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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 276-769-3 | CAS number: 72705-22-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- EC Number:
- 276-769-3
- EC Name:
- Ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- Cas Number:
- 72705-22-7
- Molecular formula:
- C12H15NO6S.H3N
- IUPAC Name:
- ammonium 4-acetoacetylamino-5-methoxy-2-methylbenzenesulphonate
- Details on test material:
- purity: 90 % contains residual water
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Weight at study initiation: 2.9 - 3.7 kg
- Housing: in single cages located in completely air conditioned rooms
- Diet: Altromin 2013 Zuchtdiät - Kaninchen (Altromin GmbH, Lage/Lippe), ad libitum
- Water: deinized and chlorinated water from automatic dispensors, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-2
- Humidity (%): 55+-10
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- physiological saline
- Controls:
- other: the untreated right eye of the animal was used as control
- Amount / concentration applied:
- 100 mg test item suspended with 0.1 ml 0.9 % NaCl-solution
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with saline solution (37°C)
- Time after start of exposure: 24 hour
SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae redness: 0 - 3; chemosis: 0 - 4
TOOL USED TO ASSESS SCORE: UV lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test result the substance can be considered as not irritating to the eyes.
- Executive summary:
The substance was tested for eye irritation to albino New Zealand rabbits according to OECD guideline 405. 100 mg of the test item suspende in 0.1 ml saline solution was applied in the conjunctivae sac of the left eyes. 24 hours after application the substance was removed by washing with warm (37°C) saline solution and the signs were rated according the Draize system. There were no effects on iris and cornea. Small effects were noticed at the conjunctivae of one out of three animals 24 hours after application. After the observation period of 4 days all signs of irritation were reversible.
Therefore, the substance is not irritating to the eyes.
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.
