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.
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