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[3-(Hydroxy-kO)-4-{[2-(hydroxy-kO) carbopolycyl-1-yl]diazenyl-kN1}-6-substituted-carbopolycyle-1-sulfonato(3-)]chromium, reaction products with hydrogen amino-4-hydroxy carbopolycyle-2-sulfonate, sodium 2-[(aminophenyl)sulfonyl]ethyl sulfate, amino-5-substituted-phenol and 2,4,6-trichloro-1,3,5-triazine
EC number: 454-620-5 | CAS number: 854270-57-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Terrestrial toxicity
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- Toxicological Summary
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- Irritation / corrosion
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- Additional toxicological data
![](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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Ltd, CH-4452 Itingen, Switzerland
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 40821/A
- Purity: Approx. 81%
- Lot/batch No.: TVR1
- Expiration date: 1 February 2010
- Stability of test item: Stable under storage conditions
- Storage condition: At room temperature (range of 20 ± 5°C), light and moisture (desiccator) protected.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, BP 0109, F-69592 L'Arbresle
- Age at treatment: 11-12 weeks (male), 10-12 weeks (females)
- Housing: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 74/04, Provimi Kliba AG) were provided for gnawing.
- Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 2/05) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
- Water: Community tap water from Füllinsdorf, ad libitum.
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 17 days
- Observation period (in vivo):
- up to 17 days
- Number of animals or in vitro replicates:
- 1 male, 2 females
- Details on study design:
- TREATMENT:
The eyes of the animals were examined one day prior to test item administration. Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test. On the day of treatment, 0.1 g of FAT 40821/A was placed in 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 to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
OBSERVATIONS:
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
SCORING SYSTEM:
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 2004/73/EC, April 29, 2004 at approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, and 17 days after instillation. Additionally, ocular discharge, reddening of the sclerea and staining of conjunctivae, sclerea and cornea by the test item was assessed.
TOOL USED TO ASSESS SCORE:
Eye examinations were made with a Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach/Switzerland).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 and 72 hours
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1.67
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48, 72 hours and 7, 10, 14, 17 days
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- - Very slight corneal opacity affecting the whole area which was attributed to marked black staining caused by the test item was noted in one animal one hour after treatment. No abnormal findings were observed in the cornea of the remaining two animals and in the iris of any animal at any of the measurement intervals. Moderate reddening of the conjunctivae was noted in two animals at the 1-hour reading whereas the remaining animal was not assessable due to the staining produced by the test item and the opacity produced by the staining at the same reading time. Slight to moderate reddening of the conjunctivae was noted in all animals at the 24-hour examination and persisted as slight reddening of the comjunctivae up to the 72-hour reading. Slight to marked swelling (chemosis) of the conjunctivae with half-closed lids was observed in the three animals one hour after instillation and persisted as slight swelling in one animal until the 24-hour reading. Moderate reddening of the sclerea was present in two animals at the 1-hour reading whereas the remaining animal was not assessable due to the swelling produced by the test item. Slight to moderate reddening of the sclerea was noted in all animals at the 24-hour examination and persisted as slight reddening of the sclerea in one animal until the 48-hour reading and in the other animal up to the 72-hour reading. Slight to moderate ocular discharge was observed in all animals one hour after treatment and persisted as slight ocular discharge in one animal until the 24-hour examination. No abnormal findings were observed in the treated eye of any animal 7 days after treatment.
- No corrosion of the cornea was observed at any of the reading times. - Other effects:
- - Slight to marked black staining produced by the test item was noted in all animals at the 1-hour reading and persisted as slight black staining in two animals up to test day 14. Black remnants of the test item were observed in the eye or conjunctival sac of two animals one hour after treatment.
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. One animal screamed after the application.
- The body weights of all rabbits were considered to be within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be not irritating or corrosive to the rabbit eye.
- Executive summary:
In a GLP compliant eye irritation study, performed according to OECD guideline 405, test substance (0.1 g) was placed in the conjunctional sac of the left eye of 3 New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours, as well as 7, 10, 14, and 17 days after test item instillation. The test substance showed a mean cornea score of 0.33 after 1 hour and 0 at the other time points (24 -72 hours, 7 -17 days). The conjunctivae score was 2 and 1.33 after 1 and 24 hours, respectively. After 48 and 72 hours, a score of 1 was observed and a score of 0 was present at the other time points (7 - 17 days). The chemosis score was 1.67 after 1 hour, 0.33 after 24 hours and 0 at the other time points (48, 72 hours and 7 - 17 days). The iris score was 0 during the whole observation period. No corrosion of the cornea was observed at any of the measuring intervals. Under the conditions of this experiment, the test substance was found to be not irritating or corrosive.
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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