Magnesium ethanolate

Eye irritation

Administrative data

Endpoint:

eye 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, § 1500.42 (Eye) 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

single dose

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to DRAIZE
An irritation index is calculated as follows: The evaluation scores for cornea, iris and conjunctivae are calculated
and added up for each rabbit and at each point in time (24, 48 and 72 hr).
The sum of these findings divided by 18 is the irritation index.

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24+48+72 h

Score:

39

Max. score:

110

Reversibility:

not fully reversible within: 7 d, assumed to be reversible after 21 d

Remarks on result:

other: moderately irritating

Irritant / corrosive response data:

1 hr p.a.: slight reddening and swelling of the conjunctivae and considerable secretion.
24 hr-7 days p.a: purulent coat on the eyes in all rabbits, 3 rabbits with purulent discharge.
7 d p.a.: improvement in the 72 hr findings (7 d irritation index: 22.0), 1 rabbit with no findings (not shown).

Applicant's summary and conclusion

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Remarks:

Migrated information: = Category 2 acc. to CLP Regulation EU: 1272/2008/EC, 3.3.

Conclusions:

Magnesium ethanolate is rated to be moderately irritating to eye (Draize scoring system), which is compatible with the criteria for Category-2 irritant (corneal opacity >= 1; iritis >= 1, and reversibility within 21 d) [1272/2008/EC, 3.3.]. This corresponds to Category 2A (irritating to eyes) according to OECD GHS.