Magnesium ethanolate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study based on national / international standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: US Fed. Reg. 38, No. 187, § 1500.41 (skin) P. 27019 of 27 Sep. 1973.

GLP compliance:

no

Remarks:

not yet stipulated at that time

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium ethanolate

EC Number:

219-323-5

EC Name:

Magnesium ethanolate

Cas Number:

2414-98-4

Molecular formula:

C2H6O.1/2Mg

IUPAC Name:

magnesium ethanolate

Details on test material:

- Name of test material (as cited in study report): Magnesium ethylate
- Molecular formula (if other than submission substance): Mg(OC2H5)2
- Molecular weight (if other than submission substance): 114.43
- Substance type: organometallic
- Physical state: solid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: not stable
- Storage condition of test material: Sensitive to hydrolysis and air

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Weight at study initiation: 3 - 4 kg
- Housing: stainless-steel cage without litter, 1 animal per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: > 3 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1
- Humidity (%): 55 +-10
- air-conditioned
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved: intact and abraded site

Vehicle:

other: peanut oil

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50 % in anhydrous peanut oil

VEHICLE
- Amount(s) applied (volume or weight with unit): 1 g
- Concentration (if solution): 50 % pasty suspension

Duration of treatment / exposure:

24 h

Observation period:

7 d

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: approx. 2.5 cm x 2.5 cm = approx. 6.25 cm2
- Type of wrap if used: Gauze is fastened with an elastic bandage, on top PVC film fixed with adhesive plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): on data

SCORING SYSTEM: according to Draize, J.H. (1959) DERMAL TOXICITY

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Remarks:

based on Draize Scoring System

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24 + 72 h

Score:

0.46

Max. score:

8

Irritant / corrosive response data:

Very slight edema (score 1) have been reported on the intact skin of 2/6 animals after 72 h;
Very slight and slight edema (score 1 and 2) have been reported on the scarified skin of 5/6 and 1/6 animals, respectively, after 72 h.
No edemas were noted (score 0).

Other effects:

In 3 rabbits, brownish colorations were found in the scarified skin area.
The subcutaneous connective tissue and the muscles underneath were unremarkable.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Magnesium ethanolate can be considered as non-irritating to the skin.