Registration Dossier

Diss Factsheets

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
Study period:
2010-02-03 to 2010-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, 2002-04-24
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
signed 2009-04-06

Test material

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
Constituent 2
Reference substance name:
7791-18-6
Cas Number:
7791-18-6
IUPAC Name:
7791-18-6
Constituent 3
Reference substance name:
magnesium chloride hexahydrate
IUPAC Name:
magnesium chloride hexahydrate
Test material form:
solid: crystalline
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
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:
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
No further information on the test animals was stated.

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:
No data
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:
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.
No further information on the study design was stated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 6 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 4 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 days
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0.33
Max. score:
4
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.

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.

Categories Display