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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 683-287-0 | CAS number: 877670-90-1
Eye irritation
Administrative data
- 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: GLP study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid
- EC Number:
- 683-287-0
- Cas Number:
- 877670-90-1
- Molecular formula:
- C18H17N3O5
- IUPAC Name:
- 2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid
- Details on test material:
- Batch 939-76
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1g
- Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- animal: 9529
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- animal: 9537
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Remarks:
- animal: 9533
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 9529
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 9537
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal: 9533
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal: 9529
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal: 9537
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- animal: 9533
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 1.33
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 9529
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 9537
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal: 9533
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- animal: 9529
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- animal: 9537
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Remarks:
- animal: 9533
- Time point:
- other: 24, 48, 72 hour reading
- Score:
- 0
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item ANTHRANILIC ACID-AAOA, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which was reduced at 24 hours afer application. The effects were fully reversible within 72 hours. According to directive 2001/59/EC, ANTHRANILIC ACID-AAOA does not require classification as an eye irritant.
- Executive summary:
The acute eye irritation study of the test item ANTHRANILIC ACID-AAOA was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002). The test item was placed into the conjunctival sac of left eye of each animal. The untreated right eyes served as control. 0.1 g of the test item was used for the study in pure state, as a single dose. The eyes of the test animals were not washed out after the application of test item. The eyes were examined at 1, 24, 48, 72 hours after the application. The untreated right eye served as control. One hour after the single application of test item ANTHRANILIC ACID-AAOA into the eye of the rabbits, conjunctival redness (severity 3) and discharge (severity 3) were observed in all animals. At 24 hours after treatment conjunctival redness was observed in all animals (severity 2 in two animals and severity 3 in one animal). At 48 hours after the treatment conjunctival redness (severity 1) was observed in all animals. At 72 hours after treatment all animals were symptom-free. During the study the control eye of animals were symptom-free. There were no mortality or systemic clinical changes related to ANTHRANILIC ACID-AAOA administration in rabbits observed at the animal general examination performed daily. Body weight values of ANTHRANILIC ACID-AAOA-treated animals measured at termination of study showed normal changes compared to the pre-treatment values. The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows: chemosis : 0.00, 0.00, 0.00 discharge : 0.00, 0.00, 0.00 redness : 1.00, 1.00, 1.33 cornea opacity : 0.00, 0.00, 0.00 iris : 0.00, 0.00, 0.00 The test item ANTHRANILIC ACID-AAOA, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which was reduced at 24 hours afer application. The effects were fully reversible within 72 hours. According to directive 2001/59/EC, ANTHRANILIC ACID-AAOA does not require classification as an eye irritant.
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.
