Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-854-8 | CAS number: 543-94-2
Skin irritation / corrosion
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:
- 1 997
- 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
- 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
Constituent 1
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
