Registration Dossier
Registration Dossier
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EC number: 687-535-9 | CAS number: 122586-52-1
Endpoint summary
Administrative data
Description of key information
Skin irritation/Corrosion: Not irritating (84/449/EWG,B.4;GLP)
Eye irritation: Not irritating (84/449/EWG,B.5;GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.4
- GLP compliance:
- yes
- Species:
- other: rbt, New Zealand WhiteChbb:NZW
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Keines "ENGLISH" None
- Duration of treatment / exposure:
- 4h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 72 d; Max. valueat end of observation period: a(related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. valueat end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Interpretation of results:
- other: not classified
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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP compliance
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG, B.5
- GLP compliance:
- yes
- Species:
- other: rbt, New Zealand WhiteChbb:NZW
- Amount / concentration applied:
- 0.1mL
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: h; Max. valueat end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Score:
- 1
- Remarks on result:
- other: Max. duration: 48 h; Max. valueat end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max. value at end of observation period: 0 (related to ail animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: h; Max.value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 14 days
- Interpretation of results:
- other: not classified
Reference
| Irritation parameter | max score | remarks |
| conjunctivae score(redness) | 1 | Max. duration: h; Max. valueat end of observation period: 0 (related to allanimals) |
| chemosis score | 0 | Max. duration: 48 h; Max. valueat end of observation period: 0 (related to allanimals) |
| cornea score iris score | 0 0 | Max. duration: h; Max. value at end of observation period: 0 (related to ailanimals)Max. duration: h; Max.value at end of observation period: 0 (related to allanimals) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
There are no in vitro skin irritation/corrosion studies available. There is one in vivo study in rabbits available.
In a primary dermal irritation study (84/449/EWG, B.4/GLP), 3 New Zealand WhiteChbb:NZW rabbits were dermally exposed (semi-occlusive) to 0.5 mL of the substance for 4 hours. The mean erythema scores at 24, 48 and 72 hr timepoints for animal 1 and 3 were 0; the mean erythema scores at 24, 48 and 72 hr timepoints for animal 2 were 1. The mean odema scores at 24, 48 and 72 hr timepoints for all animals was 0. Changes fully reversible within 7 days. The substance was not irritating.
Eye irritation
There is no in vitro eye irritation study available. There is one in vivo study in rabbits available.
In a primary eye irritation study (84/449/EWG, B.5/GLP), 0.1 mL of the substance was instilled into the eye of 3 New Zealand White Chbb:NZW rabbits. The conjunctiave score (redness) for animal 1 was 0 and for animals 2 and 3 was 1. The chemosis score for animal 1 was 0.67 and for animals 2 and 3 was 0. The cornea opacity and iris score for all animals was 0. Changes were fully reversible within 14 days. The substance was not irritating.
Justification for classification or non-classification
Based on the available information in the dossier, the substance is not classified for skin irritation/corrosion or for serious eye damage/irritation, when considering the criteria outlined in Annex I of 1272/2008/EC.
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.
