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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Strontium di(acetate)
- EC Number:
- 208-854-8
- EC Name:
- Strontium di(acetate)
- Cas Number:
- 543-94-2
- Molecular formula:
- Sr(C2H3O2)2
- IUPAC Name:
- strontium di(acetate)
- Test material form:
- solid: particulate/powder
Constituent 1
- 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.
Test animals / tissue source
- 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.
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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.
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.
