3 female Sprague-Dawley rats by stomach tube. After repeated administration of 2042 mg/kg b.w. in 3.526 ml/kg b.w. no clinical signs and no mortality were observed.

After administration the body weight gain in both groups was still positive. The dissection of the animals at the end of the study revealed no macroscopic changes.

According to the results of this study the LD50 of Magnesium acrylate is higher than 2000 mg/kg b.w. and higher than 4400 mg/kg b.w. for Magnesium acrylate aqueous solution (46.41% solid content).

According to the criteria for classification, packing and labelling of dangerous substances and preparations in accordance with the EEC Directives 67/548, 2001/59 and 1999/45, the test item Magnesium acrylate solution must not be classified.

No symbol or risk phrase is required.

In accordance with the Regulation EC No. 1272/2008 on classification , labelling and packing of substances and mixtures, the test item must not be classified. No signal word or hazard statement is required.