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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-996-4 | CAS number: 102-01-2
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: Well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetoacetanilide
- EC Number:
- 202-996-4
- EC Name:
- Acetoacetanilide
- Cas Number:
- 102-01-2
- Molecular formula:
- C10H11NO2
- IUPAC Name:
- 3-oxo-N-phenylbutanamide
- Details on test material:
- - Name of test material (as cited in study report): Acetessiganilid TTR
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- Number of animals: 3
- Identification: numbered eartags
- Weight: 3.1 - 3.5 kg
- Age: 3 - 5 months
- single cages in air-conditioned rooms
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Diet: Altromin 2123, ad libitum, as well as hay (about 15 g daily)
- Water: deionised, chlorinated water from automatic feeders, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- -Amount applied: 100 mg test substance
- Duration of treatment / exposure:
- Single treatment, exposure for 24 hrs. The remaining test substance was removed with lukewarm tap water at the end of the exposure period.
- Observation period (in vivo):
- examinations were done 1, 24, 48 and 72 hrs after application of test substance
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Reversibility:
- other: no signs of irritation at any time
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Reversibility:
- other: no signs of irritation at any time
- Irritation parameter:
- iris score
- Basis:
- other: animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: initial, slight effects were fully reversible within 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- other: animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- other: animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hrs
- Other effects:
- colourless discharge one hour after application
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test the test substance is not eye irritating.
- Executive summary:
Acetessiganilid TTR was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the test substance were placed into the conjunctival sac of the left eye of 3 New Zealand White Rabbits. The right eye served as untreated control. 24 h after application the remaining substance was rinsed with physiol. saline. The animals were periodically examined for signs of eye irritation. Mean scores (mean of 24, 48, and 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.
All mean scores calculated were below threshold values and indicate, that the substance is not irritating to eyes. All effects were fully reversible within 72 h.
Based on the findings in this test the test substance is not eye irritating.
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.
