Magnesium acrylate

Endpoint summary

Description of key information

The main and most relevant toxic effects of the reference substance acrylic acid are the corrosive properties. Magnesium acrylate is the magnesium salt of the organic acid acrylic acid. As the study on irritation and corrosion showed, Magesium acrylate has practically no corrosive and only weak irritative properties not leading to classification and labelling.  Additionally the metabolism studies showed, that ingested acrylic acid is rapidly and completly metabolised. This should be true also for Magnesium acrylate.  As a consequence Magesium acrylate has only a weak toxicity.
Acute toxicity via oral route: LD50 > 2000 mg/kg bw
Acute toxicity via dermal route: LD50 > 2000 mg/kg bw
Inhalation: no study available
Magnesium acrlyate is a salt, the melting point of the solid is higher than 300°C. Exposure of humans via inhalation by aerosols, particles or droplets of an inhalable size is not possible during manufacturing or application of the aqueous magnesium acrylate solution  (concentration <50%). See Annex VIII column 2 under point 8.5.2 of the REACH regulation.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

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

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

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.

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:

other: no clinical signs ofserved

Gross pathology:

no abnormal findings

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Quality of whole database:

LD50 > 2000 mg/kg bw, reliable without restriction.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011-06-09 - 2011-07-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guidline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 221.6 +- 3.8 (male), 185.5 +- 5.9 g (female)
- Fasting period before study: no
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 3
- Humidity (%): 30-70
- Air changes (per hr): 8 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk, 4x4 cm²
- % coverage: approx. 10% of the body surface
- Type of wrap if used: gauze pad (4x5 cm, Brauncel, B. Braun Petzold GmbH)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
animal weight: ca. 220 g, application volume: 0.73 ml = 0.046 ml/cm² = (1.25 g/cm³) 0.058 mg/cm²
- Concentration (if solution): 48.3%
- Constant volume or concentration used: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): 1.25 g/ml
- Concentration (if solution): 48.3%
- Lot/batch no. (if required): 11-Go4072
- Purity: 99.7%

Duration of exposure:

24 hours

Doses:

4141 mg/kg magnesium acrylate solution, 48.3%, density 1.25 g/ml

No. of animals per sex per dose:

5

Control animals:

not required

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 141 mg/kg bw

Based on:

test mat.

Remarks:

48.3 % in water

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No animal died

Clinical signs:

other: Signs of skin irritation were not observed at the site of application.

Gross pathology:

No macroscopic pathological organ alterations were observed at the end of the experiment.

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The test item "Magnesium Acrylate Solution" (48.3%) was tolerated by the male and female rats at a dose of 4141 mg/kg body weight equal to 2000 mg/kg body weight Magnesium Acrylate without any symptoms of toxicity. Signs of skin irritation were not observed at the site of application.
Thus, the LD50-value for acute dermal toxicity of Magnesium Acrylate is greater than 2000 mg/kg body weight.

Executive summary:

 The test item “Magnesium Acrylate Solution” is a slightly brownish liquid. It was tested for its acute toxicity following dermal application.

Significant acute dermal toxicity of the test item was not expected. Therefore, the limit - dose of 2000 mg/kg body weight for five male and five female rats of the strain White Wistar was chosen according to the OECD Guideline for the Testing of Chemicals No. 402 “Acute Dermal Toxicity”.

 For the dose calculation the given test item concentration of 48.3 % was taken into consideration, i.e. the animals received a dose of 4141 mg/kg of the provided solution.

 The undiluted test item was applied uniformly over the skin and the test area was bandaged for an exposure time of 24 hours.

 No signs of skin irritation were observed at the site of application. Symptoms of systemic toxicity or unusual findings after application of 2000 mg/kg body weight were not recorded at any time during the study.

 No death occurred. Body weight development of the animals remaines positive 7 days and 14 days post application.

 The necropsy 14 days after dermal application showed no macroscopic visible substance related pathologic findings.

 

Thus, the LD₅₀-value for acute dermal toxicity is higher than 4141 mg/kg for the test item “Magnesium Acrylate Solution” (48.3%) equal to 2000 mg/kg Magnesium Acrylate.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

mg/kg bw

Quality of whole database:

LD50 > 2000 mg/kg bw, reliable without restriction

Additional information

Justification for selection of acute toxicity – oral endpoint
key study

Justification for selection of acute toxicity – inhalation endpoint
Magnesium acrlyate is a salt, the melting point of the solid is higher than 300°C. Exposure of humans via inhalation by aerosols, particles or droplets of an inhalable size is not possible during manufacturing or application of the aqueous magnesium acrylate solution (concentration <50%). See Annex VIII column 2 under point 8.5.2 of the REACH regulation.

Justification for selection of acute toxicity – dermal endpoint
key study

Justification for classification or non-classification

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, Magnesium acrylate solution (48%) or magnesium acrylate in its solid form 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, Magnesium acrylate solution (48%) or magnesium acrylate in its solid form must not be classified.

No signal word or hazard statement is required.