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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2003-08-14 to 2003-10-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 2002
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
magnesium;(2S)-2-hydroxypropanoate
Cas Number:
132344-20-8
Molecular formula:
C6H10MgO6
IUPAC Name:
magnesium;(2S)-2-hydroxypropanoate
Specific details on test material used for the study:
- Name of test material (as cited in study report): Magnesium-S-lactate
- Lot/batch No.: 0208001478
- Appearance: white powder
- Purity: >98%
- Expiry date: 01 September 2007
- Storage condition of test material: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: animals were individually housed on cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet, 100 g per day
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Each animal was treated by instillation of 49.2 mg (equivalent to 0.1 mL) test substance in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test substance. The other eye remained untreated and served as the reference control.
Observation period (in vivo):
After installation of the test-substance, animals were transferred to their cages, the animals were observed and any abnormalities recorded. Examination of the eyes was conducted at 1, 24, 48, and 72 hours after test-substance application.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: according to OECD 405

TOOL USED TO ASSESS SCORE: 2% fluorescein was instilled after the 24-hour observation time point into both eyes of each animal to quantitatively determine corneal epithelial damage.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The scores for eye irritation/corrosion are given in table 1 in box " Any other information on results incl. tables". Instillation of 49.2 mg of the test substance (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae. Iridial irritation (grade 1) was observed in two animals and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness and chemosis, which had completely resolved within 24 hours in two animals and within 48 hours in one animal. Finally, there was no evidence of ocular corrosion and also no staining of (peri) ocular tissues by the test substance.

Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Results

Scored item and animal No. Observation time
Cornea 1h 24h 48h 72h Mean 24/48/72h
Rabbit 511 0 0 0 0 0
Rabbit 534 0 0 0 0 0
Rabbit 535 0 0 0 0 0
Iris 1h 24h 48h 72h Mean 24/48/72h
Rabbit 511 1 0 0 0 0
Rabbit 534 0 0 0 0 0
Rabbit 535 1 0 0 0 0
Redness 1h 24h 48h 72h Mean 24/48/72h
Rabbit 511 2 1 0 0 0.33
Rabbit 534 2 0 0 0 0
Rabbit 535 2 0 0 0 0
Chemosis 1h 24h 48h 72h Mean 24/48/72h
Rabbit 511 2 0 0 0 0
Rabbit 534 1 0 0 0 0
Rabbit 535 1 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
In a primary eye irritation study conducted according to OECD 405, Magnesium (S)-lactate was instilled into the conjunctival sac of the eye of three young adult New Zealand White rabbits. Based on the results, the test substance can be considered as non-irritating to the eye.
Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of Magnesium (S)-lactate was instilled into the conjunctival sac of one eye of each of three adult New Zealand White rabbits. Animals were observed for 7 days. Irritation was scored by the method of Draize. Only very mild conjunctival redness was observed in one rabbit, which were fully reversible within 48 hours. No signs of systemic intoxication was observed in any of the rabbits. Based on the results, the test item can be considered as not irritating.