Magnesium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2009 till March 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

May 2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

magnesium chloride hexahydrate

IUPAC Name:

magnesium chloride hexahydrate

Constituent 2

Reference substance name:

7791-18-6

Cas Number:

7791-18-6

IUPAC Name:

7791-18-6

Details on test material:

water content (specification): 51-55% (53.4%)
Colour: colourless
Physical state: solid, crystals
Storage: at room temperature, in a tightly closed package
Solvent: water
Stability after opening: instable after repeated contact to air
pH: 5.5 - 7.0 (5% solution at 20° C)

Specific details on test material used for the study:

- 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
No further information on the test material was stated.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Species/strain: Healthy New Zealand White Rabbits, Crl: KBL (NZW)
Source: Charles River Deutschland, D-97633 Sulzfeld
Sex: female
Body weight at the beginning of the study: > 2kg
Age at the beginning of the study: approximately 21 weeks old
The animals were derived from a controlled full barrier maintained breeding system (SPF).

Housing and Feeding Conditions: semi-barrier in an air-conditioned room, temperature: 18 (+/-3)°C, relative humidity: 55 (+/-10)%, artificial light, sequence being 12 hours light, 12 hours dark, air change: at least 10 x / hour, free access to autoclaved hay and to Altromin 2123 maintenance diet for rabbits, rich in crude fibre, free access to water, housed in ABS - plastic rabbit cages, floor 4200 cm2 and adequate acclimatisation period (at least 5 days).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated contralateral eye served as control.

Amount / concentration applied:

A dose of 0.1 g of the test item was applied to the test site.

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 female rabbits

Details on study design:

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.

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. 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

The eyes were examined for signs of irritation throughout the observation period. Individual reactions of each animal were recorded at each time of observation. The observations were recorded by a toxicologist and confirmed by another. Nature, severity and duration of all lesions observed were described. For the calculation only the 24-, 48- and 72-hour readings were used.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

other: Each animal showed no cornea opacity at any time

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

other: Each animal showed no iris effect at any time

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.67

Max. score:

2

Reversibility:

fully reversible within: 6 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible within: 4 days

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Other effects:

There were no significant body weight changes, no individual systemic and local findings during the 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:

GHS criteria not met

Conclusions:

Under the conditions of this study, MgCl2, 6H2O is not irritating to eye.

Executive summary:

Under the conditions of this 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 within 6, 4 and 2 days post-instillation in animal no. 1, 2 and 3, respectively.

Neither mortalities nor significant clinical signs of toxicity were observed.

According to the GHS criteria, the MgCl2, 6H20 is not irritating to eyes.