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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:
key study
Study period:
2010-05-27 to 2010-07-07
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
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002-04-24
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Strontium carbonate
EC Number:
216-643-7
EC Name:
Strontium carbonate
Cas Number:
1633-05-2
Molecular formula:
CH2O3.Sr
IUPAC Name:
strontium carbonate
Details on test material:
- Name of test material (as cited in study report): Strontium carbonate
- Molecular formula (if other than submission substance): SrCO3
- Molecular weight (if other than submission substance): 147.6 g/mol
- Physical state: solid, odourless white powder
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
- Source: Harlan, Belton, Leics, England
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1 kg
- Housing: Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
- Diet: Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21.0 ± 3.0ºC (actual range: 18.8 – 23.4ºC)
- Relative humidity: 40-70% (actual range: 38 - 81%)
- Air changes: Approximately 15 air changes/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): Animals were treated by instillation of, on average, 99.2 mg (range 98.9 - 99.6 mg) of the 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.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
No data
Observation period (in vivo):
Approx. 1, 24, 48 and 72 hours and 7 days (all animals) and 14 and 21 days (two animals) after instillation of the test substance.
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The study was started by treatment of a single rabbit (sentinel). The two other animals were treated in a similar manner 9 days later, after considering
the degree of eye irritation observed in the first animal.

SCORING SYSTEM: Draize scoring system. Other (local) effects were also recorded

TOOL USED TO ASSESS SCORE: Immediately after the 24-hour observation, a solution of 2% fluorescein (Merck, Darmstadt, Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage. This procedure was repeated to assess
recovery.
Where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp. In cases of equivocal results when comparing the treated and untreated eyes, the illustrated guide from the Consumer Product Safety Commission, Washington, D.C. 20207 was used for additional control purposes.

OBSERVATIONS:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weight: Day treatment (prior to instillation) and after the final observation
Necropsy: Not performed
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:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0.7
Max. score:
0
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
Instillation of approximately 75 mg of Strontium Carbonate (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 and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours. No corneal opacity was observed and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage.
Remnants of the test substance were present in the eye on Day 1 and on the outside of the eyelids on Days 2, 3 and/or 4. No staining of (peri) ocular tissues by the test substance was observed. There was no evidence of ocular corrosion.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures, strontium carbonate should not be classified as irritant substance to eyes.
Executive summary:

Based on these results Strontium Carbonate does not have to be classified and has no obligatory labeling requirement for eye irritation according to the:

- Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2007),

- Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures.