Strontium carbonate

Endpoint summary

Description of key information

Skin irritation: not irritating
Eye irritation: not irritating

Respiratory irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not examined

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the read-across from Strontium chloride, Strontium carbonate is not expected to be a skin irritant or a skin corrosive.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information is included as attachment in Section 13.

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Value:

118

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the read-across from Strontium nitrate, Strontium carbonate is not expected to be a skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002-04-24

Deviations:

no

GLP compliance:

yes

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

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.

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Skin irritation:

Two key studies are used for read-across to Strontium carbonate:

1) An in vitro skin irritation study performed on Strontium nitrate (Verbaan, 2010): Mean relative viability of 118% evaluated by MTT reduction, after 15 min incubation. The classification criteria according to regulation (EC) 1272/2008 as irritating to skin are not met since the mean rel. viability is >50% of the control, hence no classification required. The in vitro study according to the draft EC method B.46 (EpiSkin^TM) was validated and considered of being a reliable and relevant stand-alone test for predicting rabbit skin irritation, and for being used as a replacement of in vivo method OECD 404 for the purposes of distinguishing between R38 skin irritating and non-skin irritating test substances (ECVAM, 27.04.2007).

 

2) An in vivo skin irritation study performed on Strontium chloride (Allen, 1997): Erythema & edema score:0 (in all animals at 24, 48 and 72h). The classification criteria according to regulation (EC) 1272/2008 as irritating to skin are not met since no effects were observed, hence no classification required.

 

Eye irritation:

Reference Stitzinger (2010) is considered as the key study for eye irritation and will be used for classification.

The overall irritation results are as follows: Cornea score: 0 (in all animals at 24, 48 and 72h); Iris score: 0 (in all animals at 24, 48 and 72h); Chemosis score: max. 1 (in two of three animals). The effects were reversible within 72h. Hence, the substance does not meet the criteria for eye irritation according to regulation (EC) 1272/2006. No labeling is required.

 

Respiratory irritation:

The classification as respiratory irritant is covered under the endpoint specific target organ toxicity- single exposure and repeated exposure. Please refer to the endpoint summaries on acute toxicity (endpoint 7.2) and repeated dose toxicity (endpoint 7.5) for further information.