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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 402-130-7 | CAS number: 106246-33-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The robust study summary was received from the ECHA in accordance with Article 25(3) (the "12-year-rule"). ECHA helpdesk enquiry number: 06-0000024807-62-0000. The full study report is not available. The test was performed according to Directive 67/548/EEC requirements and GLP.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 402-130-7
- EC Name:
- -
- Cas Number:
- 106246-33-7
- Molecular formula:
- C21 H28 Cl2 N2
- IUPAC Name:
- 4-[(4-amino-2-chloro-3,5-diethylphenyl)methyl]-3-chloro-2,6-diethylaniline
- Details on test material:
- Nature of substance: as supplied
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 4 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 H
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 2 days
- Other effects:
- Conjunctival redness, chemosis and discharge were recorded at 1 hour ( maximum score was 2 in two animals). By 48 hours all treated eyes were normal.
Any other information on results incl. tables
It has been obtained other results concening the conjunctival redness:
Conjunctivae score redness: animal#1 ( mean score 1), Time point: overall at 24, 48 and 72 hours, score: 0.33
Conjunctivae score redness: animal#2 ( mean score 2), Time point: overall at 24, 48 and 72 hours, score: 0.33
Conjunctivae score redness: animal#3 ( mean score 3), Time point: overall at 24, 48 and 72 hours, max score: 1 ( max. duration: 48 h; max. value at the end of the observation period (related to all animals)).
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: not specified
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.
