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Administrative data

Description of key information

Based on read-across approach (experimental result on strontium chloride), the substance is not classifed regarding skin corrosion/irritation.

Based on experimental results, the substance is not classified regarding eye irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996-11-26 to 1996-11-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Guideline study reliable with restrictions Minor deviations from the guideline with no effect on the results: - The purity and the stability of the test material was missing in the study report. - According to the guideline, fur should be removed from the dorsal area of the trunk. In this study the fur was removed from the dorsal flank area. - According to the guideline, the individual weights of animals at the conclusion of the test should be stated. This information was missing in the study report.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Also according to method B4 of Commission Directive 92/69/EEC
Deviations:
yes
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Strontium chloride-6-hydrate extra pure
- EC number: 233-971-6
- Physical state: White crystalline solid
- Storage condition of test material: Ambient temperature (< 25 °C), under artificial light
No further information on the test material was stated.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: twelve to sixteen weeks old
- Weight at study initiation: 2.85 to 3.16 kg
- Housing: The animals were individually housed in suspended metal cages.
- Diet (ad libitum): STANRAB SQC Rabbit Diet, Special Diets Services Ltd., Witham, Essex, UK
- Water (ad libitum): Mains drinking water
- Acclimation period: Minimum acclimatisation period of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 19 °C
- Relative humidity: 49 to 52 %
- Air changes: Approx. fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A quanity of 0.5 g of the test material, moistened with 0.5 ml of distilled water.
No further information on the amount/concentrations applied was stated.
Duration of treatment / exposure:
4 hour
Observation period:
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary cippers.On the day of the test a suitable test site was selected on the back of each rabbit.
- Type of wrap if used: The test material moistened with water, was introduced under a 2.5 cm X 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximately size 2.5 cm X 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after application the corset and pathces were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: Draize scoring system
Any other skin reactions, if present, were also recorded.
No further information on the study design was stated.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reactions were noted during the study.
Other effects:
No skin reactions were noted during the study.
Interpretation of results:
GHS criteria not met
Remarks:
not irritating
Conclusions:
The test material, strontium chloride-6-hydrate extra pure, is not irritating. No corrosive effects were noted.
According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as irritating.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as irritating.
Executive summary:

The test material, strontium chloride-6-hydrate extra pure (EC number: 233-971-6), was tested according to OECD 404 guidline, on 3 male New Zealnd White rabbits. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined.

The test material is not irritating. No corrosive effects were noted.

According to the criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as irritating.

According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as irritating.

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:
December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- identification: STRONTIUM ACETATE
- Batch No.: 17025 25/26/28
- Cas No.: 14692-29-6
- Date received: 13 June 2017
- Storage: room temperature
- Container: opaque plastic flask (n=1)
- Form: fine crystals
- Quantity: 25.40 g (container + content)
- Colour: white
- Production date: 13 May 2017
- Expiry date:13 May 2020

It was identified under the code number: PH-17/0377. The test item was used as supplied in the study.
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals:
Three female albino New Zealand rabbits were supplied by Hypharm (F-49450 La Renaudiere). The animals were kept during a minimal 5-day acclimatisation period. At the beginning of the test, the animals were 11 weeks old. They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear.

Housing:
Each animal was kept in an individual box installed in conventional air conditioned animal husbanding:
The temperature and relative humidity of the main test were controlled to remain within target ranges of 17°C to 23°C and 30% to 70%, respectively.
The rate of air exchange was at least ten changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink:
Drinking water (tap-water from public distribution system) and foodstuff (ENVIGO – 2030C) were supplied ad libitum.
Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas - Eurofins (FRANCE).

Treatment:
0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item. The other eye remained untreated serving as control.
Initially, a single animal was treated. After consideration of the responses in the first animal, two additional animals were treated under the same experimental conditions.

Grading of reactions:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
0.1 g of the test item was instilled, after being reduced in fine powder, into the conjunctival sac of one eye after gently pulling the lower lid away from the eyeball.
Duration of treatment / exposure:
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Observation period (in vivo):
Ocular examinations were performed on both right and left eyes 1 hour, 24, 48 and 72 hours following treatment.
Number of animals or in vitro replicates:
Three female albino New Zealand rabbits.
Irritation parameter:
chemosis score
Remarks:
Mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6670
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6674
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
Redness (mean)
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
iris score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Remarks:
mean
Basis:
animal: A6675
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight to moderate and totally reversible:
- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.
- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.
- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.
Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM ACETATE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No symbol and warning label are required.
Executive summary:

The test item STRONTIUM ACETATE was instilled, as supplied, into the eye of three New Zealand rabbits at the dose of 0.1 g. The experimental protocol was established on the basis of the official method as defined in the O.E.C.D. Test Guideline No. 405 dated October 2nd, 2012.

The ocular reactions observed during the study have been slight to moderate and totally reversible:

- At the conjunctivae level: a slight to moderate redness noted 24 hours after the test item instillation and totally reversible between days 2 and 3; associated with a slight to moderate chemosis noted 1 hour after the test item instillation and totally reversible between days 2 and 3.

- At the iris level: an injection was noted 1 hour after the test item instillation in two animals and was totally reversible on day 1.

- At the corneal level: a slight opacity, noted 24 hours after the test item instillation in two animals and totally reversible on day 2.

In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item STRONTIUM ACETATE does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.

No symbol and warning label are required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Based on read-across approach, the substance is not classifed regarding skin corrosion/irritation.

Based on experimental results, the substance is not classified regarding eye irritation.

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