Registration Dossier
Registration Dossier
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EC number: 810-388-0 | CAS number: 12067-23-1
Endpoint summary
Administrative data
Description of key information
Both in vitro and in vivo studies were performed in a tiered testing approach, demonstrating that tin sulfide and tin disulfide are not corrosive or irritating to skin and eye.
Based on this information it is considered that also ditin trisulfide reveals no skin or eye irritating/corrosive effect.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read-Across Justification_SnS and SnS2 to Sn2S3
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- There was no erythema or edema noted for any animal at any observation period.
There were no abnormal physical signs noted during the observation period and all body weights were normal. Therefore the test item tin sulfide is not a dermal irritant. - Other effects:
- No abnormal physical signs were noted during the observation period.
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Read-across substance tin sulfide had no skin irritating/corrosive effects in an in vivo study according to OECD guideline 404.
Based on this information it is considered that also ditin trisulfide reveals no skin irritating or corrosive effect. - Executive summary:
A skin irritation/corrosion study with rabbits according to OECD guideline 404 was performed to determine the irritant or corrosive effects, if any, of read-acrosss substance tin sulfide when applied to the skin. There was no erythema or edema noted for any animal at any observation period. Test item stained the dose sites at all observation periods. There were no abnormal physical signs noted during the observation period. All body weights were normal.
Based on this information it is considered that also ditin trisulfide reveals no skin irritating or corrosive effect.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Read-Across Justification_SnS and SnS2 to Sn2S3
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.333
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. The control eyes were normal at all observation periods. There were no abnormal physical signs noted during the observation period. Body weights increased in 2/3 animals and stayed the same in one animal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tin sulfide had no eye irritating/corrosive effect in an in vivo study according to OECD guideline 405.
Based on this information it is considered that also ditin trisulfide reveals no eye irritating/corrosive effect. - Executive summary:
The eye irritating/corrosive properties of tin sulfide were determined in a study with rabbits according to OECD guideline 405. There was no corneal opacity or iritis noted at any observation period. Conjunctival irritation, noted in 3/3 eyes after 1 hour, cleared in two animals by 24 hours and in all animals by 48 hours. There were no abnormal physical signs noted during the observation period. In summary, the mean total score at 24 hours was 0.67, at 48 and 72 hours it was 0.
Based on this information it is considered that also ditin trisulfide reveals no eye irritating/corrosive effect.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin in vitro/in vivo:
Tin sulfide and tin disulfide had no skin irritating/corrosive effects in in vitro studies according to OECD guidelines 439 and 431 as well as in an in vivo study according to OECD guideline 404.
Based on this information it is considered that also ditin trisulfide reveals no skin irritating/corrosive effect.
Eye in vitro/in vivo:
Tin sulfide and tin disulfide had no eye irritating/corrosive effect in in vitro studies (HET-CAM) and in in vivo studies according to OECD guideline 405.
Based on this information it is considered that also ditin trisulfide reveals no eye irritating/corrosive effect.
Justification for selection of skin irritation / corrosion endpoint:
GLP and guideline compliant study on a structural analogous read-across substance
Justification for selection of eye irritation endpoint:
GLP and guideline compliant study on a structural analogous read-across substance
Justification for classification or non-classification
Based on skin and eye irritation/corrosion data available for tin sulfide and tin disulfide no classification and labelling for ditin trisulfide is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria.
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.
