Magnesium

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented study which meets basic scientific principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

- Name of test material (as cited in study report): Magnesium chloride hexahydrate
- Physical state: Colourless; Solid, crystals
- Stability after opening: Instable after repeated contact to air
- Storage condition of test material: At room temperature, in a tightly closed package.
- pH: 5.5 - 7.0 (5% solution at 20 °C)
- Solvent: Water

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium chloride

EC Number:

232-094-6

EC Name:

Magnesium chloride

Cas Number:

7786-30-3

IUPAC Name:

magnesium dichloride

Test material form:

solid: compact

Details on test material:

- Name of test material (as cited in study report): Magnesium chloride hexahydrate
- Physical state: Colourless; Solid, crystals
- Stability after opening: Instable after repeated contact to air
- Storage condition of test material: At room temperature, in a tightly closed package.
- pH: 5.5 - 7.0 (5% solution at 20 °C)
- Solvent: Water

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS (The animals were derived from a controlled full barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes.)
- Source: Charles River Deutschland, D-97633 Sulzfeld, Germany
- Age at study initiation: approximately 21 weeks old
- Weight at study initiation: Animal No. 1: 4.1 kg; Animal No. 2: 4.0 kg; Animal No. 3: 3.9 kg
- Housing: Semi-barrier in an air-conditioned room; Housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet: Free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 1208), rich in crude fibre
- Water: Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3°C
- Relative humidity: 55 +/- 10%
- Air changes: At least 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.1 g of the test item was applied to the test site. The test item was applied at a single dose in the conjunctival sac of one eye of each test animal after pulling the lower lid away from the eyeball. The lids were then gently held together for about 1 second in order to prevent loss of the material. The untreated contralateral eye served as control.
No further information on the amount/concentration applied was stated.

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

Observation at 1, 24, 48, and 72 hours and 4 to 6 days

Number of animals or in vitro replicates:

3

Details on study design:

The in vivo test was performed initially using one animal. The results of the initial test did not indicate the test item to be corrosive or a severe irritant to the eye using the procedure described. In order to confirm the response, two additional animals were treated in the same manner.

PREPARATION OF THE ANIMALS.
Approximately 24 hours before the test and immediately prior to the application both eyes of each animal were examined. A health inspection was performed to ensure the good state of health of the animals. None of the animals showed eye irritation, ocular defects, or pre-existing corneal injury.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were not rinsed.

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 72 hours post-instillation as well as at the end of the prolonged observation period the treated eyes were examined with the aid of a fluorescein solution (Fluoreszein SE Thilo, lot no. H 901, expiry date: 12/2010).

-OTHER: The eyes were examined for signs of irritation throughout the observation period. Nature, severity and duration of all lesions observed were described.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

1.67

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.67

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 6

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 7

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 8

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 9

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

0

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The test item produced irritant but reversible ocular effects after instillation into the eyes of 3 female rabbits.
Upon fluorescein examinations at the end of the observation period of 72 h and further at the end or prolonged observation period no corneal lesions were found in any animal.
Conjunctival discharge was observed in all animals, 1 hr post-instillation. No conjunctival discharge was observed 2 days post-instillation in all the animals.
Conjunctival redness and chemosis were also observed in all animals.

Other effects:

Neither mortalities nor significant clinical signs of toxicity were observed. There were no significant body weight changes during observation period.

Any other information on results incl. tables

Eye Irritation Scores – Animal No. 1

 

	Single data				Average score (24, 48 and 72 hours)
	Time post application
	1 hour	24 hours	48 hours	72 hours
	T/C	T/C	T/C	T/C
Cornea	0/0	0/0	0/0	0/0	0
Iris	0/0	0/0	0/0	0/0	0
Conjunctival redness	2/0	2/0	2/0	1/0	1.67
Conjunctival chemosis	3/0	1/0	1/0	0/0	0.67

 

	Single data
	Time post application
	4 days	5 days	6 days	7 days	8 days
	T/C	T/C	T/C	T/C	T/C
Cornea	0/0	0/0	0/0	-	-
Iris	0/0	0/0	0/0	-	-
Conjunctival redness	1/0	1/0	0/0	-	-
Conjunctival chemosis	0/0	0/0	0/0	-	-

 

Eye Irritation Scores – Animal No. 2

 

	Single data				Average score (24, 48 and 72 hours)
	Time post application
	1 hour	24 hours	48 hours	72 hours
	T/C	T/C	T/C	T/C
Cornea	0/0	0/0	0/0	0/0	0
Iris	0/0	0/0	0/0	0/0	0
Conjunctival redness	2/0	2/0	1/0	1/0	1.33
Conjunctival chemosis	2/0	1/0	1/0	1/0	1.0

 

	Single data
	Time post application
	4 days	5 days	6 days	7 days	8 days
	T/C	T/C	T/C	T/C	T/C
Cornea	0/0	-	-	-	-
Iris	0/0	-	-	-	-
Conjunctival redness	0/0	-	-	-	-
Conjunctival chemosis	0/0	-	-	-	-

Eye Irritation Scores – Animal No.3

 

	Single data				Average score (24, 48 and 72 hours)
	Time post application
	1 hour	24 hours	48 hours	72 hours
	T/C	T/C	T/C	T/C
Cornea	0/0	0/0	0/0	0/0	0
Iris	0/0	0/0	0/0	0/0	0
Conjunctival redness	2/0	2/0	0/0	0/0	0.67
Conjunctival chemosis	2/0	1/0	0/0	0/0	0.33

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the present study, single ocular instillation of the test item Magnesium chloride hexahydrate to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible. Neither mortalities nor significant clinical signs of toxicity were observed.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments on the approximation of the laws, regulations and administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present test conditions magnesium chloride hexahydrate was non-irritating to eyes, hence, no labelling is required.
According to the EC Regulation 1272/2008 and subsequent regulations, the test item is non-irritating to eyes; no classification and labelling of the substance is necessary.