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EC number: 412-720-6 | CAS number: 156653-67-7
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- Irritation / corrosion
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 April 1993 to 04 May 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study condcuted to EU & OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 84/449/EEC
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- See below
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemisch Pharmazeutische
- Age at study initiation: 3 -5 months
- Weight at study initiation: 3.4 - 3.7 kg
- Housing: in fully air-condtioned rooms, seperate cages (arranged in a battery)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet, ad libitum and hay (approx 15g daily)
- Water (e.g. ad libitum): deionised, chlorinated water from automatic water dispenser, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 (±3C)
- Humidity (%): 55 (±20%)
- Photoperiod (hrs dark / hrs light): Lighting time 12 hours per day
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- About 24 hours before the start of the study the test eyes gf all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01 % fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
100 mg Reaktiv-Gelb F-66 923 FW was applied once to the conjunctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37 °C.
The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01 % fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes after 72 hours, further examinations were carried out after 7 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- 7 days p.a. the irritations were reversible.
- Other effects:
- From one hour up to 48 hours p.a. the conjunctiva of the animals showed slight to obvious swelling with partial eversion of lids. Additionally, up to 72 hours p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings were noted. From 24 up to 72 hours p.a. bleedings on the nictating membrane of the animals were observed.
Additional a clear from the substance discoloured discharge was observed.
Any other information on results incl. tables
Rabbit Eye Irritation Test - Readings
Animal Number |
Sex |
Eye Used |
Init Pain Reaction |
Irrigat’n |
Elapsed Time |
Cornea |
Iris |
Conjunctiva |
|||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
|||||||
67 |
F |
Left |
None |
24 Hrs |
1.0 Hrs |
0 |
0 |
0 |
2 |
2 |
2 |
1 Day |
0 |
0 |
0 |
2 |
1 |
0 |
|||||
2 Days |
0 |
0 |
0 |
2 |
0 |
0 |
|||||
3 Days |
0 |
0 |
0 |
2 |
0 |
0 |
|||||
7 Days |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
69 |
M |
Left |
None |
24 Hrs |
1.0 Hrs |
0 |
0 |
0 |
2 |
1 |
2 |
1 Day |
0 |
0 |
0 |
2 |
1 |
0 |
|||||
2 Days |
0 |
0 |
0 |
2 |
0 |
0 |
|||||
3 Days |
0 |
0 |
0 |
2 |
0 |
0 |
|||||
7 Days |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
85 |
F |
Left |
None |
24 Hrs |
1.0 Hrs |
0 |
0 |
0 |
1 |
2 |
2 |
1 Day |
0 |
0 |
0 |
1 |
1 |
0 |
|||||
2 Days |
0 |
0 |
0 |
1 |
1 |
0 |
|||||
3 Days |
0 |
0 |
0 |
1 |
0 |
0 |
|||||
7 Days |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Testing of Reaktiv-Gelb F-66 923 FW for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eye. The substance does not trigger the criteria for classification.
- Executive summary:
Testing for primary irritation in the rabbit eye provides information on ocular lesions after a single application of the test substance to the conjunctival sac of the eye and serves as a basis for classification and labelling. The present study was conducted in compliance with EEC Directive B.5. 'Acute toxicity Eye Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 405 "Acute Eye Irritation/Corrosion",in compliance with GLP.
From one hour up to 48 hours p.a. the conjunctiva of the animals showed slight to obvious swelling with partial eversion of lids. Additionally, up to 72 hours p.a. evident hyperaemie to diffuse deeper crimson coloured reddenings were noted. From 24 up to 72 hours p.a. bleedings on the nictating membrane of the animals were observed.
7 days p.a. the irritations were reversible.
Additional a clear from the substance discoloured discharge was observed.
Testing of Reaktiv-Gelb F-66 923 FW for primary eye irritation in the rabbit showed, that the substance is slightly irritating to eye.
The substance does not trigger the criteria for classification.
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.
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