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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 696-318-8 | CAS number: 174489-43-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- prop-2-en-1-yl 2-(5-amino-2-chlorobenzoyloxy)-2-methylpropanoate
- EC Number:
- 696-318-8
- Cas Number:
- 174489-43-1
- Molecular formula:
- C14H16ClNO4
- IUPAC Name:
- prop-2-en-1-yl 2-(5-amino-2-chlorobenzoyloxy)-2-methylpropanoate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: Approximately 8 - 12 weeks
- Weight at study initiation: 2680 - 2790 g
- Housing: Individual
- Diet; ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- Eyes were examined and scores recorded at 1,24, 48 and 72 hours after treatment.
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- Treatment: The test article was instilled into the conjunctival sac of the left eye of each animal after gently pulling the
lower lid away from the eyeball. The lids were then gently held together for about one second.
The right eye remained untreated and served as a control.
Post-treatment wash-out: The treated eyes were gently washed with distilled water for 1 minute after the reading at 24 hours
post treatment.
SCORING SYSTEM: OECD/EEC
TOOL USED TO ASSESS SCORE: Portable hand-slit lamp (Model SL-14, Kowa Co., Dusseldorf, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 to 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no effect
- Irritant / corrosive response data:
- Hyperaemic conjunctival blood vessels (score of 1) were observed in all animals at the 1-hour reading. All eye reactions were reversed by day 1. The results of the eye examinations for individual animals are presented in Table 1.
Mean irritation scores for eye reactions are presented in Table 2. - Other effects:
- Mortality:
There was no mortality in the test.
Clinical Observations:
There were no remarkable clinical observations.
Body weights:
Body weights were not affected by treatment. Individual body weights presented din Table 3.
Classification:
According to Commission Directive 93/21/EEC, issued May 4, 1993, the results of this test indicate that CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation.
Any other information on results incl. tables
Table 1: Individual Eye Irritation Scores
SEX / ANIMAL NO. |
F / 813 |
F/ 893 |
F / 836 |
|||
|
CORNEA |
|||||
|
CE |
TE |
CE |
TE |
CE |
TE |
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
|
IRIS |
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
|
CONJUNCTIVAL REDNESS |
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS |
0 0 0 0 |
1 0 0 0 |
0 0 0 0 |
1 0 0 0 |
0 0 0 0 |
1 0 0 0 |
|
CONJUNCTIVAL CHEMOSIS |
|||||
AFTER 1 HOUR AFTER 24 HOURS AFTER 48 HOURS AFTER 72 HOURS |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
CE: CONTROL EYE TE: TEST EYE |
||||||
Table 2: Summary Eye Irritation Indices (OECD/EEC)
Mean Scores for 24, 48 and 72 hour readings
SEX / ANIMAL NO. |
F / 813 |
F/ 893 |
F / 836 |
MEAN |
CORNEA |
0 |
0 |
0 |
0 |
IRIS |
0 |
0 |
0 |
0 |
CONJUNCTIVAL REDNESS |
0 |
0 |
0 |
0 |
CONJUCTIVAL CHEMOSIS |
0 |
0 |
0 |
0 |
Table 3: Body Weights (g)
SEX / ANIMAL NO. |
F / 813 |
F/ 893 |
F / 836 |
AT TEST START AT TEST END (3 DAYS) |
2680 2760 |
2690 2720 |
2790 2880 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.
- Executive summary:
An eye irritation/corrosion test was conducted with test article CA 2219 A (Intermediate of CGA 276854) (batch 249-GE001/SU). The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment.
Redness of the conjunctiva was observed in all animals at the 1-hour reading. All eye reactions were clear by day 1. There was no mortality. No remarkable clinical observations were recorded. Body weights were not affected by treatment.
According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.
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.
