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Toxicological information

Skin irritation / corrosion

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
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)

Test material

Constituent 1
Chemical structure
Reference substance name:
Strontium chloride
EC Number:
233-971-6
EC Name:
Strontium chloride
Cas Number:
10476-85-4
Molecular formula:
Cl2Sr
IUPAC Name:
Strontium chloride
Test material form:
solid: crystalline
Remarks:
White crystalline solid
Details on test material:
CAS 10476-85-4
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.

Test animals

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.

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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.

Applicant's summary and conclusion

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.

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