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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-716-0 | CAS number: 1345-07-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-29 to 2012-06-01
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Official Journal L 216, 16/6/2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibismuth trisulphide
- EC Number:
- 215-716-0
- EC Name:
- Dibismuth trisulphide
- Cas Number:
- 1345-07-9
- Molecular formula:
- Bi2S3
- IUPAC Name:
- dibismuth trisulphide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species / Strain: New Zealand White rabbit
Source: S & K LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
Sex: male
Age of animals: Young adult rabbits
Body weight range at the beginning of the study: 3435-3487 g
Body weight range at the end of study: 3590-3640 g
Acclimatisation time: 54 days
Housing: Animals were housed individually in metal cages.
Diet: P. Strengthened Female Hare Mixed diet produced by AGRIBRANDS Europe Hungary PLC, H-7400 Kaposvár, Hungary, ad libitum
Water: tap water from watering bottles ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- A weight of 0.1 g of the undiluted test item Dibismuth trisulfide (Bi2S3) was used for the study in pure state, in a single dose.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of test item.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- In the first step an initial test was performed using one animal. The test item was firstly well grinded and was poured into the conjunctival sac of
the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test item. The contralateral eye served as control.
Immediately after the administration of the test item, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Before the administration, the eyes of the second and the third animal were not anaesthetised, because the score of initial pain reaction was 0 in
the first animal. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48 and 72 hoursafter the application. The duration of the observation period was sufficient for the statement of reversibility or irreversibility of changes.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: The max. score gives the max. reachable score.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The max. score gives the max. reachable score.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The max. score gives the max. reachable score.
- Irritation parameter:
- other: redness
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: The max. score gives the max. reachable score.
- Irritation parameter:
- other: discharge
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- other: The max. score gives the max. reachable score.
- Irritant / corrosive response data:
- One hour after treatment, some conjunctival hyperaemic blood vessels (score 1) were observed in two animals. The amount
of discharge was different from normal (score 1) in all animals.
24 hours after treatment, all animals became free of symptoms.
48 hours after treatment, all animals were free of symptoms.
72 hours after the treatment the study was terminated, since no primary irritation symptoms occurred.
During the study the control eyes of the animals were symptom-free.
General state and the behaviour of the animals were normal throughout the study period. There were no effects on body weight attributable to the treatment with the test item during the contact and observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, test item Dibismuth trisulfide (Bi2S3) applied to the rabbits' eye mucosa, caused slight conjunctival irritant effects, fully reversible
within 24 hours.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category. - Executive summary:
In conclusion, test item Dibismuth trisulfide (Bi2S3) applied to the rabbits' eye mucosa, caused slight conjunctival irritant effects, fully reversible
within 24 hours.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.
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.
